Guru P. Sonpavde, MD, discusses the need for phase 3 data evaluating frontline pembrolizumab or atezolizumab in bladder cancer.
Guru P. Sonpavde, MD, director, Bladder Cancer, and physician, Dana-Farber Cancer Institute, discusses the need for phase 3 data evaluating frontline pembrolizumab (Keytruda) or atezolizumab (Tecentriq) in bladder cancer.
In 2017, the FDA granted single-agent pembrolizumab and atezolizumab accelerated approvals for the frontline treatment of patients with locally advanced or metastatic bladder cancer who are ineligible for cisplatin-containing chemotherapy. The approvals were based off findings from the phase 2 KEYNOTE-052 (pembrolizumab) and IMvigor210 (atezolizumab) trials.
The agents appear feasible in patients with PD-L1–high disease, says Sonpavde. However, phase 3 clinical trials are needed to determine whether the agents are superior to the switch maintenance regimen of gemcitabine/platinum followed by avelumab (Bavencio) maintenance, says Sonpavde.
The switch maintenance approach is backed by positive phase 3 data from the JAVELIN Bladder 100 trial, concludes Sonpavde.