Regardless of dosing schedule, pembrolizumab demonstrated superior overall survival (OS) in comparison to ipilimumab in treating patients with advanced melanoma, according to a study published in The Lancet.1
An interim analysis of the phase 3 KEYNOTE-006 study (ClinicalTrials.gov Identifier: NCT01866319) suggested that pembrolizumab may have significantly improved outcomes compared with ipilimumab, including OS, progression-free survival (PFS), and objective response rate (ORR).
Researchers enrolled 811 patients with advanced melanoma and randomly assigned them to 3 arms to receive intravenous (IV) pembrolizumab 10 mg/kg every 2 or 3 weeks, or IV ipilimumab 3 mg/kg every 3 weeks for 4 doses.
The final analysis revealed that at median follow-up of 22.9 months, 383 patients had died. Median OS was not reached in the treatment arm receiving pembrolizumab every 2 weeks vs 16.0 months in the ipilimumab arm (hazard ratio [HR], 0.68; 95% CI, 0.53-0.87; P = .0009). Median OS was not reached in the treatment arm receiving pembrolizumab every 3 weeks vs 16.0 months in the ipilimumab arm (HR, 0.68; 95% CI, 0.53-0.86; P = .0008).
The 24-month OS rate was 55% in both the 2-week and 3-week arms, and was 43% in the ipilimumab arm.
After the second interim analysis, an external data monitoring committee recommended that pembrolizumab be made available to patients receiving ipilimumab whose disease had progressed despite treatment.
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The study authors concluded that the results of the final analysis “further support the use of pembrolizumab as a standard of care in this patient population.”
- Schachter J, Ribas A, Long GV, et al. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet. 2017 Aug 16. doi: 10.1016/S0140-6736(17)61601-X [Epub ahead of print]