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4. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial

Author

Fizazi, Karim, Azad, Arun A., Matsubara, Nobuaki, Carles, Joan, Fay, Andre P., De Giorgi, Ugo, Joung, Jae Young, Fong, Peter C. C., Voog, Eric, Jones, Robert J., Shore, Neal D., Dunshee, Curtis, Zschäbitz, Stefanie, Oldenburg, Jan, Ye, Dingwei, Lin, Xun, Healy, Cynthia G., Di Santo, Nicola, Laird, A. Douglas, Zohren, Fabian, and Agarwal, Neeraj

Published
2024
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5. Publisher Correction: First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial

Author

Fizazi, Karim, Azad, Arun A., Matsubara, Nobuaki, Carles, Joan, Fay, Andre P., De Giorgi, Ugo, Joung, Jae Young, Fong, Peter C. C., Voog, Eric, Jones, Robert J., Shore, Neal D., Dunshee, Curtis, Zschäbitz, Stefanie, Oldenburg, Jan, Ye, Dingwei, Lin, Xun, Healy, Cynthia G., Di Santo, Nicola, Laird, A. Douglas, Zohren, Fabian, and Agarwal, Neeraj

Published
2024
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6. Exposure‐response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy

Author

Wit, Ronald, Powles, Thomas, Castellano, Daniel, Necchi, Andrea, Lee, Jae‐Lyun, Heijden, Michiel S, Matsubara, Nobuaki, Bamias, Aristotelis, Fléchon, Aude, Sternberg, Cora N, Drakaki, Alexandra, Yu, Evan Y, Zimmermann, Annamaria H, Long, Amanda, Walgren, Richard A, Gao, Ling, Bell‐McGuinn, Katherine M, and Petrylak, Daniel P

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Humans, Platinum, Urinary Bladder Neoplasms, exposure-response, overall survival, progression-free survival, ramucirumab, urothelial carcinoma, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

AimsPatients with advanced urothelial carcinoma (UC) who progress after platinum-based chemotherapy have a poor prognosis, and there is a medical need to improve current treatment options. Ramucirumab plus docetaxel significantly improved progression-free survival but not overall survival (OS) in platinum-refractory advanced UC (RANGE trial; NCT02426125). Here, we report the exposure-response (ER) of ramucirumab plus docetaxel using data from the RANGE trial.MethodsPharmacokinetic (PK) samples were collected (cycle 1-3, 5, 9 [day 1] and 30 days from treatment discontinuation), and PK data were analysed using population PK (popPK) analysis. The minimum ramucirumab concentration after first dose administration (Cmin,1 , or trough concentration immediately prior to the second dose) was derived by popPK analysis and used as the exposure parameter for ER analysis. Cox proportional hazards regression models and matched case-control analyses were used to evaluate the relationship between Cmin,1 and OS. The Cmin,1 relationship with safety was assessed descriptively.ResultsSeveral poor prognostic factors (ECOG 1, haemoglobin concentration

Published
2022

7. Health-related Quality of Life in Patients with Previously Treated Advanced Urothelial Carcinoma from EV-301: A Phase 3 Trial of Enfortumab Vedotin Versus Chemotherapy

Author

Rosenberg, Jonathan E., Mamtani, Ronac, Sonpavde, Guru P., Loriot, Yohann, Duran, Ignacio, Lee, Jae-Lyun, Matsubara, Nobuaki, Vulsteke, Christof, Castellano, Daniel, Sridhar, Srikala S., Pappot, Helle, Gurney, Howard, Bedke, Jens, van der Heijden, Michiel S., Galli, Luca, Keam, Bhumsuk, Masumori, Naoya, Meran, Johannes, O'Donnell, Peter H., Park, Se Hoon, Grande, Enrique, Sengeløv, Lisa, Uemura, Hiroji, Skaltsa, Konstantina, Campbell, Mary, Matsangou, Maria, Wu, Chunzhang, Hepp, Zsolt, McKay, Caroline, Powles, Thomas, and Petrylak, Daniel P.

Published
2024
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9. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial

Author

van der Heijden, Michiel S, Powles, Thomas, Petrylak, Daniel, de Wit, Ronald, Necchi, Andrea, Sternberg, Cora N, Matsubara, Nobuaki, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed A, Bamias, Aristotelis, Gakis, Georgios, Lee, Jae-Lyun, Tagawa, Scott T, Vaishampayan, Ulka, Aragon-Ching, Jeanny B, Eigl, Bernie J, Hozak, Rebecca R, Rasmussen, Erik R, Xia, Meng Summer, Rhodes, Ryan, Wijayawardana, Sameera, Bell-McGuinn, Katherine M, Aggarwal, Amit, and Drakaki, Alexandra

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Genetic Testing, Cancer, Genetics, Good Health and Well Being, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Biomarkers, Biomarkers, Tumor, Carcinoma, Transitional Cell, Humans, Urinary Bladder Neoplasms
Abstract

The RANGE study (NCT02426125) evaluated ramucirumab (an anti-VEGFR2 monoclonal antibody) in patients with platinum-refractory advanced urothelial carcinoma (UC). Here, we use programmed cell death-ligand 1 (PD-L1) immunohistochemistry (IHC) and transcriptome analysis to evaluate the association of immune and angiogenesis pathways, and molecular subtypes, with overall survival (OS) in UC. Higher PD-L1 IHC and immune pathway scores, but not angiogenesis scores, are associated with greater ramucirumab OS benefit. Additionally, Basal subtypes, which have higher PD-L1 IHC and immune/angiogenesis pathway scores, show greater ramucirumab OS benefit compared to Luminal subtypes, which have relatively lower scores. Multivariable analysis suggests patients from East Asia as having lower immune/angiogenesis signature scores, which correlates with decreased ramucirumab OS benefit. Our data highlight the utility of multiple biomarkers including PD-L1, molecular subtype, and immune phenotype in identifying patients with UC who might derive the greatest benefit from treatment with ramucirumab.

Published
2022

10. Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial

Author

Matsubara, Nobuaki, de Wit, Ronald, Balar, Arjun Vasant, Siefker-Radtke, Arlene O., Zolnierek, Jakub, Csoszi, Tibor, Shin, Sang Joon, Park, Se Hoon, Atduev, Vagif, Gumus, Mahmut, Su, Yu-Li, Karaca, Saziye Burcak, Cutuli, Hernán Javier, Sendur, Mehmet A.N., Shen, Liji, O'Hara, Karen, Okpara, Chinyere E., Franco, Sonia, Moreno, Blanca Homet, Grivas, Petros, and Loriot, Yohann

Published
2024
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12. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial

Author

Agarwal, Neeraj, Azad, Arun A, Carles, Joan, Fay, Andre P, Matsubara, Nobuaki, Heinrich, Daniel, Szczylik, Cezary, De Giorgi, Ugo, Young Joung, Jae, Fong, Peter C C, Voog, Eric, Jones, Robert J, Shore, Neal D, Dunshee, Curtis, Zschäbitz, Stefanie, Oldenburg, Jan, Lin, Xun, Healy, Cynthia G, Di Santo, Nicola, Zohren, Fabian, and Fizazi, Karim

Published
2023
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13. Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE).

Author

Necchi, Andrea, Nishiyama, Hiroyuki, Matsubara, Nobuaki, Lee, Jae-Lyun, Petrylak, Daniel, de Wit, Ronald, Drakaki, Alexandra, Liepa, Astra, Mao, Huzhang, Bell-McGuinn, Katherine, and Powles, Thomas

Subjects
Antiangiogenesis, Bladder cancer, Neoplasm metastatsis, Patient-reported outcomes, Quality of life, Ramucirumab, Urinary bladder neoplasm, Urothelial carcinoma, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Double-Blind Method, Female, Humans, Male, Middle Aged, Neoplasm Staging, Quality of Life, Urologic Neoplasms, Ramucirumab
Abstract

BACKGROUND: To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC). METHODS: RANGE-a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) or placebo plus docetaxel were administered every 21 days until disease progression or unacceptable toxicity. Patients received maximum 10 cycles of docetaxel. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EuroQoL five-dimensions (EQ-5D-5L) were administered at baseline, start of each cycle, and 30-day follow-up visit. A ≥ 10-point change in QLQ-C30 scores was considered meaningful. Rates of improved/stable scores were compared between treatment arms using Fishers exact test. Time to deterioration (TtD) was estimated and compared using Kaplan-Meier estimation and log-rank test. RESULTS: Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQ-C30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit. CONCLUSIONS: Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment. CLINICAL TRAIL REGISTRATION: NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125 . Date of registration: April 24th 2015.

Published
2020

15. 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

Petrylak, Daniel, de Wit, Ronald, Chi, Kim, Drakaki, Alexandra, Sternberg, Cora, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan, van der Heijden, Michiel, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor, 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, Vaishampayan, Ulka, Aragon-Ching, Jeanny, Hamid, Oday, Liepa, Astra, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard, Zimmermann, Annamaria, Hozak, Rebecca, Bell-McGuinn, Katherine, and Powles, Thomas

Subjects
Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Metastasis, Platinum, Prognosis, Salvage Therapy, Survival Rate, Urologic Neoplasms, Ramucirumab
Abstract

BACKGROUND: Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. FINDINGS: Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. INTERPRETATION: Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. FUNDING: Eli Lilly and Company.

Published
2020

17. Discovery of a novel non-negative matrix factorization (NMF)-based homologous recombination deficiency (HRD) score and subsequent exploration in TALAPRO-2 (TP-2), a phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Author

Fizazi, Karim, primary, Roh, Whijae, additional, Azad, Arun, additional, Mu, Xinmeng Jasmine, additional, Matsubara, Nobuaki, additional, Yip, Steven, additional, Zschaebitz, Stefanie, additional, Piulats, Josep M., additional, Liu, Glenn, additional, Jones, Robert J., additional, Saul, Michelle, additional, Engelsberg, Arne, additional, Chelliserry, Jijumon, additional, Laird, Douglas, additional, and Agarwal, Neeraj, additional

Published
2024
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18. Impact of exposure on outcomes with enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer.

Author

Petrylak, Daniel P., primary, Chia, Yen Lin, additional, Yu, Evan Y., additional, Powles, Thomas, additional, Flaig, Thomas W., additional, Loriot, Yohann, additional, O'Donnell, Peter H., additional, Heath, Elisabeth I., additional, Kojima, Takahiro, additional, Park, Se Hoon, additional, Sonpavde, Guru P., additional, Picus, Joel, additional, Matsubara, Nobuaki, additional, Obara, Wataru, additional, Chudasama, Vaishali, additional, Poondru, Srinivasu, additional, Harrison, Michael, additional, Kim, Eric, additional, Brancato, Sam Joseph, additional, and Rosenberg, Jonathan E., additional

Published
2024
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19. Utility of ctDNA burden as a prognostic biomarker for efficacy in TALAPRO-2: A phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Author

Azad, Arun, primary, Fizazi, Karim, additional, Laird, Douglas, additional, Matsubara, Nobuaki, additional, De Giorgi, Ugo, additional, ButtIgliero, Consuelo, additional, Karsh, Lawrence Ivan, additional, Joung, Jae Young, additional, Yip, Steven, additional, Zschaebitz, Stefanie, additional, Albacker, Lee A., additional, Healy, Cynthia G., additional, Lin, Xun, additional, Chelliserry, Jijumon, additional, and Agarwal, Neeraj, additional

Published
2024
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20. Exploration of circulating tumor cell (CTC) conversion and CTC0 as prognostic biomarkers for efficacy in TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Author

Yip, Steven, primary, Fizazi, Karim, additional, Laird, Douglas, additional, Matsubara, Nobuaki, additional, Azad, Arun, additional, Joung, Jae Young, additional, Fong, Peter C.C., additional, Van Bruwaene, Siska, additional, Liu, Glenn, additional, Voog, Eric, additional, Szczylik, Cezary, additional, Chelliserry, Jijumon, additional, Healy, Cynthia G., additional, Lin, Xun, additional, and Agarwal, Neeraj, additional

Published
2024
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21. Supplementary Methods S1 from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer

Author

Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary

Published
2024
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22. Supplementary Table S3 from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer

Author

Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary

Published
2024
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23. Supplementary Figure S2 from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer

Author

Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary

Published
2024
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24. Data from A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer

Author

Dorff, Tanya, primary, Horvath, Lisa G., primary, Autio, Karen, primary, Bernard-Tessier, Alice, primary, Rettig, Matthew B., primary, Machiels, Jean-Pascal, primary, Bilen, Mehmet A., primary, Lolkema, Martijn P., primary, Adra, Nabil, primary, Rottey, Sylvie, primary, Greil, Richard, primary, Matsubara, Nobuaki, primary, Tan, Daniel S.W., primary, Wong, Alvin, primary, Uemura, Hiroji, primary, Lemech, Charlotte, primary, Meran, Johannes, primary, Yu, Youfei, primary, Minocha, Mukul, primary, McComb, Mason, primary, Penny, Hweixian Leong, primary, Gupta, Vinita, primary, Hu, Xuguang, primary, Jurida, Gabor, primary, Kouros-Mehr, Hosein, primary, Janát-Amsbury, Margit M., primary, Eggert, Tobias, primary, and Tran, Ben, primary

Published
2024
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25. Supplementary Tables S1-S5 from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma

Author

Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary

Published
2024
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26. Data from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma

Author

Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary

Published
2024
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27. Supplementary Legends from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma

Author

Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary

Published
2024
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28. Supplementary Figure S1 from TAS0313 plus Pembrolizumab for Post-Chemotherapy Immune Checkpoint Inhibitor—Naïve Locally Advanced or Metastatic Urothelial Carcinoma

Author

Nishiyama, Hiroyuki, primary, Yonese, Junji, primary, Kawahara, Takashi, primary, Matsumoto, Ryuji, primary, Miyake, Hideaki, primary, Matsubara, Nobuaki, primary, Uemura, Hiroji, primary, Eto, Masatoshi, primary, Azuma, Haruhito, primary, Obara, Wataru, primary, Terai, Akito, primary, Fukasawa, Satoshi, primary, and Suekane, Shigetaka, primary

Published
2024
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29. PD‐1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study

Author

Kuboki, Yasutoshi, primary, Koyama, Takafumi, additional, Matsubara, Nobuaki, additional, Naito, Yoichi, additional, Kondo, Shunsuke, additional, Harano, Kenichi, additional, Yonemori, Kan, additional, Yoh, Kiyotaka, additional, Gu, Yuan, additional, Mita, Tetsuya, additional, Chen, Xuejun, additional, Ueda, Eiji, additional, Yamamoto, Noboru, additional, Doi, Toshihiko, additional, and Shimizu, Toshio, additional

Published
2024
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30. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial

Author

Powles, Thomas, Yuen, Kobe C., Gillessen, Silke, Kadel, III, Edward E., Rathkopf, Dana, Matsubara, Nobuaki, Drake, Charles G., Fizazi, Karim, Piulats, Josep M., Wysocki, Piotr J., Buchschacher, Jr, Gary L., Alekseev, Boris, Mellado, Begoña, Karaszewska, Bogusława, Doss, Jennifer F., Rasuo, Grozdana, Datye, Asim, Mariathasan, Sanjeev, Williams, Patrick, and Sweeney, Christopher J.

Published
2022
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31. Pembrolizumab plus axitinib versus sunitinib in metastatic renal cell carcinoma: outcomes of Japanese patients enrolled in the randomized, phase III, open-label KEYNOTE-426 study

Author

Tamada, Satoshi, Kondoh, Chihiro, Matsubara, Nobuaki, Mizuno, Ryuichi, Kimura, Go, Anai, Satoshi, Tomita, Yoshihiko, Oyama, Masafumi, Masumori, Naoya, Kojima, Takahiro, Matsumoto, Hiroaki, Chen, Mei, Li, Mengran, Matsuda, Kenji, Tanaka, Yoshinobu, Rini, Brian I., and Uemura, Hirotsugu

Published
2022
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33. IMAGENE trial: multicenter, proof-of-concept, phase II study evaluating the efficacy and safety of combination therapy of niraparib with PD-1 inhibitor in solid cancer patients with homologous recombination repair genes mutation

Author

Kato, Taigo, Matsubara, Nobuaki, Shiota, Masaki, Eto, Masatoshi, Osawa, Takahiro, Abe, Takashige, Shinohara, Nobuo, Yasumizu, Yota, Tanaka, Nobuyuki, Oya, Mototsugu, Nishimoto, Koshiro, Hayashi, Takuji, Nakayama, Masashi, Kojima, Takahiro, Namikawa, Kenjiro, Fujisawa, Takao, Okano, Susumu, Hida, Eisuke, Nakamura, Yoshiaki, Bando, Hideaki, Yoshino, Takayuki, and Nonomura, Norio

Published
2022
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34. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial

Author

Thiery-Vuillemin, Antoine, de Bono, Johann, Hussain, Maha, Roubaud, Guilhem, Procopio, Giuseppe, Shore, Neal, Fizazi, Karim, dos Anjos, Gabriel, Gravis, Gwenaelle, Joung, Jae Young, Matsubara, Nobuaki, Castellano, Daniel, Degboe, Arnold, Gresty, Chris, Kang, Jinyu, Allen, Allison, Poehlein, Christian, and Saad, Fred

Published
2022
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39. Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial

Author

Mateo, Joaquin, primary, de Bono, Johann S., additional, Fizazi, Karim, additional, Saad, Fred, additional, Shore, Neal, additional, Sandhu, Shahneen, additional, Chi, Kim N., additional, Agarwal, Neeraj, additional, Olmos, David, additional, Thiery-Vuillemin, Antoine, additional, Özgüroğlu, Mustafa, additional, Mehra, Niven, additional, Matsubara, Nobuaki, additional, Young Joung, Jae, additional, Padua, Charles, additional, Korbenfeld, Ernesto, additional, Kang, Jinyu, additional, Marshall, Helen, additional, Lai, Zhongwu, additional, Barnicle, Alan, additional, Poehlein, Christian, additional, Lukashchuk, Natalia, additional, and Hussain, Maha, additional

Published
2024
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40. A phase 1 study of acapatamab, a half-life extended, PSMA-targeting bispecific T-cell engager for metastatic castration-resistant prostate cancer

Author

Dorff, Tanya, primary, Horvath, Lisa G., additional, Autio, Karen, additional, Bernard-Tessier, Alice, additional, Rettig, Matthew B., additional, Machiels, Jean-Pascal, additional, Bilen, Mehmet A., additional, Lolkema, Martijn P., additional, Adra, Nabil, additional, Rottey, Sylvie, additional, Greil, Richard, additional, Matsubara, Nobuaki, additional, Tan, Daniel S.W., additional, Wong, Alvin, additional, Uemura, Hiroji, additional, Lemech, Charlotte, additional, Meran, Johannes, additional, Yu, Youfei, additional, Minocha, Mukul, additional, McComb, Mason, additional, Penny, Hweixian Leong., additional, Gupta, Vinita, additional, Hu, Xuguang, additional, Jurida, Gabor, additional, Kouros-Mehr, Hosein, additional, Janát-Amsbury, Margit M., additional, Eggert, Tobias, additional, and Tran, Ben, additional

Published
2024
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41. Supplementary Table S1 from Xaluritamig, a STEAP1 × CD3 XmAb 2+1 Immune Therapy for Metastatic Castration-Resistant Prostate Cancer: Results from Dose Exploration in a First-in-Human Study

Author

Kelly, William K., primary, Danila, Daniel C., primary, Lin, Chia-Chi, primary, Lee, Jae-Lyun, primary, Matsubara, Nobuaki, primary, Ward, Patrick J., primary, Armstrong, Andrew J., primary, Pook, David, primary, Kim, Miso, primary, Dorff, Tanya B., primary, Fischer, Stefanie, primary, Lin, Yung-Chang, primary, Horvath, Lisa G., primary, Sumey, Christopher, primary, Yang, Zhao, primary, Jurida, Gabor, primary, Smith, Kristen M., primary, Connarn, Jamie N., primary, Penny, Hweixian L., primary, Stieglmaier, Julia, primary, and Appleman, Leonard J., primary

Published
2024
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42. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial

Author

Sweeney, Christopher, Bracarda, Sergio, Sternberg, Cora N, Chi, Kim N, Olmos, David, Sandhu, Shahneen, Massard, Christophe, Matsubara, Nobuaki, Alekseev, Boris, Parnis, Francis, Atduev, Vagif, Buchschacher, Gary L, Jr, Gafanov, Rustem, Corrales, Luis, Borre, Michael, Stroyakovskiy, Daniil, Alves, Gustavo Vasconcelos, Bournakis, Evangelos, Puente, Javier, Harle-Yge, Marie-Laurence, Gallo, Jorge, Chen, Geng, Hanover, Justin, Wongchenko, Matthew J, Garcia, Josep, and de Bono, Johann S

Published
2021
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43. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Cascallar, Diana Vera, Varela, Mirta, Lazzaro, Mauricio Fernandez, Kaen, Diego Lucas, Gatica, Gabriela, Flores, David Hugo, Falco, Agustin, Molina, Matias, Van Aelst, Filip, Vulsteke, Christof, Sautois, Brieuc, Machiels, Jean-Pascal, Schallier, Denis, Brust, Leandro, Rapatoni, Liane, Azevedo, Sergio J, Marinho, Gisele, Soares, Joao Paulo Holanda, Dzik, Carlos, Almeida Silva, Jamile, Fay, Andre Poisl, Gingerich, Joel, Fradet, Yves, Ferrario, Cristiano, Potvin, Kylea, Vanhuyse, Marie, Abdelsalam, Mahmoud, Cheng, Susanna, Caglevic, Christian, Reyes, Felipe, Leal, Jose Luis, Francisco, Francisco, Ibanez, Carolina, Joly, Florence, Laguerre, Brigitte, Ladoire, Sylvain, Flechon, Aude, Topart, Delphine, Huillard, Olivier, Oudard, Stéphane, Gross-Goupil, Marine, Culine, Stephane, Loriot, Yohann, Gravis, Gwenaelle, Reichardt, Peter, Retz, Margitta, Herden, Jan, Pfister, David, Ohlman, Carsten, Stoeckle, Michael, Wirth, Manfred, Lorch, Anja, Niegisch, Guenter, Goebell, Peter J, Boegemann, Martin, Merseburger, Axel, Gakis, Georgios, Bedke, Jens, Neisius, Andreas, Thomas, Christian, Hoefner, Thomas, Telekes, Andras, Kosa, Judit Erzsebet, Revesz, Janos, Bodoky, Gyorgy, Csoszi, Tibor, Csejtei, Andras, Geczi, Lajos, Ruzsa, Agnes, Kolonics, Zsuzsanna, Erfan, Jozsef, McDermott, Ray, Bambury, Richard, Sella, Avishay, Frank, Stephen Jay, Kejzman, Daniel, Goldman, Olesya, Rosenbaum, Eli, Peer, Avivit, Berger, Raanan, Rouvinov, Keren, Sarid, David, Fukasawa, Satoshi, Arai, Gaku, Yamaguchi, Akito, Yokomizo, Akira, Takayama, Tatsuya, Kinoshita, Hidefumi, Kikuchi, Eiji, Mizuno, Ryuichi, Fujii, Yasuhisa, Sassa, Naoto, Matsukawa, Yoshihisa, Fujimoto, Kiyohide, Matsubara, Nobuaki, Tanikawa, Toshiki, Tomita, Yoshihiko, Nishimura, Kazuo, Tsujihata, Masao, Oyama, Masafumi, Masumori, Naoya, Kanayama, Hiroomi, Takano, Toshimi, Miura, Yuji, Miyazaki, Jun, Joraku, Akira, Kimura, Tomokazu, Yamamoto, Yoshiaki, Kobayashi, Kazuki, De Wit, Ronald, Aarts, Maureen, Gerritsen, Winald, Los, Maartje, Beerepoot, Laurens, Izmailov, Adel, Gorelov, Sergey Igorevich, Alekseev, Boris Yakovlevich, Semenov, Andrey, Kostorov, Vladimir Anatolyevich, Alekseev, Sergey M, Zyryanov, Alexander, Oschepkov, Vasiliy Nikolaevich, Shidin, Vladimir Aleksandrovich, Vladimirov, Vladimir Ivanovich, Gafanov, Rustem Airatovich, Karlov, Petr Alexandrovich, Anderson, David Brian, Shepherd, Lucinda, Cohen, Graham Lawrence, Rapoport, Bernardo Louis, Ruff, Paul, Lee, Nari, Bae, Woo Kyun, Lee, Hyo Jin, Herranz, Urbano Anido, Rodriguez-Vida, Alejo, Morales Barrera, Rafael, Grande, Enrique, Alonso Gordoa, Teresa, Guma Padro, Josep, Gauna, Daniel Castellano, Arranz, Jose Angel, Munoz Langa, Jose, Sarrio, Regina Girones, Montesa Pino, Alvaro, Juan Fita, Maria Jose, Su, Yu-Li, Lin, Yung-Chang, Su, Wen-Pin, Shen, Ying-Chun, Chang, Yen-Hwa, Huang, Yi-Hsiu, Sriuranpong, Virote, Chansriwong, Phichai, Srimuninnimit, Vichien, Danchaivijitr, Pongwut, Abali, Huseyin, Yavuz, Sinan, Ozyilkan, Ozgur, Sendur, Mehmet Ali Nahit, Ekenel, Meltem, Ozguroglu, Mustafa, Arslan, Cagatay, Gunduz, Seyda, Ozdogan, Mustafa, Birtle, Alison, Powles, Thomas, Huddart, Robert, de Santis, Maria, Zarkar, Anjali, Evans, Linda, Hussain, Syed, DiSimone, Christopher, Muina, Antonio F, Schlegel, Peter, Jhangiani, Haresh S, Harrison, Michael, Slater, Dennis E, Wright, David, Percent, Ivor J, Lin, Jianqing, Hwang, Clara, Mamtani, Ronac, Gupta, Sumati, Bajaj, Madhuri, Galamaga, Robert, Eklund, John, Wallace, James, Shtivelband, Mikhail, Suh, Jason Jung-Gon, Burhani, Nafisa, Eadens, Matthew, Gunturu, Krishna, Burgess, Earle, Wong, John, Chaudhry, Arvind, Van Veldhuizen, Peter, Graff, Stephanie, Thomas, Christian A, Schnadig, Ian D, Carneiro, Benedito, Hussain, Maha, Morgans, Alicia, Fitzharris, John T, Oliff, Ira A, Vuky, Jacqueline, Hauke, Ralph, Baron, Ari, Joshi, Monika, Bolemon, Britt H, Jiang, Peter, Mega, Anthony E, Markus, Maurice, Pfanzelter, Nicklas, Lawler, William Eyre, Cobb, Patrick Wayne, Courtright, Jay G, Jain, Sharad, Doshi, Gurjyot, Gunuganti, Vijay K, Sartor, Oliver Alton, Cole, Scott W, Babiker, Hani, Uchio, Edward M, Drakaki, Alexandra, Mannuel, Heather D, Alva, Ajjai, Guancial, Elizabeth, Fung, Chunkit, Charles, Anthony, Amato, Robert J, Arriaga, Yull, Bowman, Isaac, Ades, Steven, Dreicer, Robert, Yu, Evan, Quinn, David I, Fleming, Mark, Csőszi, Tibor, Özgüroğlu, Mustafa, Géczi, Lajos, Cheng, Susanna Y-S, Oudard, Stephane, Fléchon, Aude, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, and Homet Moreno, Blanca

Published
2021
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44. Association Between the Occurrence and Spectrum of Immune-Related Adverse Events and Efficacy of Pembrolizumab in Asian Patients With Advanced Urothelial Cancer: Multicenter Retrospective Analyses and Systematic Literature Review

Author

Kijima, Toshiki, Fukushima, Hiroshi, Kusuhara, Shota, Tanaka, Hajime, Yoshida, Soichiro, Yokoyama, Minato, Ishioka, Junichiro, Matsuoka, Yoh, Numao, Noboru, Sakai, Yasuyuki, Saito, Kazutaka, Matsubara, Nobuaki, Yuasa, Takeshi, Masuda, Hitoshi, Yonese, Junji, Kageyama, Yukio, and Fujii, Yasuhisa

Published
2021
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47. Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a sub-group analysis of the phase III ARAMIS trial

Author

Uemura, Hiroji, Matsushima, Hisashi, Kobayashi, Kazuki, Mizusawa, Hiroya, Nishimatsu, Hiroaki, Fizazi, Karim, Smith, Matthew, Shore, Neal, Tammela, Teuvo, Tabata, Ken-ichi, Matsubara, Nobuaki, Iinuma, Masahiro, Uemura, Hirotsugu, Oya, Mototsugu, Momma, Tetsuo, Kawakita, Mutsushi, Fukasawa, Satoshi, Kobayashi, Tadahiro, Kuss, Iris, Le Berre, Marie-Aude, Snapir, Amir, Sarapohja, Toni, and Suzuki, Kazuhiro

Published
2021
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