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3. Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial

Author

Cho, Byoung Chul, Kim, Dong-Wan, Spira, Alexander I, Gomez, Jorge E, Haura, Eric B, Kim, Sang-We, Sanborn, Rachel E, Cho, Eun Kyung, Lee, Ki Hyeong, Minchom, Anna, Lee, Jong-Seok, Han, Ji-Youn, Nagasaka, Misako, Sabari, Joshua K, Ou, Sai-Hong Ignatius, Lorenzini, Patricia, Bauml, Joshua M, Curtin, Joshua C, Roshak, Amy, Gao, Grace, Xie, John, Thayu, Meena, Knoblauch, Roland E, and Park, Keunchil

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Clinical Trials and Supportive Activities, Lung, Lung Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Prospective Studies, Protein Kinase Inhibitors, Mutation, Aniline Compounds, ErbB Receptors, Medical and Health Sciences, Immunology, Biomedical and clinical sciences, Health sciences
Abstract

Patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) often develop resistance to current standard third-generation EGFR tyrosine kinase inhibitors (TKIs); no targeted treatments are approved in the osimertinib-relapsed setting. In this open-label, dose-escalation and dose-expansion phase 1 trial, the potential for improved anti-tumor activity by combining amivantamab, an EGFR-MET bispecific antibody, with lazertinib, a third-generation EGFR TKI, was evaluated in patients with EGFR-mutant NSCLC whose disease progressed on third-generation TKI monotherapy but were chemotherapy naive (CHRYSALIS cohort E). In the dose-escalation phase, the recommended phase 2 combination dose was established; in the dose-expansion phase, the primary endpoints were safety and overall response rate, and key secondary endpoints included progression-free survival and overall survival. The safety profile of amivantamab and lazertinib was generally consistent with previous experience of each agent alone, with 4% experiencing grade ≥3 events; no new safety signals were identified. In an exploratory cohort of 45 patients who were enrolled without biomarker selection, the primary endpoint of investigator-assessed overall response rate was 36% (95% confidence interval, 22-51). The median duration of response was 9.6 months, and the median progression-free survival was 4.9 months. Next-generation sequencing and immunohistochemistry analyses identified high EGFR and/or MET expression as potential predictive biomarkers of response, which will need to be validated with prospective assessment. ClinicalTrials.gov identifier: NCT02609776 .

Published
2023

4. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells

Author

Guan, Xiangnan, Hu, Ruozhen, Choi, Yoonha, Srivats, Shyam, Nabet, Barzin Y., Silva, John, McGinnis, Lisa, Hendricks, Robert, Nutsch, Katherine, Banta, Karl L., Duong, Ellen, Dunkle, Alexis, Chang, Patrick S., Han, Chia-Jung, Mittman, Stephanie, Molden, Nandini, Daggumati, Pallavi, Connolly, Wendy, Johnson, Melissa, Abreu, Delvys Rodriguez, Cho, Byoung Chul, Italiano, Antoine, Gil-Bazo, Ignacio, Felip, Enriqueta, Mellman, Ira, Mariathasan, Sanjeev, Shames, David S., Meng, Raymond, Chiang, Eugene Y., Johnston, Robert J., and Patil, Namrata S.

Published
2024
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7. Amivantamab Plus Lazertinib in Patients With EGFR-Mutant NSCLC After Progression on Osimertinib and Platinum-Based Chemotherapy: Results From CHRYSALIS-2 Cohort A

Author

Besse, Benjamin, Goto, Koichi, Wang, Yongsheng, Lee, Se-Hoon, Marmarelis, Melina E., Ohe, Yuichiro, Bernabe Caro, Reyes, Kim, Dong-Wan, Lee, Jong-Seok, Cousin, Sophie, Ichihara, Eiki, Li, Yongsheng, Paz-Ares, Luis, Ono, Akira, Sanborn, Rachel E., Watanabe, Naohiro, de Miguel, Maria Jose, Helissey, Carole, Shu, Catherine A., Spira, Alexander I., Tomasini, Pascale, Yang, James Chih-Hsin, Zhang, Yiping, Felip, Enriqueta, Griesinger, Frank, Waqar, Saiama N., Calles, Antonio, Neal, Joel W., Baik, Christina S., Jänne, Pasi A., Shreeve, S. Martin, Curtin, Joshua C., Patel, Bharvin, Gormley, Michael, Lyu, Xuesong, Chen, Jun, Chu, Pei-Ling, Mahoney, Janine, Trani, Leonardo, Bauml, Joshua M., Thayu, Meena, Knoblauch, Roland E., and Cho, Byoung Chul

Published
2025
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8. FURVENT: Phase 3 trial of firmonertinib vs chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertion mutations (FURMO-004)

Author

Spira, Alexander, Cho, Byoung Chul, Felip, Enriqueta, Garon, Edward B., Goto, Koichi, Johnson, Melissa, Leighl, Natasha, Passaro, Antonio, Planchard, David, Popat, Sanjay, Yang, James Chih-Hsin, Lu, Xiaoqian, Jiang, Yong, Huang, Jack, Lam, Morgan, Kowanetz, Marcin, Wang, Shirley, Le, John, Hsu, Jerry Y., and Zhou, Cai-Cun

Published
2025
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9. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes From the Phase 3 POSEIDON Trial

Author

Peters, Solange, Cho, Byoung Chul, Luft, Alexander V., Alatorre-Alexander, Jorge, Geater, Sarayut Lucien, Laktionov, Konstantin, Trukhin, Dmytro, Kim, Sang-We, Ursol, Grygorii M., Hussein, Maen, Lim, Farah Louise, Yang, Cheng-Ta, Araujo, Luiz Henrique, Saito, Haruhiro, Reinmuth, Niels, Lowery, Caitlin, Mann, Helen, Stewart, Ross, Jiang, Haiyi, Garon, Edward B., Mok, Tony, and Johnson, Melissa L.

Published
2025
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10. Author Correction: Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells

Author

Guan, Xiangnan, Hu, Ruozhen, Choi, Yoonha, Srivats, Shyam, Nabet, Barzin Y., Silva, John, McGinnis, Lisa, Hendricks, Robert, Nutsch, Katherine, Banta, Karl L., Duong, Ellen, Dunkle, Alexis, Chang, Patrick S., Han, Chia-Jung, Mittman, Stephanie, Molden, Nandini, Daggumati, Pallavi, Connolly, Wendy, Johnson, Melissa, Abreu, Delvys Rodriguez, Cho, Byoung Chul, Italiano, Antoine, Gil-Bazo, Ignacio, Felip, Enriqueta, Mellman, Ira, Mariathasan, Sanjeev, Shames, David S., Meng, Raymond, Chiang, Eugene Y., Johnston, Robert J., and Patil, Namrata S.

Published
2024
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11. Longitudinal Analyses of Circulating Tumor DNA for the Detection of EGFR Mutation-Positive Advanced NSCLC Progression During Treatment: Data From FLAURA and AURA3

Author

Gray, Jhanelle E., Markovets, Aleksandra, Reungwetwattana, Thanyanan, Majem, Margarita, Nogami, Naoyuki, Peled, Nir, Lee, Jong-Seok, Cho, Byoung Chul, Chewaskulyong, Busayamas, John, Tom, Han, Ji-Youn, Sebastian, Martin, Todd, Alexander, Rukazenkov, Yuri, Barrett, Carl, Chmielecki, Juliann, Lee, Siow Ming, Ramalingam, Suresh S., and Hartmaier, Ryan

Published
2024
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12. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With NTRK Fusion-Positive Solid TumorsEntrectinib in NTRK+ Solid Tumors: Updated Efficacy/Safety

Author

Demetri, George D, De Braud, Filippo, Drilon, Alexander, Siena, Salvatore, Patel, Manish R, Cho, Byoung Chul, Liu, Stephen V, Ahn, Myung-Ju, Chiu, Chao-Hua, Lin, Jessica J, Goto, Koichi, Lee, Jeeyun, Bazhenova, Lyudmila, John, Thomas, Fakih, Marwan, Chawla, Sant P, Dziadziuszko, Rafal, Seto, Takashi, Heinzmann, Sebastian, Pitcher, Bethany, Chen, David, Wilson, Timothy R, and Rolfo, Christian

Subjects
Cancer, Clinical Trials and Supportive Activities, Brain Disorders, Neurosciences, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Benzamides, Carcinoma, Non-Small-Cell Lung, Child, Humans, Indazoles, Lung Neoplasms, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeEntrectinib potently inhibits tropomyosin receptor kinases (TRKAs)/B/C and ROS1, and previously induced deep [objective response rate (ORR) 57.4%] and durable [median duration of response (DoR) 10.4 months] responses in adults with NTRK fusion-positive solid tumors from three phase I/II trials. This article expands prior reports with additional patients and longer follow-up.Patients and methodsPatients with locally advanced/metastatic NTRK fusion-positive solid tumors and ≥12 months' follow-up were included. Primary endpoints were ORR and DoR by blinded independent central review (BICR); secondary endpoints included progression-free survival (PFS), intracranial efficacy, and safety. The safety-evaluable populations included all patients who had received ≥1 entrectinib dose.ResultsAt clinical cut-off (August 31, 2020), the efficacy-evaluable population comprised 121 adults with 14 tumor types and ≥30 histologies. Median follow-up was 25.8 months; 61.2% of patients had a complete (n = 19) or partial response (n = 55). Median DoR was 20.0 months [95% confidence interval (CI), 13.0-38.2]; median PFS was 13.8 months (95% CI, 10.1-19.9). In 11 patients with BICR-assessed measurable central nervous system (CNS) disease, intracranial ORR was 63.6% (95% CI, 30.8-89.1) and median intracranial DoR was 22.1 (95% CI, 7.4-not estimable) months. The safety profile of entrectinib in adults and pediatric patients was aligned with previous reports. Most treatment-related adverse events (TRAEs) were grade 1/2 and manageable/reversible with dose modifications. TRAE-related discontinuations occurred in 8.3% of patients.ConclusionsWith additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses and can address the unmet need of a CNS-active treatment in patients with NTRK fusion-positive solid tumors.

Published
2022

13. Publisher Correction: Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells

Author

Guan, Xiangnan, Hu, Ruozhen, Choi, Yoonha, Srivats, Shyam, Nabet, Barzin Y., Silva, John, McGinnis, Lisa, Hendricks, Robert, Nutsch, Katherine, Banta, Karl L., Duong, Ellen, Dunkle, Alexis, Chang, Patrick S., Han, Chia-Jung, Mittman, Stephanie, Molden, Nandini, Daggumati, Pallavi, Connolly, Wendy, Johnson, Melissa, Abreu, Delvys Rodriguez, Cho, Byoung Chul, Italiano, Antoine, Gil-Bazo, Ignacio, Felip, Enriqueta, Mellman, Ira, Mariathasan, Sanjeev, Shames, David S., Meng, Raymond, Chiang, Eugene Y., Johnston, Robert J., and Patil, Namrata S.

Published
2024
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15. Pembrolizumab plus concurrent chemoradiotherapy versus placebo plus concurrent chemoradiotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (KEYNOTE-412): a randomised, double-blind, phase 3 trial

Author

Rischin, Danny, Hughes, Brett GM, Gao, Bo, McGrath, Margaret, Greil, Richard, Thurnher, Dietmar, Fuereder, Thorsten, Burian, Martin, Rottey, Sylvie, Machiels, Jean-Pascal, Clement, Paul M, Henry, Stéphanie, Deheneffe, Stéphanie, Vasconcelos Alves, Gustavo, Lima, Iane Pinto Figueiredo, Mourão Dias, Josiane, De Marchi, Pedro Rafael Martins, Mak, Milena Perez, Pereira de Santana Gomes, Andrea Juliana, Oliveira de Castro Junior, Dalvaro, Motta, Tatiane Cardoso, Agostinho Padoan, Monica Luciana, Victorina, Ana Paula, de Azevedo, Sergio Jobim, Siu, Lillian L, Brule, Stephanie, Hilton, John, Wang, Chang Shu, Bouganim, Nathaniel, Webster, Marc, Walker, John, Chua, Neil, Zambrano, Angela Regina, Quiroga Echeverri, Alicia, Niño Gomez, Oscar Mauricio, Ortiz, Carlos Alberto, Rojas, Luis, Cardona Zorilla, Andrés, Urrego Meléndez, Olga Marcela, Holečková, Petra Beran, Melichar, Bohuslav, Cvek, Jakub, Prausová, Jana, Vošmik, Milan, Delord, Jean-Pierre, Zasadny, Xavier, Geoffrois, Lionnel, Tao, Yungan, Pointreau, Yoann, Fietkau, Rainer, Haderlein, Marlen, Mueller, Andreas H, Schroeder, Ursula, Wollenberg, Barbara, Laban, Simon, Ivanyi, Philipp, Gruenwald, Viktor, Schafhausen, Philippe, Gutfeld, Orit, Gluck, Iris, Popovtzer, Aron, Meirovitz, Amichay, Billan, Salem, Brenner, Baruch, Limon, Dror, Licitra, Lisa, Perri, Francesco, Caponigro, Francesco, Violati, Martina, Ferrari, Daris, Nole, Franco, Bertolini, Federica, Livi, Lorenzo, Ghi, Maria Grazia, Imarisio, Ilaria, Tahara, Makoto, Homma, Akihiro, Ueda, Tsutomu, Asada, Yukinori, Yamazaki, Tomoko, Matsumoto, Koji, Fujii, Takashi, Ikeda, Sadakatsu, Takahashi, Shunji, Kinoshita, Takashi, Sasaki, Keita, Tsuji, Akihito, Ahn, Myung-Ju, Cho, Byoung Chul, Lee, Keun-Wook, Lee, Ki Hyeong, Choi, Moon Ki, Yun, Hwan Jung, Hendriks, Mathijs P, Oosting, Sjoukje F, Buter, Jan, Van Meerten, Esther, Graham, Jonathan, Kawecki, Andrzej, Debicka, Izabella, Maciejczyk, Adam, Pysz, Maciej, Filarska, Dorota, Hetnał, Marcin, Koralewski, Piotr, Wygoda, Andrzej, Składowski, Krzysztof, Talerczyk, Małgorzata, Berrocal Jaime, Alfonso, Pérez Segura, Pedro, Braña García, Irene, Basté Rotllan, Neus, Mesía Nin, Ricard, Taberna Sanz, Miren, Iglesias Docampo, Lara, Soria Rivas, Ainara, Rueda Domínguez, Antonio, Trigo Pérez, José Manuel, Hong, Ruey-Long, Li, Shau-Hsuan, Wang, Hung-Ming, Yen, Chia-Jui, Yang, Muh-Hwa, Chang, Yi-Fang, Liu, Yi-Chun, Lin, Jin-Ching, Ekenel, Meltem, Harputluoğlu, Hakan, Aksoy, Sercan, Özyilkan, Özgür, Bılıcı, Ahmet, Şendur, Mehmet Alı Nahıt, Arslan, Cagatay, Harrington, Kevin, Ramkumar, Shanmugasundaram, Gujral, Dorothy, Stewart, Simon, Powell, Melanie, Sibtain, Amen, Roques, Tom, Yip, Kent, Mirza, Arafat, Sivaramalingam, Muthiah, Belman, Neil D, Agarwala, Sanjiv, Anderson, Ian, Patel, Arpan, Maggiore, Ronald, Baumgart, Megan, Burtness, Barbara, Fidler, Mary Jo, Kaur, Varinder, Gaughan, Elizabeth, Worden, Francis, Rodriguez, Cristina P, Sukari, Ammar, Wong, Deborah, Yom, Sue, Walsh, William V, Fiorillo, Joseph A, Yorio, Jeffrey T, Obara, Grzegorz S, Alves, Gustavo, Hughes, Brett G M, Mesía, Ricard, Taberna, Miren, Waldron, John N, Simon, Christian, Grégoire, Vincent, Harrington, Kevin J, Swaby, Ramona F, Zhang, Yayan, Gumuscu, Burak, and Bidadi, Behzad

Published
2024
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20. A brief report on stable disease among amivantamab-treated patients with post-platinum epidermal growth factor receptor exon 20 insertion–mutated non-small cell lung cancer: A response-based analysis from the CHRYSALIS study

Author

Girard, Nicolas, Park, Keunchil, Lee, Se-Hoon, Viteri, Santiago, Schioppa, Claudio A., Diels, Joris, Oguz, Mustafa, Rodrigues, Bernardo H., Rahhali, Nora, Sermon, Jan, Ghilotti, Francesca, Li, Tracy, Thayu, Meena, Knoblauch, Roland E., Mahadevia, Parthiv, and Cho, Byoung Chul

Published
2024
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22. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non–Small Cell Lung Cancers on the LIBRETTO-001 TrialIntracranial Efficacy of Selpercatinib in RET Fusion+ NSCLC

Author

Subbiah, Vivek, Gainor, Justin F, Oxnard, Geoffrey R, Tan, Daniel SW, Owen, Dwight H, Cho, Byoung Chul, Loong, Herbert H, McCoach, Caroline E, Weiss, Jared, Kim, Yu Jung, Bazhenova, Lyudmila, Park, Keunchil, Daga, Haruko, Besse, Benjamin, Gautschi, Oliver, Rolfo, Christian, Zhu, Edward Y, Kherani, Jennifer F, Huang, Xin, Kang, Suhyun, and Drilon, Alexander

Subjects
Lung Cancer, Brain Disorders, Cancer, Clinical Trials and Supportive Activities, Lung, Clinical Research, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Proto-Oncogene Proteins c-ret, Pyrazoles, Pyridines, Treatment Outcome, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeWe report the intracranial efficacy of selpercatinib, a highly potent and selective RET inhibitor, approved in the United States for RET fusion-positive non-small cell lung cancers (NSCLC).Patients and methodsIn the global phase 1/2 LIBRETTO-001 trial (NCT03157128) in advanced RET-altered solid tumors, selpercatinib was dosed orally (160 mg twice every day) in 28-day cycles. Patients with baseline intracranial metastases had MRI/CT scans every 8 weeks for 1 year (12 weeks thereafter). In this pre-planned analysis of patients with RET fusion-positive NSCLC with baseline intracranial metastases, the primary endpoint was independently assessed intracranial objective response rate (ORR) per RECIST 1.1. Secondary endpoints included intracranial disease control rate, intracranial duration of response, and intracranial progression-free survival (PFS) independently reviewed.ResultsEighty patients with NSCLC had brain metastases at baseline. Patients were heavily pretreated (median = 2 systemic therapies, range = 0-10); 56% of patients received ≥1 course of intracranial radiation (14% whole brain radiotherapy, 45% stereotactic radiosurgery). Among 22 patients with measurable intracranial disease at baseline, intracranial ORR was 82% [95% confidence interval (CI), 60-95], including 23% with complete responses. Among all intracranial responders (measurable and nonmeasurable, n = 38), median duration of intracranial response was not reached (95% CI, 9.3-NE) at a median duration of follow-up of 9.5 months (IQR = 5.7, 12.0). At 12 months, 55% of intracranial responses were ongoing. In all 80 patients, median intracranial PFS was 13.7 months (95% CI, 10.9-NE) at a median duration of follow-up of 11.0 months (IQR = 7.4, 16.5). No new safety signals were revealed in patients with brain metastases compared with the full NSCLC trial population.ConclusionsSelpercatinib has robust and durable intracranial efficacy in patients with RET fusion-positive NSCLC.

Published
2021

23. Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1–High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial

Author

Cho, Byoung Chul, Lee, Jong Seok, Wu, Yi-Long, Cicin, Irfan, Dols, Manuel Cobo, Ahn, Myung-Ju, Cuppens, Kristof, Veillon, Rémi, Nadal, Ernest, Dias, Josiane Mourão, Martin, Claudio, Reck, Martin, Garon, Edward B., Felip, Enriqueta, Paz-Ares, Luis, Mornex, Francoise, Vokes, Everett E., Adjei, Alex A., Robinson, Clifford, Sato, Masashi, Vugmeyster, Yulia, Machl, Andreas, Audhuy, Francois, Chaudhary, Surendra, and Barlesi, Fabrice

Published
2023
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24. 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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25. Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON)

Author

Garon, Edward B., Cho, Byoung Chul, Luft, Alexander, Alatorre-Alexander, Jorge, Geater, Sarayut Lucien, Kim, Sang-We, Ursol, Grygorii, Hussein, Maen, Lim, Farah Louise, Yang, Cheng-Ta, Araujo, Luiz Henrique, Saito, Haruhiro, Reinmuth, Niels, Medic, Nenad, Mann, Helen, Shi, Xiaojin, Peters, Solange, Mok, Tony, and Johnson, Melissa

Published
2023
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27. Lazertinib Versus Gefitinib Tyrosine Kinase Inhibitors in Treatment-Naíve Patients With EGFR-Mutated Advanced NSCLC: Analysis of the Asian Subpopulation in LASER301

Author

Reungwetwattana, Thanyanan, Cho, Byoung Chul, Lee, Ki Hyeong, Pang, Yong Kek, Fong, Chin Heng, Kang, Jin Hyoung, Lee, Yun-Gyoo, Lim, Chun Sen, Danchaivijitr, Pongwut, Lim, Yueh Ni, Lee, Youngjoo, How, Soon Hin, Geater, Sarayut, Lee, Sung Sook, Min, Young Joo, Kim, Joo-Hang, Lee, Jong-Seok, Lee, Gyeong-Won, Soo, Ross A., Lee, Sae Young, Choi, SeokYoung, and Ahn, Myung-Ju

Published
2023
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33. A Phase I/Ib Trial of the VEGFR-Sparing Multikinase RET Inhibitor RXDX-105

Author

Drilon, Alexander, Fu, Siqing, Patel, Manish R, Fakih, Marwan, Wang, Ding, Olszanski, Anthony J, Morgensztern, Daniel, Liu, Stephen V, Cho, Byoung Chul, Bazhenova, Lyudmila, Rodriguez, Cristina P, Doebele, Robert C, Wozniak, Antoinette, Reckamp, Karen L, Seery, Tara, Nikolinakos, Petros, Hu, Zheyi, Oliver, Jennifer W, Trone, Denise, McArthur, Katherine, Patel, Rupal, Multani, Pratik S, and Ahn, Myung-Ju

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Lung Cancer, Cancer, Clinical Research, Lung, Adult, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, Female, Humans, Male, Middle Aged, Neoplasms, Oncogene Proteins, Fusion, Patient Safety, Phenylurea Compounds, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-ret, Quinazolines, Tissue Distribution, Treatment Outcome, Vascular Endothelial Growth Factor Receptor-1, Biochemistry and cell biology, Oncology and carcinogenesis
Abstract

RET fusions are oncogenic drivers of various tumors, including non-small cell lung cancers (NSCLC). The safety and antitumor activity of the multikinase RET inhibitor RXDX-105 were explored in a phase I/Ib trial. A recommended phase II dose of 275 mg fed daily was identified. The most common treatment-related adverse events were fatigue (25%), diarrhea (24%), hypophosphatemia (18%), maculopapular rash (18%), and nonmaculopapular rash (17%). In the phase Ib cohort of RET inhibitor-naïve patients with RET fusion-positive NSCLCs, the objective response rate (ORR) was 19% (95% CI, 8%-38%, n = 6/31). Interestingly, the ORR varied significantly by the gene fusion partner (P < 0.001, Fisher exact test): 0% (95% CI, 0%-17%, n = 0/20) with KIF5B (the most common upstream partner for RET fusion-positive NSCLC), and 67% (95% CI, 30%-93%, n = 6/9) with non-KIF5B partners. The median duration of response in all RET fusion-positive NSCLCs was not reached (range, 5 to 18+ months). SIGNIFICANCE: Although KIF5B-RET is the most common RET fusion in NSCLCs, RET inhibition with RXDX-105 resulted in responses only in non-KIF5B-RET-containing cancers. Novel approaches to targeting KIF5B-RET-containing tumors are needed, along with a deeper understanding of the biology that underlies the differential responses observed.This article is highlighted in the In This Issue feature, p. 305.

Published
2019

36. Long-Term Efficacy and Safety of Entrectinib in ROS1 Fusion–Positive NSCLC

Author

Drilon, Alexander, Chiu, Chao-Hua, Fan, Yun, Cho, Byoung Chul, Lu, Shun, Ahn, Myung-Ju, Krebs, Matthew G., Liu, Stephen V., John, Thomas, Otterson, Gregory A., Tan, Daniel S.W., Patil, Tejas, Dziadziuszko, Rafal, Massarelli, Erminia, Seto, Takashi, Doebele, Robert C., Pitcher, Bethany, Kurtsikidze, Nino, Heinzmann, Sebastian, and Siena, Salvatore

Published
2022
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37. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study

Author

Cho, Byoung Chul, Abreu, Delvys Rodriguez, Hussein, Maen, Cobo, Manuel, Patel, Anjan J, Secen, Nevena, Lee, Ki Hyeong, Massuti, Bartomeu, Hiret, Sandrine, Yang, James Chih Hsin, Barlesi, Fabrice, Lee, Dae Ho, Ares, Luis Paz, Hsieh, Robert W, Patil, Namrata S, Twomey, Patrick, Yang, Xiaoying, Meng, Raymond, and Johnson, Melissa L

Published
2022
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38. The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group.

Author

Kim, Bum Jun, Maeng, Chi Hoon, Keam, Bhumsuk, Im, Young-Hyuck, Ro, Jungsil, Jung, Kyung Hae, Im, Seock-Ah, Kim, Tae Won, Lee, Jae Lyun, Heo, Dae Seog, Kim, Sang-We, Park, Keunchil, Ahn, Myung-Ju, Cho, Byoung Chul, Kim, Hoon-Kyo, Kang, Yoon-Koo, Cho, Jae Yong, Yun, Hwan Jung, Nam, Byung-Ho, and Zang, Dae Young

Subjects
OVERALL survival, COST analysis, PROGRESSION-free survival, SURVIVAL rate, U.S. dollar
Abstract

Purpose: The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients. Materials and Methods: We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided. Results: From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient. Conclusion: Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs. [ABSTRACT FROM AUTHOR]

Published
2025
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39. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer.

Author

Ahn, Myung-Ju, Cho, Byoung Chul, Felip, Enriqueta, Korantzis, Ippokratis, Ohashi, Kadoaki, Majem, Margarita, Juan-Vidal, Oscar, Handzhiev, Sabin, Izumi, Hiroki, Lee, Jong-Seok, Dziadziuszko, Rafal, Wolf, Jürgen, Blackhall, Fiona, Reck, Martin, Alvarez, Jean Bustamante, Hummel, Horst-Dieter, Dingemans, Anne-Marie C., Sands, Jacob, Akamatsu, Hiroaki, and Owonikoko, Taofeek K.

Abstract

What is this summary about? This is a summary of a phase 2 clinical study called DeLLphi-301. The study looked at how effective and safe a medicine called tarlatamab was in participants with small cell lung cancer (SCLC). Participants previously received at least two other treatments for their SCLC. Tarlatamab is a new medicine that locates a protein called DLL3 on the cancer, which allows T cells to attack the cancer. T cells belong to the body's natural defense system known as the immune system. The DeLLphi-301 study separated participants into two groups to receive tarlatamab 10 mg or 100 mg to determine which dose best shrank SCLC with minimal side effects. All participants received a small first dose (1 mg tarlatamab) to decrease the risk of an immune system reaction called cytokine release syndrome (CRS). Tarlatamab was given through the participant's vein once every 2 weeks. This method of administration is known as intravenous (IV) infusion. What were the results of the DeLLphi-301 study? In the group given 10 mg tarlatamab, 40% of participants responded to treatment (cancer shrank). In the group given 100 mg tarlatamab, 32% of participants responded to treatment (cancer shrank). After taking tarlatamab at either dose, 59% of participants lived for at least 6 months without their cancer growing or getting worse. The most common side effect was CRS, which occurred in 51% of participants in the group given 10 mg tarlatamab and 61% of participants in the group given 100 mg tarlatamab. Other common side effects were decreased appetite, fever, constipation, and anemia. Some participants had a type of immune reaction called immune effector cell–associated neurotoxicity syndrome (ICANS). A small number of participants (3%) stopped taking tarlatamab because of side effects related to tarlatamab. What do the results from the DeLLphi-301 study mean? The study found that tarlatamab given every 2 weeks shrank SCLC in participants with SCLC who received previous treatments. Participants given the 10 mg tarlatamab dose had fewer side effects than those given the 100 mg tarlatamab dose. Clinical Trial Registration:NCT05740566 (DeLLphi-304) (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Published
2024
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40. Sitravatinib in patients with solid tumors selected by molecular alterations: results from a Phase Ib study.

Author

Bazhenova, Lyudmila, Kim, Dong-Wan, Cho, Byoung Chul, Goel, Sanjay, Heist, Rebecca, Werner, Theresa L, Eaton, Keith D, Wang, Judy S, Pant, Shubham, Adkins, Douglas R, Blakely, Collin M, Yan, Xiaohong, Neuteboom, Saskia, Christensen, James G, Chao, Richard, and Bauer, Todd

Abstract

Aim: We report clinical activity and safety of sitravatinib in patients with advanced cancer from basket cohorts with specific molecular alterations, in a Phase Ib study. Materials & methods: Patients with advanced solid tumors harboring amplification, mutation, or rearrangement of MET, AXL, RET, NTRK, DDR2, KDR, PDGFRA, KIT or CBL received sitravatinib once daily. Primary end point was confirmed objective response rate (ORR). Results: In total, 113 patients were enrolled following a median of 3 (range 1–18) prior systemic regimens. Altered RET (n = 31), CBL (n = 31) and MET (n = 17) were most frequent cohorts. Overall, 68.9% had reduced tumor volume and most (61.5%) had a best objective response of stable disease. ORR was highest in patients with RET-rearranged non-small cell lung cancer (21.1%) but did not differ significantly from the null hypothesis (ORR ≤15%; p = 0.316). Median progression-free survival and overall survival (5.7 and 24.2 months, respectively) were also longest in the RET-rearranged non-small cell lung cancer cohort. Diarrhea (61.1%), fatigue (50.4%) and hypertension (46.9%) were the most frequent treatment-emergent adverse events. Most treatment-emergent adverse events were mild-to-moderate in severity. The study closed before the planned number of patients were enrolled in all cohorts. Conclusion: Sitravatinib had a manageable safety profile with modest signals of clinical activity in patients with molecularly selected solid tumors. Clinical trial registration: www.clinicaltrials.gov identifier is NCT02219711 Plain Language Summary We report findings from a clinical study of sitravatinib which included patients with cancer that could not be removed by surgery or had spread to other parts of the body. The tumors of these patients contained specific molecular changes in one of the following genes: MET, AXL, RET, NTRK, DDR2, KDR, PDGFRA, KIT or CBL. All patients received treatment with sitravatinib once a day. Change in tumor size over time was assessed to see how effective treatment with sitravatinib was. In total, 113 patients joined the study. Most patients had already received a median of three different types of medicines for their cancer (and up to 18 different types of anticancer medicines). Most patients had tumors that contained alterations in RET, CBL or MET genes. During the study, the percentage of patients who had a decrease in the tumor size was highest in the group with non-small cell lung cancer that contained an altered RET gene (21.1%). However, this level of response to sitravatinib was not considered high enough to be medically important. The most common side effects during the study were diarrhea (61.1%), fatigue (50.4%) and high blood pressure (46.9%). Most side effects were mild or moderate in severity. The study provided the opportunity to assess sitravatinib as a treatment for cancers with specific gene mutations that are uncommon; the study closed before the planned number of patients were enrolled. In conclusion, the side effects seen in patients who received sitravatinib were manageable. Signals of how well sitravatinib worked were modest in patients with cancer that had spread to other parts of the body and contained specific molecular changes. Article highlights Basket trials that enroll cohorts of patients with various tumor types that harbor specific molecular alterations can inform the activity of novel treatments for rare genetic drivers, helping ensure patients receive treatment that is based on the molecular signature of their disease. Sitravatinib (MGCD516) is an oral small molecule inhibitor that targets a spectrum of closely related receptor tyrosine kinases involved in cancer development, predominantly TAM family (TYRO3, AXL, MERTK) and split family (VEGFR2, MET, RET, KIT) receptors. We report clinical activity and safety with sitravatinib in patients with advanced solid tumors that harbored genetic alterations relevant to the mechanism of action of sitravatinib, who participated in the Phase Ib basket study cohorts of the first-in-human study. Overall, 113 heavily pre-treated patients were enrolled; patients with tumors containing alterations in RET (n = 31), CBL (n = 31) and MET (n = 17) were the most frequent cohorts. Overall, the clinical activity of sitravatinib was modest: while most patients (68.9%) experienced a reduction in tumor volume, the majority (61.5%) had a best objective response of stable disease. Objective response rate was highest in patients with RET-rearranged NSCLC (21.1%) but this did not differ significantly from the null hypothesis (ORR ≤15%; p = 0.316). Despite the basket-cohort approach to enrollment, fewer patients than planned were enrolled across the cohorts in the timeframe of the study; this prevented further refinement of molecular alteration subtypes for which sitravatinib may have clinical utility. Sitravatinib had a manageable safety profile: most adverse events were mild-to-moderate in severity, with diarrhea (61.1%), fatigue (50.4%) and hypertension (46.9%) being most frequently observed. [ABSTRACT FROM AUTHOR]

Published
2024
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41. A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12).

Author

Lee, Dong Ki, Park, Sook Ryun, Kim, Yeul Hong, Lee, Yun-Gyoo, Shin, Su-Jin, Ahn, Beung-Chul, Lee, Sung Sook, Lim, Sun Min, Kim, Hye Ryun, Cho, Byoung Chul, and Hong, Min Hee

Subjects
PROGRAMMED death-ligand 1, IMMUNE checkpoint inhibitors, SQUAMOUS cell carcinoma, OVERALL survival, PROGRESSION-free survival
Abstract

Spartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We conducted a single-arm, phase 2 trial to investigate the efficacy and safety of spartalizumab in patients with refractory esophageal squamous cell carcinoma (ESCC). Patients with histologically confirmed ESCC who experienced disease progression after platinum-based chemotherapy received 300 mg of intravenous spartalizumab every three weeks until disease progression or occurrence of unacceptable toxicity. The primary endpoint was centrally assessed objective response according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Adverse events were closely monitored throughout the study. From March 2020 through April 2021, 44 patients with ESCC were enrolled. Of the 44 patients, the objective response rate was 20.5% (95% confidence interval: 8.5–32.4). With a median follow-up of 10.9 months, median progression-free survival and overall survival were 3.2 months and 11.2 months, respectively. In addition, the median duration of response was 24.7 months. The most common grade 3 or 4 adverse event was grade 3 dysphagia (eight [18%] patients). Biomarker analyses explored programmed cell death ligand 1 and CD20 as potential predictive markers for PD-1 blockade. Spartalizumab showed promising activity with a manageable safety profile, indicating its potential as a new treatment option for patients with refractory ESCC. Trial registration: The trial was registered at ClinicalTrials.gov under the identifier NCT03785496. [ABSTRACT FROM AUTHOR]

Published
2024
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42. A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors

Author

Cho, Byoung Chul, Han, Ji-Youn, Kim, Sang-We, Lee, Ki Hyeong, Cho, Eun Kyung, Lee, Yun-Gyoo, Kim, Dong-Wan, Kim, Joo-Hang, Lee, Gyeong-Won, Lee, Jong-Seok, Shim, Byoung Yong, Kim, Jin-Soo, Chun, Sang Hoon, Lee, Sung Sook, Kim, Hye Ryun, Hong, Min Hee, Ahn, Jin Seok, Sun, Jong-Mu, Lee, Youngjoo, Lee, Dae Ho, Kang, Ji Ah, Lee, NaMi, Kwon, Mi-Jung, Espenschied, Carin, Yablonovitch, Arielle, and Ahn, Myung-Ju

Published
2022
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44. A randomised phase II study of osimertinib and bevacizumab versus osimertinib alone as second-line targeted treatment in advanced NSCLC with confirmed EGFR and acquired T790M mutations: the European Thoracic Oncology Platform (ETOP 10-16) BOOSTER trial

Author

Stahel, Rolf, Peters, Solange, Soo, Ross, Han, Ji-Youn, Früh, Martin, Provencio, Mariano, Coate, Linda, Dafni, Urania, Hiltbrunner, Anita, Ruepp, Barbara, Roschitzki-Voser, Heidi, Gasca-Ruchti, Adriana, Giacomelli, Nino, Kammler, Rosita, Marti, Nesa, Nobs, Lionel, Pardo-Contreras, Mariana, Pfister, Rita, Piguet, Anne-Christine, Ribeli-Hofmann, Sabrina, Martinez, Virginia Rodriguez, Roux, Susanne, Sanchez-Hohl, Magdalena, Schneider, Mirjam, Schweri, Robin, Troesch, Sandra, Zigomo, Isabel, Tsourti, Zoi, Zygoura, Panagiota, Kassapian, Marie, Vervita, Katerina, Dimopoulou, Georgia, Andriakopoulou, Charitini, Fernandez, Maria, Pereira, Eva, Simona, Carolina, Tucker, Lisa, Burnes, Jillian, Barrett, Aisling, McGrillen, Meghan, Berset, Catherine, Biaggi, Christine, Reist, Martin, Rentsch, Priska, Cuffe, Sinead, Hashemi, Sayed, Nadal, Ernest, Carcereny, Enric, de Castro, Javier, Sala, Maria Angeles, Reyes, Bernabé, Pulla, Mariano Provencio, Campelo, Rosario Garcia, Massutí, Bartomeu, Garcia, Jose, Dómine, Manuel, Majem, Margarita, Sanchez, Jose Miguel, Britschgi, Christian, Pless, Miklos, Yeo, Chong Ming, Cho, Byoung Chul, Soo, R.A., Han, J.-Y., Dafni, U., Cho, B.C., Yeo, C.M., Nadal, E., Carcereny, E., de Castro, J., Sala, M.A., Bernabé, R., Coate, L., Provencio Pulla, M., Garcia Campelo, R., Cuffe, S., Hashemi, S.M.S., Früh, M., Massuti, B., Garcia-Sanchez, J., Dómine, M., Majem, M., Sanchez-Torres, J.-M., Britschgi, C., Pless, M., Dimopoulou, G., Roschitzki-Voser, H., Ruepp, B., Rosell, R., Stahel, R.A., and Peters, S.

Published
2022
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45. ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC).

Author

Spigel, David R., primary, Cheng, Ying, additional, Cho, Byoung Chul, additional, Laktionov, Konstantin K., additional, Fang, Jian, additional, Chen, Yuanbin, additional, Zenke, Yoshitaka, additional, Lee, Ki Hyeong, additional, Wang, Qiming, additional, Navarro, Alejandro, additional, Bernabe Caro, Reyes, additional, Buchmeier, Eva Lotte, additional, Chang, John W. C., additional, Okamoto, Isamu, additional, Sezgin Goksu, Sema, additional, Badzio, Andrzej, additional, Gill, Bethany, additional, Gowda, Hema, additional, Jiang, Haiyi, additional, and Senan, Suresh, additional

Published
2024
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46. A phase 1 study of fianlimab (anti–LAG-3) in combination with cemiplimab (anti–PD-1) in patients with advanced HNSCC.

Author

Cho, Byoung Chul, primary, Hamid, Omid, additional, Zhu, Xinhua, additional, Keam, Bhumsuk, additional, Kaczmar, John M., additional, Williamson, Stephen K., additional, Birnbaum, Ariel E., additional, Dowlati, Afshin, additional, Dy, Grace K., additional, Hager, Steven Jeffrey, additional, Lynce, Filipa, additional, McDermott, Raymond S., additional, Sarker, Debashis, additional, Weise, Amy M., additional, Yap, Timothy A., additional, Yilmaz, Emrullah, additional, Fang, Fang, additional, Mani, Jayakumar, additional, Kroog, Glenn Scott, additional, and Papadopoulos, Kyriakos P., additional

Published
2024
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47. FURVENT: Phase 3 trial of furmonertinib vs chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertion mutations (FURMO-004).

Author

Spira, Alexander I., primary, Cho, Byoung Chul, additional, Felip, Enriqueta, additional, Garon, Edward B., additional, Goto, Koichi, additional, Johnson, Melissa Lynne, additional, Leighl, Natasha B., additional, Passaro, Antonio, additional, Planchard, David, additional, Popat, Sanjay, additional, Yang, James Chih-Hsin, additional, Lu, Xiaoqian, additional, Jiang, Yong, additional, Huang, Jack, additional, Lam, Morgan, additional, Kowanetz, Marcin, additional, Wang, Shirley, additional, Le, John, additional, Hsu, Jerry Y., additional, and Zhou, Caicun, additional

Published
2024
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49. Five Year Survival Update From KEYNOTE-010: Pembrolizumab Versus Docetaxel for Previously Treated, Programmed Death-Ligand 1–Positive Advanced NSCLC

Author

Herbst, Roy S., Garon, Edward B., Kim, Dong-Wan, Cho, Byoung Chul, Gervais, Radj, Perez-Gracia, Jose L., Han, Ji-Youn, Majem, Margarita, Forster, Martin D., Monnet, Isabelle, Novello, Silvia, Gubens, Matthew A., Boyer, Michael, Su, Wu-Chou, Samkari, Ayman, Jensen, Erin H., Kobie, Julie, Piperdi, Bilal, and Baas, Paul

Published
2021
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