Pembrolizumab Prolongs Overall Survival Compared With Ipilimumab in Melanoma

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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 treatmen
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 treatmen

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.

RELATED: Phase 1/2 Study of 6MHP Vaccine and Ipilimumab for Advanced Melanoma

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.”

Reference

  1. 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] 

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