Phase 3 trial of atezolizumab for urothelial cancer misses primary endpoint
Click Here to Manage Email Alerts
Adjuvant atezolizumab failed to extend DFS compared with observation among patients with muscle-invasive urothelial cancer, according to topline results of a randomized phase 3 trial released by the agent’s manufacturer.
Urothelial cancer accounts for approximately 90% of bladder cancer cases in the United States. About one-quarter of patients with newly diagnosed bladder cancer have muscle-invasive disease, which is associated with poor prognosis.
Approximately half of patients with muscle-invasive urothelial cancer develop recurrence within 2 years after surgery.
The open-label IMvigor010 study evaluated atezolizumab (Tecentriq, Genentech) — a monoclonal antibody designed to bind with PD-L1 — for patients at high risk for recurrence after resection.
Researchers randomly assigned 809 patients to observation or 1,200 mg atezolizumab via IV on day 1 of each 21-day cycle for 16 cycles.
Results showed no significant improvement in investigator-assessed DFS — the study’s primary endpoint — with atezolizumab.
The agent exhibited a safety profile consistent with that observed in prior studies, and researchers reported no new safety signals.
“Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”
The FDA previously approved atezolizumab for treatment of certain patients with advanced urothelial carcinoma that cannot be removed by surgery. It also is approved for treatment of specific groups of patients with non-small cell lung cancer, small cell lung cancer and triple-negative breast cancer.
Genentech has several phase 3 trials underway or planned to evaluate the agent as treatment for genitourinary, head and neck, breast, skin, gastrointestinal and gynecologic cancers.