On February 2, nivolumab (Opdivo®, Bristol-Myers Squibb) became the newest FDA-approved immunotherapy available for patients with bladder cancer, the fifth most commonly diagnosed cancer in the United States.
Nivolumab’s accelerated FDA approval for patients with resistant or recurrent urothelial carcinoma was based on the results of the CheckMate-275 clinical trial. In the single-arm phase II trial, about 20% of the patients benefitted from nivolumab, which targets the PD-1 receptor responsible for halting anti-cancer immune responses.
“As an oncologist, a nearly twenty-percent response rate in advanced and metastatic bladder cancer is extremely encouraging and clinically meaningful in this patient population,” said Jonathan E. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center.
Furthermore, patients whose tumors expressed PD-L1 (the protein that binds the PD-1 receptor) were even more likely to respond to the treatment.
“Most people don’t know how common bladder cancer is … that’s why we are dedicated to raising awareness and supporting research efforts that may offer more treatment options to patients who need them,” said Stephanie Chisolm, director of Education and Research at Bladder Cancer Advocacy Network. “This approval is another exciting step forward for the bladder cancer community and provides needed hope to patients and their families.”
Nivolumab’s accelerated approval makes it the third immunotherapy, and second checkpoint inhibitor immunotherapy, to be approved for bladder cancer. The first was BCG (bacillus-Calmette Guerin), a vaccine originally used against tuberculosis, which CRI’s founding medical and scientific director, Lloyd J. Old, M.D. helped develop. BCG remains a standard of care for the treatment of superficial bladder cancer. The checkpoint inhibitor atezolizumab (TECENTRIQTM, Genentech), which targets the PD-L1 protein that binds to the PD-1 receptor, was also approved for bladder cancer patients back in May 2016.