Immunotherapy after surgery provides significant, durable benefit for high-risk bladder patients

Immunotherapy after surgery increased bladder cancer patients’ chance of staying cancer-free compared to patients who received a placebo, according to clinical trial results shared in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2023 Genitourinary Cancers Symposium in February.

Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai, presented three-year follow-up results from the Phase 3 CheckMate 274 trial. Patients on the trial had urothelial cancer of the bladder or upper urinary tract and had tumor features indicating a high risk for recurrence.

“Adjuvant nivolumab became a standard of care based on the initial results of CheckMate 274,” Dr. Galsky said. “These results, showing patients’ continued survival three years out, reinforce adjuvant nivolumab as a standard of care for patients with muscle-invasive urothelial cancer of the bladder or upper urinary tract. Normally, patients with this cancer face a high chance of recurrence, especially within the first three years after surgical removal of the bladder or kidney.”

This new data showed that at approximately three years of follow-up, nivolumab increased these patients’ chance of staying cancer-free after surgery compared to patients who received a placebo. The average length of time before relapse doubled in patients who received nivolumab, which is a monoclonal antibody immune checkpoint inhibitor that harnesses the immune system to fight cancer. For a subset of clinical trial patients who received the immunotherapy, disease-free survival was more than six times that of patients on placebo.

Among the 699 patients in the trial, half received nivolumab, and the other half received a placebo every two weeks for one year. Adjuvant nivolumab versus placebo was not associated with a detriment to quality of life. This trial was conducted with support from Bristol Myers Squibb, the maker of the immunotherapy, in collaboration with ONO Pharmaceutical Company Ltd.

About the Mount Sinai Health System

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.

Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report‘s Best Hospitals, receiving high “Honor Roll” status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children’s Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: It is consistently ranked in the top 20 by U.S. News & World Report‘s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and top 20 in the nation for National Institutes of Health funding and top 5 in the nation for numerous basic and clinical research areas. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.