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Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma

Title: Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma
Authors: Bajorin, Dean F.; Witjes, Johannes Alfred; Gschwend, Jürgen Erich; Schenker, M.; Valderrama, Begoña Pérez; Tomita, Yoshihiko; Bamias, A.; Lebret, Thierry; Shariat, Shahrokh F.; Park, Se-Hoon; Ye, Dingwei; Agerbaek, Mads; Enting, Deborah; Mcdermott, Ray S.; Gajate, Pablo; Peer, Avivit; Milowsky, Matthew Ivan; Nosov, Alexander К.; Antonio, João Neif Jr; Tupikowski, Krzysztof; Toms, Laurence; Fischer, Bruce S.; Qureshi, Anila; Collette, Sandra; Unsal-Kacmaz, Keziban; Broughton, Edward; Zardavas, Dimitrios; Koon, Henry B.; Galsky, Matthew David
Contributors: Hôpital Foch Suresnes; UFR Sciences de la santé Simone Veil (UVSQ Santé); Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay; National Institutes of Health, NIH: P30 CA008748 Amgen Bristol-Myers Squibb, BMS Eli Lilly and Company Pfizer Astellas Pharma US, APUS AstraZeneca GlaxoSmithKline, GSK Merck Novartis Roche Gilead Sciences Janssen Biotech Celgene AbbVie Novartis Pharma Regeneron Pharmaceuticals Merck Sharp and Dohme, MSD Chugai Pharmaceutical Ipsen Biopharmaceuticals Clovis Oncology Sanofi Pasteur Bayer Fund, BF Mylan Mirati Therapeutics Bayer HealthCare, BHC Ipsen Fund Eisai Ferring Pharmaceuticals National and Kapodistrian University of Athens Basilea Pharmaceutica Ipsen; Dr. Bajorin reports receiving consulting fees from Bristol Myers Squibb, Fidia Pharma USA, and Merck; Dr. Witjes, receiving lecture fees from Astellas Pharma and consulting fees from Astra-Zeneca, Bristol Myers Squibb, Ferring Pharmaceuticals, Ipsen Bio-pharmaceuticals, Janssen Biotech, Merck, and Sanofi Pasteur; Dr. Gschwend, receiving advisory board fees from Bristol Myers Squibb; Dr. Schenker, receiving grant support from AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer Healthcare, Bristol Myers Squibb, Celgene, Clovis Oncology, Eli Lilly, F. Hoffmann– La Roche, Gilead Sciences, GlaxoSmithKline, Merck, Merck Sharp and Dohme, Mylan, Novartis, Pfizer, Regeneron Pharmaceuticals, and Tesaro; Dr. Valderrama, receiving lecture fees, consulting fees, and travel support from Astellas Pharma and Bristol Myers Squibb, lecture fees and consulting fees from Bayer Healthcare and EUSA Pharma, consulting fees and travel support from F. Hoffmann–La Roche, Ipsen Biopharmaceuti-cals, and Pfizer, consulting fees from Merck, Merck Sharp and Dohme, Novartis Pharma, Pierre Fabre Pharmaceuticals, and Sanofi-Aventis, and lecture fees from Roche; Dr. Tomita, receiving grant support and lecture fees from Astellas Pharma and Takeda Pharmaceutical, lecture fees from Bristol Myers Squibb, Novartis Pharma, and Pfizer, grant support from Chugai Pharmaceutical, and grant support, lecture fees, and consulting fees from Ono Pharmaceutical; Dr. Bamias, receiving grant support, paid to Hellenic Genitourinary Cancer Group, advisory board fees, and lecture fees from Bristol Myers Squibb, grant support, paid to National and Kapodistrian University of Athens, lecture fees, steering committee fees, and advisory board fees from F. Hoffmann–La Roche, advisory board fees and lecture fees from Ipsen Pharma and Merck Sharp and Dohme, grant support, paid to National and Kapodistrian University of Athens, from Jans-sen, and grant support, paid to Hellenic Genitourinary Cancer Group, from Pfizer; Dr. Lebret, receiving travel support from Astellas Pharma, consulting fees from AstraZeneca, Ferring Pharmaceuticals, and Ipsen Fund, and advisory board fees from Bayer Healthcare and Bristol Myers Squibb; Dr. Shariat, receiving advisory board fees, lecture fees, and travel support from Astellas Pharma and advisory board fees and lecture fees from AstraZeneca, Bayer, Bristol Myers Squibb, Cepheid, Ferring Pharmaceuticals, Ipsen Biopharm, Janssen Biotech, Merck, Merck Sharp and Dohme, Olympus Therapeutics, Pierre Fabre Pharmaceuticals, Richard Wolf Medical Instruments, Roche Products, and Sanofi Pasteur; Dr. Enting, receiving travel support from Janssen Biotech, Merck, and Pfizer; Dr. McDermott, receiving advisory board fees from Astellas Pharma, Bayer, Bristol Myers Squibb, Clovis Oncology, F. Hoffmann–La Roche, Ipsen Biopharm, Janssen Biotech, Merck, and Pfizer and clinical trial fees from Regeneron Pharmaceuticals; Dr. Gajate, receiving lecture fees from Bristol Myers Squibb and Pfizer and lecture fees and advisory board fees from Roche; Dr. Peer, receiving consulting fees and lecture fees from AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, F. Hoffmann–La Roche, Merck Sharp and Dohme, and Pfizer; Dr. Milowsky, receiving consulting fees, paid to his institution, from Asieris Pharmaceuticals and serving as a clinical trial investigator for Acerta Pharma, Astellas Pharma, Bristol Myers Squibb, Clovis Oncology, Constellation Pharmaceuticals, Genentech, Incyte, Innocrin, Inovio Pharmaceuticals, Johnson & Johnson Healthcare Systems, Merck, Mirati Therapeutics, Pfizer, Roche, Seagen, Syndax Pharmaceuticals, and X4 Pharmaceuticals; Drs. Toms and Fischer, being employed by and owning stock in Bristol Myers Squibb; Dr. Qureshi, being employed by Bristol Myers Squibb; Ms. Collette and Drs. Unsal-Kacmaz, Broughton, Zardavas, and Koon, being employed by and owning stock options in Bristol Myers Squibb; and Dr. Galsky, receiving consulting fees from Astellas Pharma, Basilea, Bristol Myers Squibb, Dracen Pharmaceuticals, Dragonfly Therapeutics, Genentech, GlaxoSmithKline, Incyte, Janssen Biotech, Merck, Numab Therapeutics, Pfizer, Rappta Therapeutics, and Seattle Genetics and advisory board fees from AstraZeneca. No other potential conflict of interest relevant to this article was reported.; Supported by Bristol Myers Squibb in collaboration with Ono Pharmaceutical. Dr. Bajorin is supported by a grant from the National Institutes of Health (P30 CA008748). The authors received no financial support or compensation for publication of this manuscript.
Source: ISSN: 0028-4793.
Publisher Information: CCSD; Massachusetts Medical Society
Publication Year: 2021
Collection: Université de Versailles Saint-Quentin-en-Yvelines: HAL-UVSQ
Subject Terms: [SDV]Life Sciences [q-bio]
Description: International audience ; BACKGROUND The role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma after radical surgery is not clear. METHODS In a phase 3, multicenter, double-blind, randomized, controlled trial, we assigned patients with muscle-invasive urothelial carcinoma who had undergone radical surgery to receive, in a 1:1 ratio, either nivolumab (240 mg intravenously) or placebo every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed. The primary end points were disease-free survival among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more. Survival free from recurrence outside the urothelial tract was a secondary end point. RESULTS A total of 353 patients were assigned to receive nivolumab and 356 to receive placebo. The median disease-free survival in the intention-to-treat population was 20.8 months (95% confidence interval [CI], 16.5 to 27.6) with nivolumab and 10.8 months (95% CI, 8.3 to 13.9) with placebo. The percentage of patients who were alive and disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo (hazard ratio for disease recurrence or death, 0.70; 98.22% CI, 0.55 to 0.90; P
Document Type: article in journal/newspaper
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/34077643; PUBMED: 34077643
DOI: 10.1056/NEJMoa2034442
Availability: https://hal.science/hal-03287320; https://doi.org/10.1056/NEJMoa2034442
Accession Number: edsbas.D6DFC698
Database: BASE