Advanced bladder cancer: add-on atezolizumab delays progression

  • Galsky MD & al.
  • Lancet
  • 16 May 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%.

Limitations

  • Final OS data are pending.