- The addition of atezolizumab to front-line platinum-based chemotherapy prolonged PFS in patients with advanced urothelial carcinoma.
Why this matters
- There is an unmet clinical need for effective and tolerable therapies for metastatic urothelial carcinoma.
- Almost half of patients with metastatic urothelial carcinoma are ineligible for cisplatin and generally receive carboplatin-based regimens, which show inferior survival vs cisplatin.
- Final PFS and interim OS analysis of multicenter, phase 3 IMvigor130.
- 1213 untreated patients with locally advanced or metastatic urothelial carcinoma were randomly assigned to receive atezolizumab+platinum-based chemotherapy, atezolizumab monotherapy, or placebo+platinum-based chemotherapy.
- 53%-58% of patients were cisplatin-ineligible across the groups.
- Coprimary endpoint: PFS and OS.
- Funding: F. Hoffmann-La Roche; Genentech.
- Atezolizumab+chemotherapy group vs placebo+chemotherapy group:
- Median PFS was significantly longer (8.2 vs 6.3 months; HR, 0.82; P=.007).
- Median OS was 16.0 vs 13.4 months (HR, 0.83; P=.027), but prespecified threshold for statistical significance was not achieved.
- Median OS was not significantly different with atezolizumab vs placebo+chemotherapy.
- Atezolizumab+chemotherapy vs atezolizumab alone vs placebo+chemotherapy group, respectively:
- Objective response rate was 47% vs 23% vs 44%.
- Grade 3/4 adverse event rate was 81% vs 15% vs 81%.
- Toxicity-related discontinuation rate was 11% vs 6% vs 7%.
- Final OS data are pending.