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1. Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non‐small cell lung cancer: A randomized, double‐blind, phase III study

Author

Likun Chen, Jose David Gomez Rangel, Timucin Cil, Xingya Li, Irfan Cicin, Yihong Shen, Zhihua Liu, Ozgur Ozyilkan, Bondarenko Igor, Jun Chen, Kostiuk Oleksandr, Zhendong Chen, Helong Zhang, Ziyi Fu, Qingfeng Dong, Shuqiang Song, Jin‐Chen Yu, and Li Zhang

Subjects
bevacizumab, biosimilar, efficacy, nonsquamous non‐small cell lung cancer, safety, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background BAT1706 is a proposed biosimilar of bevacizumab (Avastin®). We aimed to compare the efficacy and safety of BAT1706 with that of EU‐sourced reference bevacizumab (EU‐bevacizumab) in patients with advanced nonsquamous non‐small cell lung cancer (NSCLC). Methods Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU‐bevacizumab plus paclitaxel and carboplatin (EU‐bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU‐bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU‐bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75–1.33 (China National Medical Products Administration requirements), or 0.73–1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of −0.12 to 0.15 (EMA requirements). Results In total, 649 randomized patients (BAT1706, n = 325; EU‐bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU‐bevacizumab arms (48.0% and 44.5%, respectively). The ORR18 risk ratio of 1.08 (90% CI: 0.94–1.24) and the ORR18 risk difference of 0.03 (95% CI: −0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU‐bevacizumab. The safety profile of BAT1706 was consistent with that of EU‐bevacizumab and no new safety signals were observed. Conclusion In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU‐bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

Published
2023
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2. Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial.

Author

Glaspy, John, Bondarenko, Igor, Krasnozhon, Dmitrii, Rutty, Dean, Chen, Jianmin, Fu, Yanyan, Wang, Shufang, Hou, Qingsong, and Li, Simon

Subjects
Breast cancer, Efbenmalenograstim alfa, G-CSF, Neutropenia, Humans, Female, Neutrophils, Breast Neoplasms, Docetaxel, Neutropenia, Cyclophosphamide
Abstract

PURPOSE: Evaluate the safety and efficacy of efbemalenograstim alfa for neutrophil support in breast cancer patients undergoing myelosuppressive chemotherapy in a phase 2, dose-finding, open-label study (NCT01648322, ClinicalTrials.gov, 2012-07-19). METHODS: 232 patients received up to 4 cycles of chemotherapy, 141 patients with docetaxel + cyclophosphamide (TC) and 91 patients with docetaxel + doxorubicin + cyclophosphamide (TAC). Patients were randomized to efbemalenograstim alfa (80, 240, or 320 µg/kg [TC]; 240 or 320 µg/kg [TAC]) or pegfilgrastim (6 mg) on Day 2 of each cycle. RESULTS: Efbemalenograstim alfa was non-inferior to pegfilgrastim in duration of moderate and severe neutropenia (absolute neutrophil count [ANC]  2.0 × 109/L after the expected ANC nadir) was 2.0-2.4 and 1.9 days for TAC patients treated with efbemalenograstim alfa and pegfilgrastim, respectively. No significant difference was found between any dose of efbemalenograstim alfa and pegfilgrastim in TAC Cycle 1 for incidence of moderate to severe neutropenia (76%-77% of patients) or incidence of severe neutropenia (ANC

Published
2024

3. Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial.

Author

Bondarenko, Igor, Burdaeva, Olga, Chen, Jianmin, Rutty, Dean, Li, Renshu, Wang, Shufang, Hou, Qingsong, Li, Simon, and Glaspy, John

Subjects
Breast cancer, Docetaxel /doxorubicin therapy, Efbemalenograstim alfa, Febrile neutropenia, Fusion protein, Granulocyte-colony stimulating factor, Female, Humans, Breast Neoplasms, Febrile Neutropenia, Granulocyte Colony-Stimulating Factor, Neutrophils, Recombinant Proteins
Abstract

PURPOSE: Evaluate the safety and efficacy of efbemalenograstim alfa for reducing the risk of febrile neutropenia in breast cancer patients undergoing myelosuppressive chemotherapy. METHODS: A phase III, randomized, double-blind, placebo-controlled study was conducted. A total of 122 subjects received up to 4 cycles of TA chemotherapy (75 mg/m2 docetaxel + 60 mg/m2 doxorubicin). Patients were randomized in a 2:1 ratio to subcutaneously inject a single 20 mg of efbemalenograstim alfa or placebo on day 2 of cycle 1, and all subjects received efbemalenograstim alfa on day 2 of cycles 2, 3, and 4. Duration of severe (grade 4) neutropenia (DSN), depth of neutrophil nadir, incidence of febrile neutropenia (FN), time to neutrophil recovery, and safety information were recorded. RESULTS: For the primary endpoint, the mean DSN in cycle 1 was 1.3 days and 3.9 days for efbemalenograstim alfa and placebo respectively (95% CI, 2.3, 3.4). As the lower bound of the 95% CI was > 0, superiority of efbemalenograstim alfa over placebo can be declared. In addition, the incidence of FN in Cycle 1 was lower in efbemalenograstim alfa group than in placebo group (4.8% vs. 25.6%; p = 0.0016). Patients in the efbemalenograstim alfa group required less intravenous antibiotics (3.6% vs. 17.9%; p = 0.0119). Most adverse events were consistent with those expected for breast cancer patient receiving TA chemotherapy. CONCLUSION: Efbemalenograstim alfa is effective and safe for significantly decreasing the duration of severe neutropenia and the incidence of febrile neutropenia in breast cancer patients who are receiving TA chemotherapy. TRIAL REGISTRATION: NCT02872103, August 19, 2016.

Published
2023

4. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, Zurawski, Bogdan, Spicer, Jonathan D, Garassino, Marina C, Majem, Margarita, Martinengo, Gastón L, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, and Samkari, Ayman

Published
2024
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5. Overall Survival With Palbociclib And Fulvestrant in Women With HR+/HER2- ABC: Updated Exploratory Analyses of PALOMA-3, a Double-Blind, Phase 3 Randomized Study

Author

Cristofanilli, Massimo, Rugo, Hope S, Im, Seock-Ah, Slamon, Dennis J, Harbeck, Nadia, Bondarenko, Igor, Masuda, Norikazu, Colleoni, Marco, DeMichele, Angela, Loi, Sherene, Iwata, Hiroji, O'Leary, Ben, André, Fabrice, Loibl, Sibylle, Bananis, Eustratios, Liu, Yuan, Huang, Xin, Kim, Sindy, Frean, Maria Jose Lechuga, and Turner, Nicholas C

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Breast Cancer, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Double-Blind Method, Female, Fulvestrant, Humans, Piperazines, Pyridines, Receptor, ErbB-2, Receptor, erbB-2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeTo conduct an updated exploratory analysis of overall survival (OS) with a longer median follow-up of 73.3 months and evaluate the prognostic value of molecular analysis by circulating tumor DNA (ctDNA).Patients and methodsPatients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC) were randomized 2:1 to receive palbociclib (125 mg orally/day; 3/1 week schedule) and fulvestrant (500 mg intramuscularly) or placebo and fulvestrant. This OS analysis was performed when 75% of enrolled patients died (393 events in 521 randomized patients). ctDNA analysis was performed among patients who provided consent.ResultsAt the data cutoff (August 17, 2020), 258 and 135 deaths occurred in the palbociclib and placebo groups, respectively. The median OS [95% confidence interval (CI)] was 34.8 months (28.8-39.9) in the palbociclib group and 28.0 months (23.5-33.8) in the placebo group (stratified hazard ratio, 0.81; 95% CI, 0.65-0.99). The 6-year OS rate (95% CI) was 19.1% (14.9-23.7) and 12.9% (8.0-19.1) in the palbociclib and placebo groups, respectively. Favorable OS with palbociclib plus fulvestrant compared with placebo plus fulvestrant was observed in most subgroups, particularly in patients with endocrine-sensitive disease, no prior chemotherapy for ABC and low circulating tumor fraction and regardless of ESR1, PIK3CA, or TP53 mutation status. No new safety signals were identified.ConclusionsThe clinically meaningful improvement in OS associated with palbociclib plus fulvestrant was maintained with >6 years of follow-up in patients with HR+/HER2- ABC, supporting palbociclib plus fulvestrant as a standard of care in these patients.

Published
2022

7. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Azevedo, Sergio, Braghiroli, Maria Ignez, Girotto, Gustavo, Bragagnoli, Arinilda, Branco, Ricardo, Faccio, Adilson, Moretto, Andrea, Skare, Nils, Dutra, Jamille, Viola, Luciana, Vianna, Karina, Meton, Fernando, Sette, Claudia, Faulhaber, Amanda, Tam, Vincent C., Couture, Felix, Biagi, Jim, Castel, Helene, Mulder, Karen, Ko, Yoo-Joung, Zbuk, Kevin, Welch, Stephen, Beaudoin, Annie, Heurgué, Alexandra, Assenat, Eric, Archambeaud, Isabelle, Tougeron, David, Peron, Jean-Marie, Gilabert, Marine, Bronowicki, Jean-Pierre, Cattan, Stephane, Blanc, Jean-Frederic, Bouattour, Mohamed, Phelip, Jean-Marc, Boige, Valerie, Michel, Pierre, Frin, Anne-Claire, De Toni, Enrico N., Berres, Marie-Luise, Vogel, Arndt, Berg, Thomas, Ettrich, Thomas, Waldschmidt, Dirk, Wedemeyer, Hans Heinrich, Worns, Marcus-Alexander, Bitzer, Michael, Weiss, Karl-Heinz, Lau, George, Chan, Stephen L., Yau, Thomas, Tai, Yin Ping, Lee, Ann Shing, Thungappa, Satheesh Chiradoni, N, Lokesh K., Sureshchand Ostwal, Vikas, Ashok, Kattimani Kiran, Mittal, Sushant, Goyal, Hari, Srinivasan, Sankar, Biswas, Ghanashyam, Mohan, Mallavarapu, Limaye, Sewanti, Asarawala, Nirav, Rimassa, Lorenza, Falcone, Alfredo, Gianni, Luca, Gasbarrini, Antonio, Daniele, Bruno, Avallone, Antonio, Paolo Frassineti, Giovanni Luca, Roila, Fausto, Kudo, Masatoshi, Kawaoka, Tomokazu, Morimoto, Manabu, Takikawa, Yasuhiro, Kato, Naoya, Yamashita, Tatsuya, Osaki, Yukio, Motomura, Kenta, Tateishi, Ryosuke, Ohkawa, Kazuyoshi, Wada, Yoshiyuki, Onishi, Hideki, Sasahira, Naoki, Inaba, Yoshitaka, Kurosaki, Masayuki, Tsuji, Kunihiko, Takei, Yoshiyuki, Aramaki, Takeshi, Hagihara, Atsushi, Furuse, Junji, Kioka, Kiyohide, Koga, Hironori, Sasaki, Yutaka, Numata, Kazushi, Tada, Toshifumi, Kawaguchi, Yasunori, Nadano, Seijin, Vasilyev, Alexander, Breder, Valery, Lipatov, Oleg, Dvorkin, Mikhail, Zarubenkov, Oleg, Kutukova, Svetlana, Ponomarev, Roman, Shostka, Kirill, Alyasova, Anna, Topuzov, Eldar, Severtsev, Alexey, Petrov, Yuryi, Erygin, Dmitriy, Berdov, Boris, Kang, Yoon-Koo, Tak, Won-Young, Park, Joong-Won, Lim, Ho Yeong, Heo, Jeong, Kim, Jee Hyun, Kim, Tae-You, Choi, Hye Jin, Varela, María, Reig Monzon, María Elisa, Sangro, Bruno, Martin, Carlos Gómez, Ponce, Carmen Guillén, López, Carlos, Cheng, Ann-Lii, Chao, Yee, Feng, Yin-Hsun, Jeng, Long-Bin, Hung, Chao-Hung, Hou, Ming-Mo, Wang Tsang-En Wang, Jing-Houng, Yen, Chia-Jui, Sukeepaisarnjaroen, Wattana, Sunpaweravong, Patrapim, Charoentum, Chaiyut, Tanasanvimon, Suebpong, Sirachainan, Ekaphop, Ungtrakul, Teerapat, Prasongsook, Naiyarat, Maneenil, Kunlatida, Jitpewngarm, Wittawat, Ostapenko, Yurii, Skoryi, Denys, Bondarenko, Igor, Shparyk, Yaroslav, Trukhin, Dmytro, Hotko, Yevhen, Ursol, Grygorii, Kryzhanivska, Anna, Abou-Alfa, Ghassan K., Mody, Kabir, Dayyani, Farshid, Al-Rajabi, Raed, Yarchoan, Mark, Gandhi, Sunil, Crysler, Oxana, He, Aiwu Ruth, Reeves, James, Bahary, Nathan, Mahipal, Amit, Kelley, Robin Kate, Dasgupta, Anirudha, Rowe, Julie, Thota, Ramya, Beg, Muhammad, Morse, Michael, Choi, Sung-hee, Crocenzi, Todd, Somer, Bradley, Abrams, Thomas, Denlinger, Crystal, Zhang, Yue, Sharma, Nisha, Dao, Tu V., Thinh, Nguyen Tien, Tuyet Phuong, Le Thi, Sangro, B., Chan, S.L., Kelley, R.K., Lau, G., Kudo, M., Sukeepaisarnjaroen, W., Yarchoan, M., De Toni, E.N., Furuse, J., Kang, Y.K., Galle, P.R., Rimassa, L., Heurgué, A., Tam, V.C., Van Dao, T., Thungappa, S.C., Breder, V., Ostapenko, Y., Reig, M., Makowsky, M., Paskow, M.J., Gupta, C., Kurland, J.F., Negro, A., and Abou-Alfa, G.K.

Published
2024
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8. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: cohort 2 of the randomized phase III THOR trial

Author

Bastick, Patricia, Sewak, Sanjeev, Tran, Ben, Pichler, Martin, Shariat, Shahrokh, Rottey, Sylvie, Schatteman, Peter, Schrijvers, Dirk, Verschaeve, Vincent, Vulsteke, Christof, Barros Leite Ferreira, Luiza Aleixo, de Santana Gomes Andrea Juliana, Pereira, Junior, Joao Antonio, Azevedo, Sergio, Bastos, Diogo, Borges, Giuliano, Dettino, Aldo, Antonio, Pires Luis, Luz, Murilo, Martins, Suelen, Mota, Jose Mauricio, Toledo, Joseane, Eigl, Bernhard, Finch, Daygen, Gingerich, Joel, Dong, Haiying, Huang, Jian, Jin, Jie, Pan, Hongming, Sun, Zhongquan, Tian, Ye, Wan, Ben, Wu, Bin, Xu, Ting, Xue, Wei, Zhou, Fangjian, Barthelemy, Philippe, Borchiellini, Delphine, Calcagno, Fabien, Carnot, Aurelien, Cornillon, Pierre, Delva, Remy, Emambux, Sheik, Houede, Nadine, Laguerre, Brigitte, Lauridant, Géraldine, Loriot, Yohann, Mahammedi, Hakim, Maillet, Denis, Pouessel, Damien, Roubaud, Guilhem, Schlurmann-Constans, Friederike, Tosi, Diego, Zanetta, Sylvie, Banek, Severine, Feyerabend, Susan, Kramer, Mario, Niegisch, Guenther, Nuhn, Philipp, Schnabel, Marco, Wuelfing, Christian, Baka, Sofia, Bamias, Aristotelis, Fountzilas, George, Kalofonos, Harabolos, Karalis, Konstantinos, Kotsakis, Athanasios, Timotheadou, Eleni, Landherr, Laszlo, Mangel, Laszlo, Pe’er, Avivit, Levratovsky, Meital, Basso, Umberto, Battelli, Nicola, Cavo, Alessia, De Giorgi, Ugo, Doni, Laura, Galli, Luca, Gigante, Maria Olga, Guadalupi, Valentina, Maio, Michele, Milesi, Laura, Nolè, Franco, Scagliotti, Giorgio, Tortora, Giampaolo, Fukasawa, Satoshi, Harabayashi, Toru, Kamiya, Naoto, Kawahara, Takashi, Kawakita, Mutsushi, Matsubara, Nobunaki, Matsumoto, Kazumasa, Nishimura, Kazuo, Rikiya, Taoka, Shimizu, Nobuaki, Tagaki, Toshio, Kang, Taek Won, Kim, Jwa Hoon, Kim, SeHyun, Lee, Hyo Jin, Lee, Yun-Gyoo, Rha, Sun Young, Seo, Ho Kyung, Los, Maartje, Zurawski, Bogdan, Cortes, Paulo, Faustino, Catia, Vau, Nuno Sineiro, da Luz, Ricardo, Atduev, Vagif, Kirtbaya, Dmitry, Kopyltsov, Evgeny, Lykov, Aleksandr, Marat, Urmantsev, Orlov, Sergey, Penkov, Konstantin, Pirmagomedov, Albert, Semenov, Andrey, Varlamov, Sergey, Anguera, Georgia, Domenech, Montserrat, Girones, Regina, Gonzalez del Alba, Aranzazu, Milagro, Nuria Lainez, Luque, Raquel, Ortega, Esther Martínez, Mellado, Begoña, Méndez Vidal, María Jose, Fernandez, Esteban Nogales, Valderrama, Begoña Perez, Marín, Alvaro Pinto, Santander, Carmen, Huang, Yi-Hsiu, Su, Wen-Pin, Wu, Hung-Chan, Wu, WenJeng, Yu, Kai-Jie, Bilici, Ahmet, Goker, Erdem, Gumus, Mahmut, Karaoglu, Aziz, Kefeli, Umut, Köse, Fatih, Ozguroglu, Mustafa, Tural, Deniz, Turk, Haci, Yalcin, Suayib, Bondarenko, Igor, Khareba, Gennadii, Kidik, Yana, Lychkovskyy, Oleksandr, Sakalo, Valerii, Shevnia, Serghii, Stakhovskyy, Eduard, Bahl, Amit, Crabb, Simon, Powles, Thomas, Sankey, Peter, Sarwar, Mohammad, Benedetto, Pasquale, Burgess, Earle, Dawson, Nancy, Doshi, Gurjyot, Fleming, Mark, Maly, Joseph, Parikh, Mamta, Waterhouse, David, Siefker-Radtke, A.O., Matsubara, N., Park, S.H., Huddart, R.A., Burgess, E.F., Özgüroğlu, M., Valderrama, B.P., Laguerre, B., Basso, U., Triantos, S., Akapame, S., Kean, Y., Deprince, K., Mukhopadhyay, S., and Loriot, Y.

Published
2024
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9. Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Author

Rugo, Hope S, Pennella, Eduardo J, Gopalakrishnan, Unmesh, Hernandez-Bronchud, Miguel, Herson, Jay, Koch, Hans Friedrich, Loganathan, Subramanian, Deodhar, Sarika, Marwah, Ashwani, Manikhas, Alexey, Bondarenko, Igor, Mukhametshina, Guzel, Nemsadze, Gia, Parra, Joseph D, Abesamis-Tiambeng, Maria Luisa T, Baramidze, Kakhaber, Akewanlop, Charuwan, Vynnychenko, Ihor, Sriuranpong, Virote, Mamillapalli, Gopichand, Roy, Sirshendu, Yanez Ruiz, Eduardo Patricio, Barve, Abhijit, Fuentes-Alburo, Adolfo, and Waller, Cornelius F

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Trials and Supportive Activities, Clinical Research, Breast Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Receptor, ErbB-2, Survival Analysis, Trastuzumab, Treatment Outcome, Biosimilar, Metastatic breast cancer, Overall survival, Receptor, erbB-2, Clinical Sciences, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeThe phase 3 HERITAGE trial demonstrated that the biosimilar trastuzumab-dkst is well tolerated with similar efficacy (measured by overall response rate [ORR] and progression-free survival [PFS]) compared with originator trastuzumab combined with taxane followed by monotherapy in patients with HER2-positive metastatic breast cancer (MBC). Herein, we present final overall survival (OS) from HERITAGE.MethodsHERITAGE is a multicenter, double-blind, randomized, parallel-group study. Patients were randomized 1:1 to receive trastuzumab-dkst or trastuzumab plus taxane followed by continued monotherapy until disease progression. Overall survival was to be assessed at 36 months or after 240 deaths, whichever occurred first, as observed from time of randomization of last patient.ResultsAt the final analysis (36 months), 242 patients in the intention-to-treat population had died during the study: 116 and 124 in the trastuzumab-dkst and trastuzumab groups, respectively, and 1 untreated patient from each treatment group. Median OS by Kaplan-Meier analysis was 35.0 months with trastuzumab-dkst and 30.2 months with trastuzumab. Evaluation of PFS showed a median of 11.1 months in both treatment groups. No new safety concerns were reported from week 48 until the end of the survival follow-up.ConclusionThis is the first phase 3 trial of a trastuzumab biosimilar to report long-term survival data similar to originator trastuzumab in patients with MBC. The comparable long-term OS between the trastuzumab-dkst and originator trastuzumab groups further supports the similarity of trastuzumab-dkst with originator trastuzumab and establishes trastuzumab-dkst as a safe and effective treatment option for patients with HER2-positive MBC. ClinicalTrials.gov NCT02472964; 6/16/2015.

Published
2021

10. Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis

Author

Soo, Ross A., Cho, Byoung Chul, Kim, Joo-Hang, Ahn, Myung-Ju, Lee, Ki Hyeong, Zimina, Anastasia, Orlov, Sergey, Bondarenko, Igor, Lee, Yun-Gyoo, Lim, Yueh Ni, Lee, Sung Sook, Lee, Kyung-Hee, Pang, Yong Kek, Fong, Chin Heng, Kang, Jin Hyoung, Lim, Chun Sen, Danchaivijitr, Pongwut, Kilickap, Saadettin, Yang, James Chih-Hsin, Arslan, Cagatay, Lee, Hana, Park, Seong Nam, and Cicin, Irfan

Published
2023
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12. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Author

Mendez, Guillermo, O'Connor, Juan Manuel, Yanzi Castilla, Alvaro, Cundom, Juan, Kaen, Diego, Wong, Rachel, Ng, Weng, Aghmesheh, Morteza, Peressoni, Mauricio, Andrade, Carlos, Franke, Fabio, Alves, Gustavo, Cruz, Felipe Jose, Vianna, Karina, Monteiro, Maria Marcela, Raphael, Michael, Berry, Scott, Jang, Raymond, Tan, Ann, Asselah, Jamil, Yanez Weber, Patricio, Mahave, Mauricio, Sanchez, Cesar, Salman, Pamela, Bai, Yuxian, Li, Jin, Zhang, Xiaochun, Liu, Tianshu, Lin, Xiaoyan, Qin, Shukui, Yang, Jianwei, Luo, Suxia, Li, Wei, Ying, Jieer, Chen, Xi, Zeng, Shan, Qu, Yanli, Yang, Lin, Zhao, Lin, Chen, Ping, Pan, Hongming, Li, Enxiao, Ye, Feng, Lu, Jianwei, Liang, Xinjun, Zhao, Qun, Yin, Xianli, Li, Junhe, Ling, Yang, Lv, Guoqing, Li, Shouguo, Guerrero, Alvaro, Rubiano, Juan, Gonzalez Fernandez, Manuel, Manneh Kopp, Ray, Guzman Ramirez, Adrian, Corrales, Luis, Gonzalez Herrera, Ileana, Melichar, Bohuslav, Buchler, Tomas, Svoboda, Tomas, Obermannova, Radka, Vrana, David, Cvek, Jakub, Pfeiffer, Per, Baeksgaard, Lene, Yilmaz, Mette, Boige, Valerie, Lopez-Trabada, Daniel, Borg, Christophe, Pannier, Diane, Hiret, Sandrine, Di Fiore, Frederic, Metges, Jean-Philippe, Arnold, Dirk, Martens, Uwe, Lordick, Florian, Stein, Alexander, Castro, Hugo, Lopez, Karla, Ramirez, Julio, Aguilar, Mynor, Chivalan, Marco, Chan, Wendy, Cheng, Ashley, Yeo, Winnie, Arkosy, Peter, Csoszi, Tibor, Hitre, Erika, Horvath, Zsolt, Lowery, Maeve, McDermott, Ray, Morris, Patrick, Hubert, Ayala, Brenner, Baruch, Ben-Aharon, Irit, Shacham-Shmueli, Einat, Man, Sofia, Pelles Avraham, Sharon, Brenner, Ronen, Mishaeli, Moshe, Di Bartolomeo, Maria, Fazio, Nicola, Lonardi, Sara, Garufi, Carlo, Satoh, Taroh, Hara, Hiroki, Iwagami, Shiro, Yasui, Hisateru, Tsuda, Masahiro, Shimoyama, Tatsu, Shoji, Hirokazu, Sugimoto, Naotoshi, Shibata, Nobuhiro, Yamaguchi, Kensei, Amagai, Kenji, Choda, Yasuhiro, Esaki, Taito, Yabusaki, Hiroshi, Oshima, Takashi, Tsuji, Akihito, Kawakami, Hisato, Kawazoe, Akihito, Ishido, Kenji, Kadowaki, Shigenori, Martinez Rodriguez, Jorge, Herrera Martinez, Marytere, Huitzil Melendez, Fidel, Ramirez Godinez, Francisco, Balancan, Paola, Damianovich, Dragan, Castro Oliden, Victor, Grados, Julio, Torres, Cesar, Wyrwicz, Lucjan, Wysocki, Piotr, Hajac, Lukasz, Zolnierek, Jakub, Karaszewska, Boguslawa, Rha, Sun Young, Lee, Jeeyun, Ryu, Min-Hee, Oh, Do-Youn, Orlova, Rashida, Tjulandin, Sergey, Fadeeva, Natalia, Makarycheva, Yulia, Nosov, Dmitry, Smagina, Maria, Chan, Sze, Jacobs, Conrad, Kraus, Peter, Landers, Gregory, Robertson, Barbara, Ruff, Paul, Schoeman, Elizabeth, Maurel, Jean-Marc, Diez Garcia, Marc, Jimenez Fonseca, Paula, Gallego Plazas, Javier, Rivera Herrero, Fernando, Miranda Poma, Jesus, Layos Romero, Laura, Fritsch, Ralph, Bastian, Sara, Winterhalder, Ralph, Dosso, Sara De, Kossler, Thibaud, Yeh, Kun-Huei, Yen, Chia-Jui, Chen, Yen-Yang, Lin, Johnson, Bilici, Mehmet, Ozguroglu, Mustafa, Cil, Timucin, Oksuzoglu, Berna, Harputluoglu, Hakan, Karaoglu, Aziz, Hacibekiroglu, Ilhan, Erdogan, Bulent, Yalcin, Suayib, Adamchuk, Hryhoriy, Bondarenko, Igor, Kolesnik, Oleksii, Ostapenko, Yuriy, Kryzhanivska, Anna, Leshchenko, Lurii, Ilin, Ievgen, Shparyk, Yaroslav, Trukhin, Dmytro, Voitko, Nataliia, Roy, Rajarshi, Young, Anna-Mary, Medley, Louise, Shiu, Kai-Keen, Celano, Paul, Overton, Lindsay, Raj, Moses, Dunne, Richard, Wainberg, Zev, Dayyani, Farshid, Larson, Timothy, Kochenderfer, Mark, Yañez, Patricio, Rivera, Fernando, Alves, Gustavo Vasconcelos, Garrido, Marcelo, Fernández, Manuel González, Lowery, Maeve A, Çil, Timuçin, Cruz, Felipe Melo, Wainberg, Zev A, Yin, Lina, Bordia, Sonal, Bhagia, Pooja, and Wyrwicz, Lucjan S

Published
2023
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13. Hybrid palliation versus nonhybrid management for a multi-institutional cohort of infants with critical left heart obstruction

Author

Argo, Madison B., Barron, David J., Bondarenko, Igor, Eckhauser, Aaron, Gruber, Peter J., Lambert, Linda M., Paramananthan, Tharini, Rahman, Maha, Winlaw, David S., Yerebakan, Can, Alsoufi, Bahaaldin, DeCampli, William M., Honjo, Osami, Kirklin, James K., Prospero, Carol, Ramakrishnan, Karthik, St. Louis, James D., Turek, Joseph W., O'Brien, James E., Jr, Pizarro, Christian, Anagnostopoulos, Petros V., Blackstone, Eugene H., Jacobs, Marshall L., Jegatheeswaran, Anusha, Karamlou, Tara, Stephens, Elizabeth H., Polimenakos, Anastasios C., Haw, Marcus P., and McCrindle, Brian W.

Published
2023
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14. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study

Author

Qin, Shukui, Chan, Stephen L, Cheng, Ann-Lii, Kaseb, Ahmed, Vogel, Arndt, Gu, Shanzhi, Bai, Yuxian, Ren, Zhenggang, Lin, Xiaoyan, Chen, Zhendong, Jia, Weidong, Jin, Yongdong, Guo, Yabing, Hu, Xiaohua, Meng, Zhiqiang, Liang, Jun, Cheng, Ying, Xiong, Jianping, Ren, Hong, Yang, Fang, Li, Wei, Chen, Yajin, Zeng, Yong, Sultanbaev, Alexander, Pazgan-Simon, Monika, Pisetska, Margaryta, Melisi, Davide, Ponomarenko, Dmitriy, Osypchuk, Yurii, Sinielnikov, Ivan, Yang, Tsai-Sheng, Liang, Xiao, Chen, Chunxia, Wang, Linna, Zhang, Mingxiang, Xu, Li, Yuan, Xianglin, Li, Da, Ying, Jierer, Zhang, Jingdong, Zhang, Tao, Gu, Kangsheng, He, Yifu, Hao, Ping, Jiang, Da, Zhang, Shu, Xing, Baocai, Zhang, Baihong, Wang, Dong, Zhai, Xiaofeng, Liang, Houjie, Cybulska-Stopa, Bozena, Dvorkin, Mikhail, Stroyakovskiy, Daniil, Nechaeva, Marina, Yen, Chia-Jui, Su, Wei-Wen, Chen, Yen-Hao, Bondarenko, Igor, Yang, Lin, Fang, Weijia, Gomez-Martin, Carlos, Ryu, Min-Hee, Kim, Han-Sang, Kim, Jee-Hyun, Zarubenkov, Oleg, Orlova, Rashida, Poddubskaya, Elena, Fadeeva, Natalia, Makarova, Yulia, Chao, Yee, Hung, Chao-Hung, Neffa, Maryna, Vynnychenko, Oleksandr, Burgoyne, Adam, Hao, Chunyi, Mohr, Raphael U, Diaz-Beveridge, Roberto, Feliu-Batlle, Jaime, Cubillo-Gracian, Antonio, Lee, Ann-Shing, Daniele, Bruno, Antonuzzo, Lorenzo, Sangiovanni, Angelo, Gasbarrini, Antonio, Scartozzi, Mario, Ahn, Mi Sun, Oh, Sung-Yong, Orlov, Sergey, Harputluoglu, Hakan, Oksuzoglu, Berna, Hsu, Chiun, Rau, Kun-Ming, Krechkovskyi, Oleksandr, Yareshko, Vladimir, Xiong, Henry, Lee, Fa-Chyi, Jiang, Yixing, Gabayan, Afshin, Crow, Mary, Van Steenkiste, Christophe, and Verset, Gontran

Published
2023
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15. First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial

Author

Özgüroğlu, Mustafa, Kilickap, Saadettin, Sezer, Ahmet, Gümüş, Mahmut, Bondarenko, Igor, Gogishvili, Miranda, Nechaeva, Marina, Schenker, Michael, Cicin, Irfan, Ho, Gwo Fuang, Kulyaba, Yaroslav, Zyuhal, Kasimova, Scheusan, Roxana-Ioana, Garassino, Marina Chiara, He, Xuanyao, Kaul, Manika, Okoye, Emmanuel, Li, Yuntong, Li, Siyu, Pouliot, Jean-Francois, Seebach, Frank, Lowy, Israel, Gullo, Giuseppe, and Rietschel, Petra

Published
2023
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17. Rucaparib versus standard-of-care chemotherapy in patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation (ARIEL4): an international, open-label, randomised, phase 3 trial

Author

Kristeleit, Rebecca, Lisyanskaya, Alla, Fedenko, Alexander, Dvorkin, Mikhail, de Melo, Andreia Cristina, Shparyk, Yaroslav, Rakhmatullina, Irina, Bondarenko, Igor, Colombo, Nicoletta, Svintsitskiy, Valentyn, Biela, Luciano, Nechaeva, Marina, Lorusso, Domenica, Scambia, Giovanni, Cibula, David, Póka, Róbert, Oaknin, Ana, Safra, Tamar, Mackowiak-Matejczyk, Beata, Ma, Ling, Thomas, Daleen, Lin, Kevin K, McLachlan, Karen, Goble, Sandra, and Oza, Amit M

Published
2022
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18. Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies.

Author

Penkov, Konstantin, Bondarenko, Igor, Saenko, Daria Viktorovna, Kulyaba, Yaroslav, Guo, Jun, Gong, Yi, Yamamoto, Noboru, Hotko, Yevhen Stepanovych, Boyko, Vasyl, Fadeeva, Natalya Vladimirovna, Ursol, Grygorii Mykolaiovych, Ahn, Hee Kyung, Kislov, Nikolay Viktorovich, Shen, Chia-I, Davis, Craig, Kowalski, Karey, Michelon, Elisabete, Pavlov, Dmitri, Hirohashi, Tomoko, and Cho, Byoung Chul

Abstract

Background: Sasanlimab (PF-06801591), a humanized immunoglobulin G4 monoclonal antibody, binds to programmed cell death protein-1 (PD-1), preventing ligand (PD-L1) interaction. Objectives: To evaluate pharmacokinetics (PK), safety, tolerability, and efficacy of two subcutaneous sasanlimab dosing regimens. Design: An open-label study consisting of phases Ib and II. Phase Ib: non-randomized, dose escalation, and expansion study in Asian participants with advanced malignancies. Phase II: conducted globally in participants with non-small-cell lung cancer with PD-L1 positive or PD-L1 status unknown tumors; participants were randomized 1:2 to receive subcutaneous sasanlimab 300 mg once every 4 weeks (300 mg-Q4W) or 600 mg once every 6 weeks (600 mg-Q6W). Methods: Primary endpoint in phase Ib: dose-limiting toxicity (DLT) occurring in first treatment cycle; in phase II: C trough and AUC. Results: A total of 155 participants (phase Ib, n = 34; phase II, n = 121) received sasanlimab. Phase Ib: no DLT reported. Phase II: ratio of adjusted geometric mean for AUCtau was 231.2 (90% CI, 190.1–281.2) and C trough was 111.5 (90% CI, 86.3–144.0) following 600 mg-Q6W (test) versus 300 mg-Q4W (reference). Phase Ib: grade 3 treatment-related adverse events (TRAEs) occurred in 1/4 (25%) and 3/12 (25%) participants treated in 300 mg-Q4W dose escalation and expansion cohorts, respectively. Phase II: grade 3 TRAEs occurred in 3/41 (7.3%) and 3/80 (3.8%) participants treated with 300 mg-Q4W and 600 mg-Q6W, respectively; no grade 4/5 TRAEs. Phase II: confirmed objective response was observed in 11/41 (26.8% (95% CI, 14.2–42.9)) and 12/80 (15.0% (95% CI, 8.0–24.7)) participants treated with 300 mg-Q4W and 600 mg-Q6W, respectively. Conclusions: Phase Ib regimens were considered safe with no DLTs reported. In phase II, 600 mg-Q6W regimen criteria were met for AUCtau and C trough metrics to support PK-based extrapolation of efficacy of alternative regimen. Regimens were well tolerated, showing anti-tumor activity in participants with advanced solid tumors. Administration of sasanlimab at a dose of 600 mg-Q6W subcutaneously may serve as a convenient alternative to 300 mg-Q4W administration. Trial registration: NCT04181788 (ClinicalTrials.gov); 2019-003818-14 (EudraCT). [ABSTRACT FROM AUTHOR]

Published
2024
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19. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial

Author

Turner, Nicholas, Dent, Rebecca A., O’Shaughnessy, Joyce, Kim, Sung-Bae, Isakoff, Steven J., Barrios, Carlos, Saji, Shigehira, Bondarenko, Igor, Nowecki, Zbigniew, Lian, Qinshu, Reilly, Sarah-Jayne, Hinton, Heather, Wongchenko, Matthew J., Kovic, Bruno, Mani, Aruna, and Oliveira, Mafalda

Published
2022
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21. Alectinib in Resected ALK -Positive Non–Small-Cell Lung Cancer

Author

Wu, Yi-Long, primary, Dziadziuszko, Rafal, additional, Ahn, Jin Seok, additional, Barlesi, Fabrice, additional, Nishio, Makoto, additional, Lee, Dae Ho, additional, Lee, Jong-Seok, additional, Zhong, Wenzhao, additional, Horinouchi, Hidehito, additional, Mao, Weimin, additional, Hochmair, Maximilian, additional, de Marinis, Filippo, additional, Migliorino, M. Rita, additional, Bondarenko, Igor, additional, Lu, Shun, additional, Wang, Qun, additional, Ochi Lohmann, Tania, additional, Xu, Tingting, additional, Cardona, Andres, additional, Ruf, Thorsten, additional, Noe, Johannes, additional, and Solomon, Benjamin J., additional

Published
2024
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23. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Matasar, Matthew J, Capra, Marcelo, Özcan, Muhit, Lv, Fangfang, Li, Wei, Yañez, Eduardo, Sapunarova, Katya, Lin, Tongyu, Jin, Jie, Jurczak, Wojciech, Hamed, Aryan, Wang, Ming-Chung, Baker, Ross, Bondarenko, Igor, Zhang, Qingyuan, Feng, Jifeng, Geissler, Klaus, Lazaroiu, Mihaela, Saydam, Guray, Szomor, Árpád, Bouabdallah, Krimo, Galiulin, Rinat, Uchida, Toshiki, Soler, Lidia Mongay, Cao, Anjun, Hiemeyer, Florian, Mehra, Aruna, Childs, Barrett H, Shi, Yuankai, and Zinzani, Pier Luigi

Published
2021
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24. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Spicer, Jonathan D, Garassino, Marina C, Wakelee, Heather, Liberman, Moishe, Kato, Terufumi, Tsuboi, Masahiro, Lee, Se-Hoon, Chen, Ke-Neng, Dooms, Christophe, Majem, Margarita, Eigendorff, Ekkehard, Martinengo, Gastón L, Bylicki, Olivier, Rodríguez-Abreu, Delvys, Chaft, Jamie E, Novello, Silvia, Yang, Jing, Arunachalam, Ashwini, Keller, Steven M, Samkari, Ayman, Gao, Shugeng, Afanasyev, Sergey, Ahmed, Samreen, Alekshun, Todd, Alves, Gustavo, Anderson, Ian, Araujo, Luiz Henrique, Arkhipov, Alexander, Arora, Arvind, Bai, Jie, Begin, Paul, Belonogov, Aleksandr, Berard, Henri, Berceanu-Ion, Radu, Bernabe Caro, Reyes, Bondarenko, Igor, Bonnet, Reiner, Bosch Barrera, Joaquim, Brocca, Carlos, Bryl, Maciej, Bulotta, Alessandra, Bylicki, Olivier, Calles Blanco, Antonio, Carcereny, Enric, Carvalho, Leticia, Cebotaru, Cristina, Chaft, Jamie, Charu, Veena, Chaves, Fabio, Chen, Jun, Chen, Ke-Neng, Chen, Haiquan, Chen, Qixun, Chen, Kevin, Chiang, Chi-Lu, Chiu, Chao-Hua, Cicenas, Saulius, Ciubotaru, Elena, Ciuleanu, Tudor, Ciurescu, Ioana, Cobb, Patrick, Coetzee, Corlia, Collins, Dearbhaile, Cortinovis, Diego, Costas, Kimberly, Costin, Dan, Cronemberger, Eduardo Henrique, Cuevo, Raymund, Cuffe, Sinead, De Marchi, Pedro Rafael Martins, de Paiva Junior, Tadeu, Delmonte, Angelo, Demedts, Ingel, Deschepper, Koenraad, Dias, Josiane, Dooms, Christophe, Duchemann, Boris, Dutra, Carolina, Duvivier, Herbert, Eigendorff, Ekkehard, Ernani, Vinicius, Faehling, Martin, Faria, Luiza, Fedenko, Alexander, Fernando, Hiran, Ferrara, Roberto, Ferrari, Vittorio, Finley, Gene, Fix, Peter, Flores, Marcos, Fourie, Samuel, Franke, Fabio, Frohling, Klaus-Peter, Furqan, Muhammad, Gal, Cristian, Galamaga, Robert, Ganea, Doina, Ganti, Apar Kishor, Gao, Shugeng, Garassino, Marina, Gentzler, Ryan, Gianni, Luca, Gilli, Marina, Girard, Nicolas, Goranov, Bojidar, Gregorc, Vanesa, Greystoke, Alastair, Grisanti, Salvatore, Grohe, Christian, Guarino, Michael, Guimaraes, Jose Luiz, Guisier, Florian, Halmos, Balazs, Hammoud, Zane Taysir, Han, Ji-Youn, Hegmane, Alinta, Heng, Fook Yew, Horinouchi, Hidehito, Horio, Yoshitsugu, Hu, Jian, Huang, Hsu-Ching, Hui, Rina, Ikeda, Norihiko, Intagliata, Salvatore, Iordan, Ingrid, Jacobs, Conrad, Jain, Kirti, Jain, Sushil, Jiang, Tao, Karaseva, Nina, Kato, Terufumi, Kaywin, Paul, Kazmi, Shayma, Keresztes, Roger, Khan, Sarah, Kim, Jhingook, Kolesnik, Olena, Kolesnik, Oleksii, Kollmeier, Jens, Komiya, Takefumi, Koontz, Michael, Krasnohrud, Yuliia, Kristedja, Timothy, Kryzhanivska, Anna, Kuroda, Hiroaki, Laktionov, Konstantin, Lambrechts, Marc, Lang, Susanne, Langleben, Adrian, Lee, Se-Hoon, Lehmann, Markus, Levchenko, Evgeny, Levenko, Oleh, Li, Shanqing, Liao, Bin-Chi, Liberman, Moishe, Lima, Iane, Liu, Geoffrey, Liu-Dumlao, Theresa, Lo Russo, Giuseppe, Lou, Yan Yan, Lowczak, Anna, Luft, Alexander, Ma, Shaohua, Majem Tarruella, Margarita, Makles, Krytsyna, Martinengo, Gaston, Martinez Marti, Alex, Matias, Danielli, Mazieres, Julien, Mazilu, Laura, Mennecier, Bertrand, Migliorino, Maria Rita, Misleh, Jamal, Molina, Julian, Morbeck, Igor, Mueller, Annette, Muto, Satoshi, Nadal Alforja, Ernest, Nesterova, Alfiya, Nishio, Wataru, Niu, Jiaxin, Novello, Silvia, O'Brien, Mary, O'Day, Steven, Ogliari, Francesca, Okada, Morihito, Pang, Yong Kek, Paramonov, Viktor, Pastor, Andrea, Pawlak, Ireneusz, Piantedosi, Francovito, Pollock, Theodore, Pope, Tony, Puig, Juan, Radhi, Saba, Rao, Suman, Rathnasabapathy, Chenthilmurugan, Reck, Martin, Reinacher-Schick, Anke, Rich, Patricia, Ritgen, Mathias, Rittmeyer, Achim, Roca, Elisa, Rodriguez-Abreu, Delvys, Ruff, Paul, Rybkin, Igor, Saji, Hisashi, Sakao, Yukinori, Sangal, Ashish, Santoro, Armando, Sardenberg, Rodrigo, Savvides, Panayiotis, Scheusan, Roxana, Schiller, Joan, Schumacher, Lana, Serke, Monika, Shim, Byoung Yong, Shimizu, Junichi, Shio, Yutaka, Sibille, Anne, Siegel, Robert, Signorelli, Diego, Smagina, Maria, Sokur, Iryna, Spicer, Jonathan, Srkalovic, Gordan, Stampleman, Laura, Starodub, Alexander, Stencel, Katarzyna, Sugio, Kenji, Surmont, Veerle, Suzuki, Hiroyuki, Tabacof, Jacques, Takamochi, Kazuya, Tan, Lijie, Tanaka, Fumihiro, Tatangelo, Marcelo, Täuscher, Dagmar, Teixeira, Carlos, Thiberville, Luc, Trukhin, Dmytro, Tsai, Chen-Liang, Tsuboi, Masahiro, Ungureanu, Andrei, Ursol, Grygorii, Vanakesa, Tonu, Vansteenkiste, Johan, Varela, Mirta, Villalona-Calero, Miguel, Villaruz, Liza, Vogel, Gunther, Voitko, Nataliia, Wakelee, Heather, Wang, Qun, Wang, Wenxiang, Wang, Chin-Chou, Wang, Sarah, Wehler, Thomas, Weksler, Benny, Wermke, Martin, Wesseler, Claas, Wirtz, Hubert, Wong, Mark, Yan, Xiaolong, Yang, Yue, Yu, Kong Leong, Zasadny, Xavier, Zemaitis, Marius, Zhang, Lanjun, Zhao, Guofang, Zhao, Qing, Zhu, Yuming, and Zurawski, Bogdan

Abstract

At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.

Published
2024
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25. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Diéras, Véronique, Han, Hyo S, Kaufman, Bella, Wildiers, Hans, Friedlander, Michael, Ayoub, Jean-Pierre, Puhalla, Shannon L, Bondarenko, Igor, Campone, Mario, Jakobsen, Erik H, Jalving, Mathilde, Oprean, Cristina, Palácová, Marketa, Park, Yeon Hee, Shparyk, Yaroslav, Yañez, Eduardo, Khandelwal, Nikhil, Kundu, Madan G, Dudley, Matthew, Ratajczak, Christine K, Maag, David, and Arun, Banu K

Published
2020
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26. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial

Author

Wong, Suet-Lai Shirley, Tan, Thean Hsiang, Hovey, Elizabeth Jane, Clay, Timothy Dudley, Wan Ng, Siobhan Su, Rutten, Annemie, Machiels, Jean-Pascal, Dumez, Herlinde, Cheng, Susanna Yee-Shan, Ferrario, Cristiano, Sengeloev, Lisa, Jensen, Niels Viggo, Thibault, Constance, Laguerre, Brigitte, Joly, Florence, Culine, Stéphane, Becht, Catherine, Niegisch, Günter, Stöckle, Michael, Grimm, Marc-Oliver, Schwentner, Christina A, Schultze-Seemann, Wolfgang, Kalofonos, Haralambos, Mavroudis, Dimitrios, Papandreou, Christos, Karavasilis, Vasilis, Révész, Janos, Rosenbaum, Eli, Leibowitz-Amit, Raya, Kejzman, Daniel, Sarid, David, Scagliotti, Giorgio Vittorio, Bracarda, Sergio, Massari, Francesco, Osawa, Takahiro, Miyajima, Naoto, Shinohara, Nobuo, Fukuta, Fumimasa, Ohyama, Chikara, Obara, Wataru, Yamashita, Shinichi, Tomita, Yoshihiko, Kawai, Koji, Fukasawa, Satoshi, Oyama, Masafumi, Yonese, Junji, Nagata, Masayoshi, Uemura, Motohide, Nishimura, Kazuo, Kawakita, Mutsushi, Tsunemori, Hiroyuki, Hashine, Katsuyoshi, Inokuchi, Junichi, Yokomizo, Akira, Nagamori, Satoshi, Lee, Hyo Jin, Park, Se Hoon, Rha, Sun Young, Kim, Yu Jung, Lee, Yun-Gyoo, Vazquez Cortés, Leticia, Lorena Urzua Flores, Claudia, Blaisse, Reinoud J.B., Erdkamp, Fransiscus L.G., Aarts, Maureen J.B., Wojcik-Tomaszewska, Joanna, Tomczak, Piotr, Sikora-Kupis, Bozena, Schenker, Michael, Herzal, Alina Amalia, Udrea, Anghel Adrian, Karlov, Petr, Fomkin, Roman, Gajate Borau, Pablo, Grande, Enrique, Delgado Mignorance, Juan Ignacio, Su, Yu-Li, Li, Jian-Ri, Lin, Chien-Liang, Lin, Chia-Chi, Yeh, Su-Peng, Erman, Mustafa, Urun, Yuksel, Golovko, Yuriy, Bondarenko, Igor, Sinielnikov, Ivan, Crabb, Simon J., Syndikus, Isabel, Huddart, Robert, Sundar, Santhanam, Chowdhury, Simon, Sarwar, Naveed, Flaig, Thomas W., Pan, Chong Xian, Schwarz, James K., Cultrera, Jennifer Lyn, Acs, Peter Istvan, Hainsworth, John D., Herms, Benjamin T., Lawler, William Eyre, Lowe, Thomas Eugene, Petrylak, Daniel P, de Wit, Ronald, Chi, Kim N, Drakaki, Alexandra, Sternberg, Cora N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan Y, van der Heijden, Michiel S, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan Senol, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor J, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Hamid, Oday, Liepa, Astra M, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard A, Zimmermann, Annamaria H, Hozak, Rebecca R, Bell-McGuinn, Katherine M, and Powles, Thomas

Published
2020
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27. Data from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Author

Paz-Ares, Luis, primary, Garassino, Marina Chiara, primary, Chen, Yuanbin, primary, Reinmuth, Niels, primary, Hotta, Katsuyuki, primary, Poltoratskiy, Artem, primary, Trukhin, Dmytro, primary, Hochmair, Maximilian J., primary, Özgüroğlu, Mustafa, primary, Ji, Jun Ho, primary, Statsenko, Galina, primary, Conev, Nikolay, primary, Bondarenko, Igor, primary, Havel, Libor, primary, Losonczy, György, primary, Xie, Mingchao, primary, Lai, Zhongwu, primary, Godin-Heymann, Nadia, primary, Mann, Helen, primary, Jiang, Haiyi, primary, Shrestha, Yashaswi, primary, and Goldman, Jonathan W., primary

Published
2024
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28. Supplementary Figure S11 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Author

Paz-Ares, Luis, primary, Garassino, Marina Chiara, primary, Chen, Yuanbin, primary, Reinmuth, Niels, primary, Hotta, Katsuyuki, primary, Poltoratskiy, Artem, primary, Trukhin, Dmytro, primary, Hochmair, Maximilian J., primary, Özgüroğlu, Mustafa, primary, Ji, Jun Ho, primary, Statsenko, Galina, primary, Conev, Nikolay, primary, Bondarenko, Igor, primary, Havel, Libor, primary, Losonczy, György, primary, Xie, Mingchao, primary, Lai, Zhongwu, primary, Godin-Heymann, Nadia, primary, Mann, Helen, primary, Jiang, Haiyi, primary, Shrestha, Yashaswi, primary, and Goldman, Jonathan W., primary

Published
2024
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29. Supplementary Table S3 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Author

Paz-Ares, Luis, primary, Garassino, Marina Chiara, primary, Chen, Yuanbin, primary, Reinmuth, Niels, primary, Hotta, Katsuyuki, primary, Poltoratskiy, Artem, primary, Trukhin, Dmytro, primary, Hochmair, Maximilian J., primary, Özgüroğlu, Mustafa, primary, Ji, Jun Ho, primary, Statsenko, Galina, primary, Conev, Nikolay, primary, Bondarenko, Igor, primary, Havel, Libor, primary, Losonczy, György, primary, Xie, Mingchao, primary, Lai, Zhongwu, primary, Godin-Heymann, Nadia, primary, Mann, Helen, primary, Jiang, Haiyi, primary, Shrestha, Yashaswi, primary, and Goldman, Jonathan W., primary

Published
2024
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30. Data from First-Line Ipatasertib, Atezolizumab, and Taxane Triplet for Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Results

Author

Schmid, Peter, primary, Turner, Nicholas C., primary, Barrios, Carlos H., primary, Isakoff, Steven J., primary, Kim, Sung-Bae, primary, Sablin, Marie-Paule, primary, Saji, Shigehira, primary, Savas, Peter, primary, Vidal, Gregory A., primary, Oliveira, Mafalda, primary, O'Shaughnessy, Joyce, primary, Italiano, Antoine, primary, Espinosa, Enrique, primary, Boni, Valentina, primary, White, Shane, primary, Rojas, Beatriz, primary, Freitas-Junior, Ruffo, primary, Chae, Yeesoo, primary, Bondarenko, Igor, primary, Lee, Jieun, primary, Torres Mattos, Cesar, primary, Martinez Rodriguez, Jorge Luis, primary, Lam, Lisa H., primary, Jones, Surai, primary, Reilly, Sarah-Jayne, primary, Huang, Xiayu, primary, Shah, Kalpit, primary, and Dent, Rebecca, primary

Published
2024
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31. Supplementary Tables and Figures 1 from First-Line Ipatasertib, Atezolizumab, and Taxane Triplet for Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Results

Author

Schmid, Peter, primary, Turner, Nicholas C., primary, Barrios, Carlos H., primary, Isakoff, Steven J., primary, Kim, Sung-Bae, primary, Sablin, Marie-Paule, primary, Saji, Shigehira, primary, Savas, Peter, primary, Vidal, Gregory A., primary, Oliveira, Mafalda, primary, O'Shaughnessy, Joyce, primary, Italiano, Antoine, primary, Espinosa, Enrique, primary, Boni, Valentina, primary, White, Shane, primary, Rojas, Beatriz, primary, Freitas-Junior, Ruffo, primary, Chae, Yeesoo, primary, Bondarenko, Igor, primary, Lee, Jieun, primary, Torres Mattos, Cesar, primary, Martinez Rodriguez, Jorge Luis, primary, Lam, Lisa H., primary, Jones, Surai, primary, Reilly, Sarah-Jayne, primary, Huang, Xiayu, primary, Shah, Kalpit, primary, and Dent, Rebecca, primary

Published
2024
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32. Supplementary Material S1 from Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Author

Paz-Ares, Luis, primary, Garassino, Marina Chiara, primary, Chen, Yuanbin, primary, Reinmuth, Niels, primary, Hotta, Katsuyuki, primary, Poltoratskiy, Artem, primary, Trukhin, Dmytro, primary, Hochmair, Maximilian J., primary, Özgüroğlu, Mustafa, primary, Ji, Jun Ho, primary, Statsenko, Galina, primary, Conev, Nikolay, primary, Bondarenko, Igor, primary, Havel, Libor, primary, Losonczy, György, primary, Xie, Mingchao, primary, Lai, Zhongwu, primary, Godin-Heymann, Nadia, primary, Mann, Helen, primary, Jiang, Haiyi, primary, Shrestha, Yashaswi, primary, and Goldman, Jonathan W., primary

Published
2024
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33. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Sangro, B., primary, Chan, S.L., additional, Kelley, R.K., additional, Lau, G., additional, Kudo, M., additional, Sukeepaisarnjaroen, W., additional, Yarchoan, M., additional, De Toni, E.N., additional, Furuse, J., additional, Kang, Y.K., additional, Galle, P.R., additional, Rimassa, L., additional, Heurgué, A., additional, Tam, V.C., additional, Van Dao, T., additional, Thungappa, S.C., additional, Breder, V., additional, Ostapenko, Y., additional, Reig, M., additional, Makowsky, M., additional, Paskow, M.J., additional, Gupta, C., additional, Kurland, J.F., additional, Negro, A., additional, Abou-Alfa, G.K., additional, Azevedo, Sergio, additional, Braghiroli, Maria Ignez, additional, Girotto, Gustavo, additional, Bragagnoli, Arinilda, additional, Branco, Ricardo, additional, Faccio, Adilson, additional, Moretto, Andrea, additional, Skare, Nils, additional, Dutra, Jamille, additional, Viola, Luciana, additional, Vianna, Karina, additional, Meton, Fernando, additional, Sette, Claudia, additional, Faulhaber, Amanda, additional, Tam, Vincent C., additional, Couture, Felix, additional, Biagi, Jim, additional, Castel, Helene, additional, Mulder, Karen, additional, Ko, Yoo-Joung, additional, Zbuk, Kevin, additional, Welch, Stephen, additional, Beaudoin, Annie, additional, Heurgué, Alexandra, additional, Assenat, Eric, additional, Archambeaud, Isabelle, additional, Tougeron, David, additional, Peron, Jean-Marie, additional, Gilabert, Marine, additional, Bronowicki, Jean-Pierre, additional, Cattan, Stephane, additional, Blanc, Jean-Frederic, additional, Bouattour, Mohamed, additional, Phelip, Jean-Marc, additional, Boige, Valerie, additional, Michel, Pierre, additional, Frin, Anne-Claire, additional, Enrico N De Toni, Germany, additional, Berres, Marie-Luise, additional, Vogel, Arndt, additional, Berg, Thomas, additional, Ettrich, Thomas, additional, Waldschmidt, Dirk, additional, Wedemeyer, Hans Heinrich, additional, Worns, Marcus-Alexander, additional, Bitzer, Michael, additional, Weiss, Karl-Heinz, additional, Lau, George, additional, Chan, Stephen L., additional, Yau, Thomas, additional, Tai, Yin Ping, additional, Lee, Ann Shing, additional, Thungappa, Satheesh Chiradoni, additional, N, Lokesh K., additional, Ostwal, Vikas Sureshchand, additional, Ashok, Kattimani Kiran, additional, Mittal, Sushant, additional, Goyal, Hari, additional, Srinivasan, Sankar, additional, Biswas, Ghanashyam, additional, Mohan, Mallavarapu, additional, Limaye, Sewanti, additional, Asarawala, Nirav, additional, Rimassa, Lorenza, additional, Falcone, Alfredo, additional, Gianni, Luca, additional, Gasbarrini, Antonio, additional, Daniele, Bruno, additional, Avallone, Antonio, additional, Paolo Frassineti, Giovanni Luca, additional, Roila, Fausto, additional, Kudo, Masatoshi, additional, Kawaoka, Tomokazu, additional, Morimoto, Manabu, additional, Takikawa, Yasuhiro, additional, Kato, Naoya, additional, Yamashita, Tatsuya, additional, Osaki, Yukio, additional, Motomura, Kenta, additional, Tateishi, Ryosuke, additional, Ohkawa, Kazuyoshi, additional, Wada, Yoshiyuki, additional, Onishi, Hideki, additional, Sasahira, Naoki, additional, Inaba, Yoshitaka, additional, Kurosaki, Masayuki, additional, Tsuji, Kunihiko, additional, Takei, Yoshiyuki, additional, Aramaki, Takeshi, additional, Hagihara, Atsushi, additional, Furuse, Junji, additional, Kioka, Kiyohide, additional, Koga, Hironori, additional, Sasaki, Yutaka, additional, Numata, Kazushi, additional, Tada, Toshifumi, additional, Kawaguchi, Yasunori, additional, Nadano, Seijin, additional, Alexander Vasilyev, Russian Federation, additional, Breder, Valery, additional, Lipatov, Oleg, additional, Dvorkin, Mikhail, additional, Zarubenkov, Oleg, additional, Kutukova, Svetlana, additional, Ponomarev, Roman, additional, Shostka, Kirill, additional, Alyasova, Anna, additional, Topuzov, Eldar, additional, Severtsev, Alexey, additional, Petrov, Yuryi, additional, Erygin, Dmitriy, additional, Berdov, Boris, additional, Kang, Yoon-Koo, additional, Tak, Won-Young, additional, Park, Joong-Won, additional, Lim, Ho Yeong, additional, Heo, Jeong, additional, Kim, Jee Hyun, additional, Kim, Tae-You, additional, Choi, Hye Jin, additional, Varela, María, additional, Reig Monzon, María Elisa, additional, Sangro, Bruno, additional, Martin, Carlos Gómez, additional, Ponce, Carmen Guillén, additional, López, Carlos, additional, Cheng, Ann-Lii, additional, Chao, Yee, additional, Feng, Yin-Hsun, additional, Jeng, Long-Bin, additional, Hung, Chao-Hung, additional, Hou, Ming-Mo, additional, Wang Tsang-En Wang, Jing-Houng, additional, Yen, Chia-Jui, additional, Sukeepaisarnjaroen, Wattana, additional, Sunpaweravong, Patrapim, additional, Charoentum, Chaiyut, additional, Tanasanvimon, Suebpong, additional, Sirachainan, Ekaphop, additional, Ungtrakul, Teerapat, additional, Prasongsook, Naiyarat, additional, Maneenil, Kunlatida, additional, Jitpewngarm, Wittawat, additional, Ostapenko, Yurii, additional, Skoryi, Denys, additional, Bondarenko, Igor, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Hotko, Yevhen, additional, Ursol, Grygorii, additional, Kryzhanivska, Anna, additional, Abou-Alfa, Ghassan K., additional, Mody, Kabir, additional, Dayyani, Farshid, additional, Al-Rajabi, Raed, additional, Yarchoan, Mark, additional, Gandhi, Sunil, additional, Crysler, Oxana, additional, He, Aiwu Ruth, additional, Reeves, James, additional, Bahary, Nathan, additional, Mahipal, Amit, additional, Kelley, Robin Kate, additional, Dasgupta, Anirudha, additional, Rowe, Julie, additional, Thota, Ramya, additional, Beg, Muhammad, additional, Morse, Michael, additional, Choi, Sung-hee, additional, Crocenzi, Todd, additional, Somer, Bradley, additional, Abrams, Thomas, additional, Denlinger, Crystal, additional, Zhang, Yue, additional, Sharma, Nisha, additional, Dao, Tu V., additional, Thinh, Nguyen Tien, additional, and Tuyet Phuong, Le Thi, additional

Published
2024
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34. Efficacy and safety of trifluridine/tipiracil in combination with bevacizumab in older and younger patients with refractory metastatic colorectal cancer: A subgroup analysis of the phase 3 SUNLIGHT trial.

Author

Taieb, Julien, primary, Prager, Gerald W., additional, Fakih, Marwan, additional, Ciardello, Fortunato, additional, Van Cutsem, Eric, additional, Elez, Elena, additional, Cruz, Felipe Melo, additional, Wyrwicz, Lucjan S., additional, Stroyakovskiy, Daniil, additional, Papai, Zsuzsanna, additional, Poureau, Pierre-Guillaume, additional, Liposits, Gabor, additional, Cremolini, Chiara, additional, Bondarenko, Igor, additional, Modest, Dominik Paul, additional, Roby, Lucas, additional, Barboux, Valentine, additional, Amellal, Nadia, additional, and Tabernero, Josep, additional

Published
2024
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35. First-Line Ipatasertib, Atezolizumab, and Taxane Triplet for Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Results

Author

Schmid, Peter, primary, Turner, Nicholas C., additional, Barrios, Carlos H., additional, Isakoff, Steven Jay., additional, Kim, Sung-Bae, additional, Sablin, Marie-Paule, additional, Saji, Shigehira, additional, Savas, Peter, additional, Vidal, Gregory A., additional, Oliveira, Mafalda, additional, O’Shaughnessy, Joyce, additional, Italiano, Antoine, additional, Espinosa, Enrique, additional, Boni, Valentina, additional, White, Shane, additional, Rojas, Beatriz, additional, Freitas-Junior, Ruffo, additional, Chae, Yeesoo, additional, Bondarenko, Igor, additional, Lee, Jieun, additional, Torres Mattos, Cesar, additional, Martinez Rodriguez, Jorge Luis., additional, Lam, Lisa, additional, Jones, Surai, additional, Reilly, Sarah-Jayne, additional, Huang, Xiayu, additional, Shah, Kalpit, additional, and Dent, Rebecca, additional

Published
2023
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37. Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first-line treatment of ER+/HER2− advanced breast cancer (PALOMA-1, TRIO-18)

Author

Finn, Richard S., Boer, Katalin, Bondarenko, Igor, Patel, Ravindranath, Pinter, Tamas, Schmidt, Marcus, Shparyk, Yaroslav V., Thummala, Anu, Voitko, Nataliia, Bananis, Eustratios, McRoy, Lynn, Wilner, Keith, Huang, Xin, Kim, Sindy, Slamon, Dennis J., and Ettl, Johannes

Published
2020
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39. Bevacizumab biosimilar BEVZ92 versus reference bevacizumab in combination with FOLFOX or FOLFIRI as first-line treatment for metastatic colorectal cancer: a multicentre, open-label, randomised controlled trial

Author

Romera, Alvaro, Peredpaya, Sergiy, Shparyk, Yaroslav, Bondarenko, Igor, Mendonça Bariani, Giovanni, Abdalla, Kathia Cristina, Roca, Enrique, Franke, Fábio, Melo Cruz, Felipe, Ramesh, Anita, Ostwal, Vikas, Shah, Pradeep, Rahuman, Sajeed Abdul, Paravisini, Alexandra, Huerga, Camino, Del Campo García, Ana, and Millán, Susana

Published
2018
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40. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

Author

Rha, Sun Young, primary, Oh, Do-Youn, additional, Yañez, Patricio, additional, Bai, Yuxian, additional, Ryu, Min-Hee, additional, Lee, Jeeyun, additional, Rivera, Fernando, additional, Alves, Gustavo Vasconcelos, additional, Garrido, Marcelo, additional, Shiu, Kai-Keen, additional, Fernández, Manuel González, additional, Li, Jin, additional, Lowery, Maeve A, additional, Çil, Timuçin, additional, Cruz, Felipe Melo, additional, Qin, Shukui, additional, Luo, Suxia, additional, Pan, Hongming, additional, Wainberg, Zev A, additional, Yin, Lina, additional, Bordia, Sonal, additional, Bhagia, Pooja, additional, Wyrwicz, Lucjan S, additional, Mendez, Guillermo, additional, O'Connor, Juan Manuel, additional, Yanzi Castilla, Alvaro, additional, Cundom, Juan, additional, Kaen, Diego, additional, Wong, Rachel, additional, Ng, Weng, additional, Aghmesheh, Morteza, additional, Peressoni, Mauricio, additional, Andrade, Carlos, additional, Franke, Fabio, additional, Alves, Gustavo, additional, Cruz, Felipe Jose, additional, Vianna, Karina, additional, Monteiro, Maria Marcela, additional, Raphael, Michael, additional, Berry, Scott, additional, Jang, Raymond, additional, Tan, Ann, additional, Asselah, Jamil, additional, Yanez Weber, Patricio, additional, Mahave, Mauricio, additional, Sanchez, Cesar, additional, Salman, Pamela, additional, Zhang, Xiaochun, additional, Liu, Tianshu, additional, Lin, Xiaoyan, additional, Yang, Jianwei, additional, Li, Wei, additional, Ying, Jieer, additional, Chen, Xi, additional, Zeng, Shan, additional, Qu, Yanli, additional, Yang, Lin, additional, Zhao, Lin, additional, Chen, Ping, additional, Li, Enxiao, additional, Ye, Feng, additional, Lu, Jianwei, additional, Liang, Xinjun, additional, Zhao, Qun, additional, Yin, Xianli, additional, Li, Junhe, additional, Ling, Yang, additional, Lv, Guoqing, additional, Li, Shouguo, additional, Guerrero, Alvaro, additional, Rubiano, Juan, additional, Gonzalez Fernandez, Manuel, additional, Manneh Kopp, Ray, additional, Guzman Ramirez, Adrian, additional, Corrales, Luis, additional, Gonzalez Herrera, Ileana, additional, Melichar, Bohuslav, additional, Buchler, Tomas, additional, Svoboda, Tomas, additional, Obermannova, Radka, additional, Vrana, David, additional, Cvek, Jakub, additional, Pfeiffer, Per, additional, Baeksgaard, Lene, additional, Yilmaz, Mette, additional, Boige, Valerie, additional, Lopez-Trabada, Daniel, additional, Borg, Christophe, additional, Pannier, Diane, additional, Hiret, Sandrine, additional, Di Fiore, Frederic, additional, Metges, Jean-Philippe, additional, Arnold, Dirk, additional, Martens, Uwe, additional, Lordick, Florian, additional, Stein, Alexander, additional, Castro, Hugo, additional, Lopez, Karla, additional, Ramirez, Julio, additional, Aguilar, Mynor, additional, Chivalan, Marco, additional, Chan, Wendy, additional, Cheng, Ashley, additional, Yeo, Winnie, additional, Arkosy, Peter, additional, Csoszi, Tibor, additional, Hitre, Erika, additional, Horvath, Zsolt, additional, Lowery, Maeve, additional, McDermott, Ray, additional, Morris, Patrick, additional, Hubert, Ayala, additional, Brenner, Baruch, additional, Ben-Aharon, Irit, additional, Shacham-Shmueli, Einat, additional, Man, Sofia, additional, Pelles Avraham, Sharon, additional, Brenner, Ronen, additional, Mishaeli, Moshe, additional, Di Bartolomeo, Maria, additional, Fazio, Nicola, additional, Lonardi, Sara, additional, Garufi, Carlo, additional, Satoh, Taroh, additional, Hara, Hiroki, additional, Iwagami, Shiro, additional, Yasui, Hisateru, additional, Tsuda, Masahiro, additional, Shimoyama, Tatsu, additional, Shoji, Hirokazu, additional, Sugimoto, Naotoshi, additional, Shibata, Nobuhiro, additional, Yamaguchi, Kensei, additional, Amagai, Kenji, additional, Choda, Yasuhiro, additional, Esaki, Taito, additional, Yabusaki, Hiroshi, additional, Oshima, Takashi, additional, Tsuji, Akihito, additional, Kawakami, Hisato, additional, Kawazoe, Akihito, additional, Ishido, Kenji, additional, Kadowaki, Shigenori, additional, Martinez Rodriguez, Jorge, additional, Herrera Martinez, Marytere, additional, Huitzil Melendez, Fidel, additional, Ramirez Godinez, Francisco, additional, Balancan, Paola, additional, Damianovich, Dragan, additional, Castro Oliden, Victor, additional, Grados, Julio, additional, Torres, Cesar, additional, Wyrwicz, Lucjan, additional, Wysocki, Piotr, additional, Hajac, Lukasz, additional, Zolnierek, Jakub, additional, Karaszewska, Boguslawa, additional, Rha, Sun Young, additional, Orlova, Rashida, additional, Tjulandin, Sergey, additional, Fadeeva, Natalia, additional, Makarycheva, Yulia, additional, Nosov, Dmitry, additional, Smagina, Maria, additional, Chan, Sze, additional, Jacobs, Conrad, additional, Kraus, Peter, additional, Landers, Gregory, additional, Robertson, Barbara, additional, Ruff, Paul, additional, Schoeman, Elizabeth, additional, Maurel, Jean-Marc, additional, Diez Garcia, Marc, additional, Jimenez Fonseca, Paula, additional, Gallego Plazas, Javier, additional, Rivera Herrero, Fernando, additional, Miranda Poma, Jesus, additional, Layos Romero, Laura, additional, Fritsch, Ralph, additional, Bastian, Sara, additional, Winterhalder, Ralph, additional, Dosso, Sara De, additional, Kossler, Thibaud, additional, Yeh, Kun-Huei, additional, Yen, Chia-Jui, additional, Chen, Yen-Yang, additional, Lin, Johnson, additional, Bilici, Mehmet, additional, Ozguroglu, Mustafa, additional, Cil, Timucin, additional, Oksuzoglu, Berna, additional, Harputluoglu, Hakan, additional, Karaoglu, Aziz, additional, Hacibekiroglu, Ilhan, additional, Erdogan, Bulent, additional, Yalcin, Suayib, additional, Adamchuk, Hryhoriy, additional, Bondarenko, Igor, additional, Kolesnik, Oleksii, additional, Ostapenko, Yuriy, additional, Kryzhanivska, Anna, additional, Leshchenko, Lurii, additional, Ilin, Ievgen, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Voitko, Nataliia, additional, Roy, Rajarshi, additional, Young, Anna-Mary, additional, Medley, Louise, additional, Celano, Paul, additional, Overton, Lindsay, additional, Raj, Moses, additional, Dunne, Richard, additional, Wainberg, Zev, additional, Dayyani, Farshid, additional, Larson, Timothy, additional, and Kochenderfer, Mark, additional

Published
2023
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41. 600 Objective response impact on patient reported outcomes (PROs) in patients with aNSCLC with PD-L1 ≥50% receiving cemiplimab versus chemotherapy: EMPOWER-Lung 1

Author

Kilickap, Saadettin, primary, Sezer, Ahmet, additional, Gümüş, Mahmut, additional, Bondarenko, Igor, additional, Özgüroğlu, Mustafa, additional, Gogishvili, Miranda, additional, He, Xuanyao, additional, Gullo, Giuseppe, additional, Rietschel, Petra, additional, and Quek, Ruben GW, additional

Published
2023
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42. 595 Biomarker results from the 1st line non-small cell lung cancer cohort of TACTI-002: pharmacodynamic effects of combining eftilagimod alpha (soluble LAG-3) and pembrolizumab

Author

Forster, Martin, primary, Felip, Enriqueta, additional, Majem, Margarita, additional, Doger, Bernard, additional, Clay, Tim, additional, Carcereny, Enric, additional, Bondarenko, Igor, additional, Peguero, Julio, additional, Dols, Manuel Cobo, additional, Ursol, Grygorii, additional, Kalinka, Ewa, additional, Ledo, Gema Garcia, additional, Martinez, Laia Vilà, additional, Krebs, Matthew, additional, Iams, Wade T, additional, Mueller, Christian, additional, Brignone, Chrystelle, additional, and Triebel, Frederic, additional

Published
2023
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43. Durvalumab ± Tremelimumab + Platinum-Etoposide in Extensive-Stage Small Cell Lung Cancer (CASPIAN): Outcomes by PD-L1 Expression and Tissue Tumor Mutational Burden

Author

Paz-Ares, Luis, primary, Garassino, Marina Chiara, additional, Chen, Yuanbin, additional, Reinmuth, Niels, additional, Hotta, Katsuyuki, additional, Poltoratskiy, Artem, additional, Trukhin, Dmytro, additional, Hochmair, Maximilian J., additional, Özgüroğlu, Mustafa, additional, Ji, Jun Ho, additional, Statsenko, Galina, additional, Conev, Nikolay, additional, Bondarenko, Igor, additional, Havel, Libor, additional, Losonczy, György, additional, Xie, Mingchao, additional, Lai, Zhongwu, additional, Godin-Heymann, Nadia, additional, Mann, Helen, additional, Jiang, Haiyi, additional, Shrestha, Yashaswi, additional, and Goldman, Jonathan W., additional

Published
2023
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45. Randomized Phase III Placebo-Controlled Trial of Letrozole Plus Oral Temsirolimus As First-Line Endocrine Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Author

Wolff, Antonio C, Lazar, Ann A, Bondarenko, Igor, Garin, August M, Brincat, Stephen, Chow, Louis, Sun, Yan, Neskovic-Konstantinovic, Zora, Guimaraes, Rodrigo C, Fumoleau, Pierre, Chan, Arlene, Hachemi, Soulef, Strahs, Andrew, Cincotta, Maria, Berkenblit, Anna, Krygowski, Mizue, Kang, Lih Lisa, Moore, Laurence, and Hayes, Daniel F

Subjects
Breast Cancer, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Aging, Estrogen, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Disease-Free Survival, Double-Blind Method, Female, Humans, Letrozole, Middle Aged, Neoplasm Metastasis, Nitriles, Placebos, Postmenopause, Sirolimus, Treatment Outcome, Triazoles, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeRecent data showed improvement in progression-free survival (PFS) when adding everolimus to exemestane in patients with advanced breast cancer experiencing recurrence/progression after nonsteroidal aromatase inhibitor (AI) therapy. Here, we report clinical outcomes of combining the mammalian target of rapamycin (mTOR) inhibitor temsirolimus with letrozole in AI-naive patients.Patients and methodsThis phase III randomized placebo-controlled study tested efficacy/safety of first-line oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) versus letrozole/placebo in 1,112 patients with AI-naive, hormone receptor-positive advanced disease. An independent data monitoring committee recommended study termination for futility at the second preplanned interim analysis (382 PFS events).ResultsPatients were balanced (median age, 63 years; 10% stage III, 40% had received adjuvant endocrine therapy). Those on letrozole/temsirolimus experienced more grade 3 to 4 events (37% v 24%). There was no overall improvement in primary end point PFS (median, 9 months; hazard ratio [HR], 0.90; 95% CI, 0.76 to 1.07; P = .25) nor in the 40% patient subset with prior adjuvant endocrine therapy. An exploratory analysis showed improved PFS favoring letrozole/temsirolimus in patients ≤ age 65 years (9.0 v 5.6 months; HR, 0.75; 95% CI, 0.60 to 0.93; P = .009), which was separately examined by an exploratory analysis of 5-month PFS using subpopulation treatment effect pattern plot methodology (P = .003).ConclusionAdding temsirolimus to letrozole did not improve PFS as first-line therapy in patients with AI-naive advanced breast cancer. Exploratory analyses of benefit in younger postmenopausal patients require external confirmation.

Published
2013

47. PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

Author

Pegram, Mark D., Bondarenko, Igor, Zorzetto, Marina Moreira Costa, Hingmire, Sachin, Iwase, Hirotaka, Krivorotko, Petr V., Lee, Keun Seok, Li, Rubi K., Pikiel, Joanna, Aggarwal, Rajesh, Ewesuedo, Reginald, Freyman, Amy, Li, Ray, Vana, Alicia, Yin, Donghua, Zacharchuk, Charles, and Tan-Chiu, Elizabeth

Published
2019
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48. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Author

Wong, Suet-Lai Shirley, Tan, Thean Hsiang, Hovey, Elizabeth Jane, Clay, Timothy Dudley, Ng, Siobhan Su Wan, Rutten, Annemie, Machiels, Jean-Pascal, Dumez, Herlinde, Cheng, Susanna Yee-Shan, Chi, Kim Nguyen, Ferrario, Cristiano, Sengeloev, Lisa, Jensen, Niels Viggo, Thibault, Constance, Laguerre, Brigitte, Laestadius, Fredrik, Joly, Florence, Flechon, Aude, Culine, Stéphane, Becht, Catherine, Niegisch, Günter, Stöckle, Michael, Grimm, Marc-Oliver, Gakis, Georgios, Schultze-Seemann, Wolfgang, Kalofonos, Haralambos, Mavroudis, Dimitrios, Papandreou, Christos, Karavasilis, Vasilis, Bamias, Aristotelis, Révész, Janos, Geczi, Lajos, Rosenbaum, Eli, Leibowitz-Amit, Raya, Kejzman, Daniel, Peer, Avivit, Sarid, David, Scagliotti, Giorgio Vittorio, Sternberg, Cora N, Tortora, Giampaolo, Bracarda, Sergio, Necchi, Andrea, Massari, Francesco, Osawa, Takahiro, Miyajima, Naoto, Shinohara, Nobuo, Fukuta, Fumimasa, Ohyama, Chikara, Obara, Wataru, Yamashita, Shinichi, Tomita, Yoshihiko, Kawai, Koji, Fukasawa, Satoshi, Matsubara, Nobuaki, Oyama, Masafumi, Yonese, Junji, Nagata, Masayoshi, Uemura, Motohide, Nishimura, Kazuo, Kawakita, Mutsushi, Tsunemori, Hiroyuki, Hashine, Katsuyoshi, Inokuchi, Junichi, Yokomizo, Akira, Nagamori, Satoshi, Lee, Jae-Lyun, Lee, Hyo Jin, Park, Se Hoon, Rha, Sun Young, Kim, Yu Jung, Lee, Yun-Gyoo, Cortés, Leticia Vazquez, Flores, Claudia Lorena Urzua, Blaisse, Reinoud J B, van der Heijden, Michiel S, de Wit, Ronald, Erdkamp, Fransiscus L G, Aarts, Maureen J B, Wojcik-Tomaszewska, Joanna, Tomczak, Piotr, Sikora-Kupis, Bozena, Schenker, Michael, Herzal, Alina Amalia, Udrea, Anghel Adrian, Karlov, Petr, Safina, Sufia Z, Alekseev, Boris, Semenov, Andrey, Fomkin, Roman, Pulido, Enrique Grande, Del Muro, F Xavier García, Mignorance, Juan Ignacio Delgado, Gauna, Daniel Castellano, Rodríguez-Vida, Alejo, Su, Yu-Li, Ou, Yen-Chuan, Lin, Chien-Liang, Su, Wen-Pin, Lin, Chia-Chi, Yeh, Su-Peng, Çiçin, Irfan, Harputluoglu, Hakan, Erman, Mustafa, Coskun, Hasan Senol, Urun, Yuksel, Golovko, Yurii, Bondarenko, Igor, Sinielnikov, Ivan, Powles, Thomas, Crabb, Simon, Syndikus, Isabel, Huddart, Robert, Sundar, Santhanam, Chowdhury, Simon, Sarwar, Naveed, Drakaki, Alexandra, Flaig, Thomas, Pan, Chong Xian, Petrylak, Daniel, Schwarz, James, Percent, Ivor, Cultrera, Jennifer, Hainsworth, John, Herms, Benjamin, Lawler, William, Lowe, Thomas, Tagawa, Scott, Aragon-Ching, Jeanny, Vaishampayan, Ulka, Petrylak, Daniel P, Chi, Kim N, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Yu, Evan Y, Géczi, Lajos, Hegemann, Miriam, Percent, Ivor J, Tucci, Marcello, Safina, Sufia, del Muro, Xavier Garcia, Rodriguez-Vida, Alejo, Cicin, Irfan, Widau, Ryan C, Liepa, Astra M, Walgren, Richard A, Hamid, Oday, Zimmermann, Annamaria H, and Bell-McGuinn, Katherine M

Published
2017
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49. A randomised, open-label, phase 2 study of the IDO1 inhibitor epacadostat (INCB024360) versus tamoxifen as therapy for biochemically recurrent (CA-125 relapse)–only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer

Author

Kristeleit, Rebecca, Davidenko, Irina, Shirinkin, Vadim, El-Khouly, Fatima, Bondarenko, Igor, Goodheart, Michael J., Gorbunova, Vera, Penning, Carol A., Shi, Jack G., Liu, Xiangdong, Newton, Robert C., Zhao, Yufan, Maleski, Janet, Leopold, Lance, and Schilder, Russell J.

Published
2017
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50. Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): A double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation

Author

Miles, David, Cameron, David, Bondarenko, Igor, Manzyuk, Lyudmila, Alcedo, Juan Carlos, Lopez, Roberto Ivan, Im, Seock-Ah, Canon, Jean-Luc, Shparyk, Yaroslav, Yardley, Denise A., Masuda, Norikazu, Ro, Jungsil, Denduluri, Neelima, Hubeaux, Stanislas, Quah, Cheng, Bais, Carlos, and O'Shaughnessy, Joyce

Published
2017
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