- Progression free survival (PFS) in previously untreated patients with metastatic urothelial cancer is increased significantly by adding the PD-L1 inhibitor atezolizumab to platinum-based chemotherapy.
- The improvement in PFS was moderate, and overall survival did not cross the prespecified interim efficacy boundary.
Why this matters
- There have been no big improvements in metastasized urothelial cancer since the 1980s.
- This is the largest trial in this indication.
- IMvigor130 is a phase 3 trial with 1213 patients with metastatic urothelial cancer from 35 countries.
- Randomisation to atezolizumab plus platinum-based chemotherapy (Arm A), atezolizumab (Arm B) or placebo plus platinum-based chemotherapy (Arm C).
- Funding: F. Hoffmann-La Roche, Ltd.
- After a median follow-up of 11.8 months, median PFS was 8.2 months in Arm A and 6.3 months in Arm C (HR 0.82; 95% CI 0.70-0.96; P=0.007).
- Median overall survival was 16.0 vs 13.4 months in Arms A and C, respectively (HR 0.83: 95% CI 0.69-1.00; P=0.027).
- Complete response rates were 13%, 6% and 7% in Arms A, B, and C, respectively.
- Withdrawal due to adverse events was 34%, 6%, and 34% in Arms A, B, and C respectively.
- Interim analysis with short follow-up.
- No data on quality of life.