Adding immunotherapy to chemotherapy regimen improves survival in metastatic bladder cancer patients, trial shows

A clinical trial co-led by Mount Sinai researchers is the first to show that using chemotherapy with immunotherapy resulted in improved survival in patients with an advanced type of bladder cancer. The results were simultaneously reported in The New England Journal of Medicine and at the annual meeting of the European Society for Medical Oncology.

The randomized phase 3 trial, named "CheckMate 901," showed significantly improved outcomes in patients who received the immunotherapy nivolumab with a combination of the chemotherapies gemcitabine and cisplatin, compared to those who received the chemotherapy combination alone.

The number of patients who had no evidence of disease after treatment was nearly twice as high in the group that received chemotherapy with nivolumab, a monoclonal antibody immune checkpoint inhibitor that harnesses the immune system to fight cancer.

"No new agent when added to first-line standard-of-care cisplatin-based chemotherapy has improved overall survival in metastatic urothelial carcinoma until now," said Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute, a part of the Tisch Cancer Center at Mount Sinai, and senior author of the publication. "These results support nivolumab plus cisplatin-based chemo as a new standard approach for the treatment of metastatic urothelial cancer."

A total of 608 patients participated in this trial. Both overall survival and progression-free survival were higher in patients on the immunotherapy-chemotherapy regimen after almost three years. The median duration of complete response in those patients was 37.1 months compared to 13.2 months for patients on just chemotherapy.