![]() The company plans to complete a full evaluation of the CheckMate -274 data, work with investigators to present the results at an upcoming medical conference, and submit the data to health authorities. ![]() We would like to thank the patients and investigators who participated in the trial and contributed to our collective scientific understanding.” “With the positive results from CheckMate -274, Opdivo has now demonstrated improved efficacy in the adjuvant treatment of three tumor types, including bladder cancer, melanoma and esophageal/gastroesophageal junction cancer, as part of our broad development program across earlier stages of cancer. “As we advance the science of immunotherapy, we’re discovering that these treatments may play an important role in earlier stages of cancer, when the immune system is generally more intact and potentially more responsive,” said Mark Rutstein, vice president, Opdivo Development, Bristol Myers Squibb. The positive results from CheckMate -274 point to the potential for nivolumab to become a new standard of care in the adjuvant setting, extending disease-free survival for post-surgery patients with muscle-invasive urothelial cancer without the use of chemotherapy.” ![]() “Advances like immunotherapy have helped bring hope to patients across a growing number of cancer types, including previously treated advanced urothelial carcinoma. “With currently available therapies, more than 50% of patients with bladder cancer will experience recurrence after surgery, and each year, the disease takes the lives of nearly 200,000 patients,” said Matthew Galsky, M.D., Professor of Medicine, Director of Genitourinary Medical Oncology, Director of the Novel Therapeutics Unit, and Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. CheckMate -274 is the first and only phase 3 trial in which immunotherapy has reduced the risk of relapse in the adjuvant setting for these patients. Princeton, New Jersey, Saturday, September 26, 2020, 12:00 Hrs īristol Myers Squibb announced that CheckMate -274, a pivotal phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 =1% (programmed death-ligand 1). Follow-up with patients on this trial, which was funded by Bristol Myers Squibb, is ongoing.Bristol Myers Squibb’s phase 3CheckMate -274 trial of Opdivo in patients with high-risk, muscle-invasive urothelial carcinoma meets primary endpoionts Galsky and colleagues in The New England Journal of Medicine. This longer-term disease-free survival data presented at AUA built upon initial data presented by Dr. Patients whose tumors had the gene PD-L1, making them more responsive to nivolumab's cancer-fighting ability, and who received the immunotherapy 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 percent 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, which is why the results presented at AUA are important. 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 with lethal metastatic cancer. "Almost 200,000 people die each year of urothelial cancer worldwide, so advances like immunotherapy being used in this manner bring hope." "Longer-term follow-up data is 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 lead author and presenter Matthew Galsky, MD, Director of Genitourinary Medical Oncology, Mount Sinai Tisch Cancer Center. About 700 patients participated in the phase 3, randomized, double-blind trial, named CheckMate 274 half were given nivolumab and the other half placebo after having surgery with chemotherapy beforehand. The results support giving the immunotherapy nivolumab as an adjuvant treatment-a therapy given after surgery-as standard of care for patients who have muscle-invasive urothelial carcinoma.
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