Summary

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• This summary is based on the review of one randomized controlled trial. ^[1]
• In patients with Bacillus Calmette-Guerin (BCG)-unresponsive carcinoma in situ (CIS) with/without papillary disease: Complete response (CR) rates were 82.4% (95% confidence interval [CI], 72.6 to 89.8) with Inlexzo monotherapy, 67.9% (95% CI, 53.7 to 80.1) with Inlexzo plus cetrelimab, and 46.4% (95% CI, 27.5 to 66.1) with cetrelimab monotherapy.
• In patients with BCG-unresponsive high-risk papillary disease-only non-muscle-invasive bladder cancer (NMIBC) receiving Inlexzo monotherapy: Disease-free survival (DFS) rates were 6-month 85.3 % (95 % CI, 71.6 to 92.7), 9-month 81.1 % (95 % CI, 66.7 to 89.7), and 12-month 70.2% (95% CI, 51.6 to 82.8).
• In patients with BCG-unresponsive CIS with/without papillary disease treated with Inlexzo monotherapy: Median duration of response was 25.8 months (95% CI, 8.3 to not estimable).
• BCG-unresponsive CIS with/without papillary disease: Grade >= 3 treatment-related adverse events (AEs) were 37.7% with Inlexzo plus cetrelimab, 12.9% with Inlexzo monotherapy, and 7.1% with cetrelimab monotherapy; serious treatment-related AEs were 15.1% with Inlexzo plus cetrelimab, 5.9% with Inlexzo monotherapy, and 3.6% with cetrelimab monotherapy.
• BCG-unresponsive high-risk papillary disease-only NMIBC receiving Inlexzo monotherapy: Grade >= 3 treatment-related AEs were 13.5%; serious treatment-related AEs were 5.8%.