- 5-year analysis of the phase 1b KEYNOTE-001 study reveals 34% OS and 21% PFS in patients with advanced melanoma treated with pembrolizumab.
Why this matters
- This analysis represents the longest available follow-up data for pembrolizumab.
- Estimated 5-year OS was 34% in all patients and 41% in treatment-naive patients.
- Estimated 5-year PFS was 21% in all patients and 29% in treatment-naive patients.
- Median time to response was 2.8 months; median response duration was not reached.
- 16% of patients achieved complete response, 25% achieved partial response, and 24% achieved stable disease (disease control rate, 65%).
- 86% of patients experienced treatment-related adverse events (TRAEs).
- 17% of patient experienced grade 3/4 TRAEs.
- 10% of patients discontinued because of TRAEs.
- No patients experienced treatment-related death.
- 655 patients with advanced/metastatic melanoma (151 treatment-naive) who received pembrolizumab 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks were included.
- Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
- No control group.