Michael Devitt, MD, discusses the recent withdrawals of immunotherapy agents used to treat patients with bladder cancer.
Michael Devitt, MD, a hematologist and oncologist and an assistant professor at the University of Virginia Medical Center, discusses the recent withdrawals of immunotherapy agents used to treat patients with bladder cancer.
An issue with immunotherapy agents that have had their indications voluntarily withdrawn in the bladder cancer paradigm is that they were approved only based on phase 2 clinical trial data, and the phase 3 confirmatory data did not prove to be as promising, Devitt says. However, the agents Devitt uses most in practice, namely pembrolizumab (Keytruda) and atezolizumab (Tecentriq), still have efficacy data that hold up, according to Devitt. For example, second-line pembrolizumab has randomized phase 3 data that support the efficacy of the agent. It is unlikely that immunotherapy options will be removed from the paradigm entirely, Devitt adds.
The withdrawal of some of these agents may also be an economic-driven decision made by some of the pharmaceutical companies, Devitt explains. Many oncologists are familiar with these agents from other indications, and drugs that have been withdrawn may have had a harder time developing a market share, even if they do demonstrate efficacy, Devitt says.
Although it is important to remember and consider negative phase 3 data, immunotherapy still has a place in the bladder cancer treatment paradigm, Devitt concludes.