There is good news for patients with advanced melanoma who received pembrolizumab. Results from a clinical trial after ten years show a sustained overall benefit.1

The clinical trial, KEYNOTE-006, was a Phase 3 trial measuring pembrolizumab (Keytruda), an immunotherapy drug that blocks the T-cell programmed death-1 checkpoint protein (PD-1), compared to ipilimumab (Yervoy), an immunotherapy drug that blocks the cytotoxic T-lymphocyte antigen 4 protein (CTLA-4). Both drugs were used alone for the comparison against each other.

After ten years, 34.0% of patients who received pembrolizumab are surviving, compared to 23.6% for ipilimumab.1 Also, pembrolizumab reduced the risk of death by 29% and doubled the median overall survival time to 32.7 months versus 15.9 months with ipilimumab.2

The study occurred in two phases, the first of which enrolled 834 patients. The KEYNOTE-006 study concluded with primary endpoints for progression-free survival and overall survival. At its conclusion, 333 patients were eligible to transition to the KEYNOTE-587 extension study which would examine long-term follow-up. Two hundred eleven patients enrolled, 159 in the pembrolizumab arm and 52 in the ipilimumab arm.1,2

The data presented at ESMO followed up on the 211 patients for 123.7 months. They continued to show improvements, with median progression-free survival for pembrolizumab being 9.4 months and 3.8 months for ipilimumab.2

The data is a particularly favorable finding of treatment with immunotherapy for advanced melanoma, especially considering survival was dismal before 2011. Additional anti-tumor activity was observed in the patients receiving a second course of pembrolizumab.1

Results show sustained benefit of pembrolizumab and confirm long-term results for patients with advanced melanoma.

References:

1. Robert C, Carlino MS, McNeil C et al. Pembrolizumab vs Ipilimumab for Advanced Melanoma: 10-Year Follow-Up of the Phase 3 KEYNOTE-006 Study. ESMO Congress 2024. Oral presentation presented on September 15, 2024.

2. Merck Press Release. Ten-Year Data for Merck’s KEYTRUDA (pembrolizumab) Demonstrates Sustained Overall Survival Benefit Versus Ipilimumab in Advanced Melanoma. September 15, 2024.