- The FDA has approved pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
- The recommended dose is 200 mg every 3 weeks.
Why this matters
- Nonresponsiveness to BCG is common in patients with NMIBC, and these patients have limited treatment options.
- Approval was based on multicenter, single-group phase 2 trial KEYNOTE-057.
- 96 patients with high-risk NMIBC who had BCG-unresponsive CIS with or without papillary tumors received pembrolizumab.
- The complete response rate was 41% (95% CI, 31%-51%), and median response duration was 16.2 (0.0+ to 30.4+) months.
- 46% of complete responses lasted ≥12 months.
- The most common adverse reactions (incidence, ≥10%) were fatigue, diarrhea, rash, pruritus, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.
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