Phase 3 trial evaluating two bladder cancer regimens fails to meet key endpoints
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A randomized phase 3 trial designed to evaluate two experimental first-line treatment approaches for patients with advanced bladder cancer failed to meet its primary endpoints.
The open-label, multicenter DANUBE trial included cisplatin-eligible and cisplatin-ineligible patients with unresectable stage IV bladder cancer.
Researchers assigned patients to one of three first-line regimens: monotherapy with durvalumab (Imfinzi, AstraZeneca), a human monoclonal antibody that binds to PD-L1; a combination of durvalumab and tremelimumab (MedImmune, AstraZeneca), an anti-CTLA-4 monoclonal antibody; or standard chemotherapy. Chemotherapy consisted of cisplatin and gemcitabine, or carboplatin and gemcitabine.
OS among patients assigned durvalumab monotherapy whose tumor cells or tumor-infiltrating immune cells expressed high levels of PD-L1 ( 25%) and OS among patients assigned the durvalumab-tremelimumab combination regardless of PD-L1 expression served as primary endpoints.
The safety profile of durvalumab monotherapy, as well as the durvalumab-tremelimumab combination, appeared consistent with observations in prior studies.
Complete results of the trial will be submitted for presentation at a future medical meeting.
“AstraZeneca remains committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients,” José Baselga, MD, PhD, executive vice president of oncology research and development for AstraZeneca, said in a company-issued press release. “The results from this trial will inform our comprehensive phase 3 development program in bladder cancer. We look forward to the results of the phase 3 NILE trial, also in the first-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease.”