A phase 3 clinical trial co-led by Mount Sinai researchers is the first to show that immunotherapy after surgery to remove bladder cancer can reduce the risk of relapse for patients who are at high risk of their cancer returning in a deadly metastatic form, according to results published in The New England Journal of Medicine. The immunotherapy nivolumab was used as an adjuvant therapy, which is given after surgery in the hopes of maximizing its effectiveness.
The randomized trial, named “Checkmate 274,” showed that using 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 nearly doubled in patients who received nivolumab, which is a monoclonal antibody immune checkpoint inhibitor that harnesses the immune system to fight cancer.
Surgery that removes the bladder or kidney and ureter is currently the standard of care for patients with urothelial cancer that has entered surrounding muscle or lymph nodes, though half of these patients later relapse with lethal metastatic cancer. Unfortunately for these patients, no consensus has emerged regarding treatments after surgery that might reduce the risk of cancer recurrence.
“These clinical trial results promise to impact standard treatment of patients with urothelial cancer of the kidney, ureter, or bladder by reducing the risk of metastatic recurrence after surgery,” said Matthew Galsky, MD, senior author of the study and Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, Associate Director of Translational Research, and Co-Leader of the Cancer Clinical Investigation Program at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. “Almost 200,000 people die each year of urothelial cancer worldwide, so advances like immunotherapy being used in this manner bring hope.”