(ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®. A supplemental biologics license application for nivolumab (Opdivo) as adjuvant therapy for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma has been accepted by the FDA and granted priority review, according to the company responsible for the agent, Bristol Myers Squibb. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc.
CHECKMATE 274 TRIAL FULL
Follow-up with patients in this trial is ongoing.ĭisclosure: For full disclosures of the study authors, visit. Galsky and colleagues in The New England Journal of Medicine. The CheckMate 274 trial showed a significantly and clinically meaningful benefit of adjuvant systemic immunotherapy as compared to placebo, both in the intention to treat population and in patients with PD-L1 expression greater than or equal to 1. Patients were randomly assigned 1:1 to NIVO 240 mg every 2 wk or PBO for 1 year of treatment. These longer-term disease-free survival data presented at the American Urology Association Annual Meeting built upon initial data presented by Dr. Methods: CheckMate 274 is a phase 3, double-blind trial of adjuvant NIVO versus PBO for high-risk muscle-invasive urothelial carcinoma (MIUC) (bladder, ureter, or renal pelvis) after radical resection. Patients with PD-L1–positive tumors had cancer-free rates that were even higher. In CheckMate 274, with a minimum of 11 months’ follow-up, patients who received nivolumab had an approximately 30% lower likelihood of developing cancer recurrence than those who received placebo. Unfortunately for these patients, no consensus has emerged regarding treatments after surgery that might reduce the risk of cancer recurrence. Surgery that removes the bladder or kidney and ureter has been the standard of care for patients with urothelial cancer that has entered surrounding muscle or lymph nodes, but approximately half of these patients later relapse. “Almost 200,000 people die each year of urothelial cancer worldwide, so advances like immunotherapy being used in this manner bring hope.” In this trial involving patients with high-risk muscle-invasive urothelial carcinoma who had undergone radical surgery, disease-free survival was longer with adjuvant nivolumab than with placebo. Galsky, Director of Genitourinary Medical Oncology at Mount Sinai Tisch Cancer Center. “Longer-term follow-up data are important for reinforcing the initial results we published last year demonstrating for the first time that immunotherapy administered after surgery for bladder cancer and other urothelial cancer can decrease the risk of cancer recurrence,” said Dr. In an interim analysis, CheckMate -274 met primary endpoints of disease-free survival in both all randomized patients and in patients whose tumor cells express PD-L1 1 Opdivo has now demonstrated clinically meaningful efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer Bristol Myers Squibb (NYSE: BMY.
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