Results from the SAUL study have demonstrated the real-world safety and efficacy of atezolizumab in the treatment of locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract.
The multi-national single-arm safety trial evaluated atezolizumab in a broad, pre-treated population, including patients ineligible for the pivotal IMvigor211 phase 3 trial of atezolizumab.
Between November 2016 and March 2018, 1,004 patients with locally advanced or metastatic urothelial or non-urothelial urinary tract carcinoma who experienced progression during or after one to three prior therapies for inoperable, locally advanced or metastatic disease were enrolled.
Median follow-up was 12.7 months. The median treatment duration was 2.8 months, ranging from 0 to 19 months.
Median overall survival (OS) was 8.7 (95% CI 7.8-9.9) months. The six-month OS rate was 60 per cent (95% CI 57%-63%), median progression-free survival was 2.2 (95% CI 2.1-2.4) months and the overall response rate was 13 per cent (95% CI 11%-16%; 3% complete responses).
Eight per cent discontinued treatment because of toxicity. Grade ≥3 adverse events occurred in 45 per cent of patients. The most common grade ≥3 treatment-related adverse events were fatigue, asthenia, colitis and hypertension.
The findings, published in European Urology, are consistent with previous pivotal trials in urothelial carcinoma.