Dr. Sonpavde on the Need for Phase 3 Data With 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.