Bladder cancer: atezolizumab safe, effective in real-world study

  • Sternberg CN & al.
  • Eur Urol
  • 22.03.2019

  • von Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Real-world SAUL study shows atezolizumab is tolerable and effective in patients with urinary tract carcinoma, including those with renal impairment or autoimmune diseases.

Why this matters

  • Findings support atezolizumab benefit observed in IMvigor211 study.

Study design

  • Multicenter international open-label phase 3B safety study, SAUL.
  • 997 patients with locally advanced or metastatic urothelial or nonurothelial carcinoma of the urinary tract received atezolizumab.
  • Primary endpoint: safety.
  • Funding: F. Hoffmann-La Roche, Basel, Switzerland.

Key results

  • 35% of patients were ineligible as per IMvigor211 inclusion criteria. 
  • Median duration of follow-up was 12.7 months.
  • 45% of patients experienced grade ≥3 adverse events; most common were fatigue, asthenia, colitis, and hypertension.
  • Median OS was 8.7 (95% CI, 7.8-9.9) months, and PFS was 2.2 (95% CI, 2.1-2.4) months.
  • Median OS was 5.7 months in patients with renal impairment (n=46) and 8.2 months in those with autoimmune disease (n=35).
  • 6-month OS rate was 60% (95% CI, 57%-63%); median objective response rate (ORR) was 13% (95% CI, 11%-16%).
  • In IMvigor211-like patients, median OS was 10.0 (95% CI, 8.8-11.9) months, 6-month OS was 65% (95% CI, 61%-69%), and ORR was 14% (95% CI, 11%-17%).
  • Toxicity-related discontinuation rate was 8%.

Limitations

  • Lack of comparator group.