(Melanoma) What Are the Comparison Results of Keytruda vs. Yervoy?

• September 25, 2019
• Read time: 2 minutes

On July 22, 2019, Caroline Robert published in The Lancet "Comparative efficacy and safety of anti-PD-1 antibody Keytruda versus anti-CTLA-4 antibody Yervoy in melanoma patients in the KEYNOTE-006 Phase 3 clinical trial (5-year long-term follow-up analysis)."

The KEYNOTE-006 trial was a multinational, multicenter Phase 3 clinical trial using 1:1:1 randomization. Primary endpoints were progression-free survival and overall survival; secondary endpoint was objective response rate.

• Keytruda group (2-week cycle, Keytruda 10 mg/kg, N=279)
• Keytruda group (3-week cycle, Keytruda 10 mg/kg, N=277)
• Yervoy group (3-week cycle, Yervoy 3 mg/kg, N=278)

Results at a median follow-up of 57.7 months showed that the primary endpoint median progression-free survival was: Keytruda group 8.4 months / Yervoy group 3.4 months. The Keytruda group showed a 43% reduction in progression risk, with significant improvement and a hazard ratio of 0.57.

The other primary endpoint, median overall survival, was: Keytruda group 32.7 months / Yervoy group 15.9 months. The Keytruda group showed a 27% reduction in progression risk, with significant improvement and a hazard ratio of 0.73.

Regarding safety, the incidence of Grade 3–4 adverse events was: Keytruda group 17% (N=96) / Yervoy group 20% (N=50). Serious adverse event incidence was: Keytruda group 14% (N=75) / Yervoy group 18% (N=45). The most common Grade 3–4 adverse events included colitis (Keytruda 2% / Yervoy 6%), diarrhea (Keytruda 2% / Yervoy 3%), and fatigue (Keytruda <1% / Yervoy 1%).

Based on the KEYNOTE-006 trial's 5-year follow-up results, Caroline Robert concluded: In melanoma patients, anti-PD-1 antibody Keytruda monotherapy demonstrated significant improvement in 5-year progression-free survival and 5-year overall survival compared to Yervoy monotherapy.

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Source: Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study. (Lancet Oncol. 2019 Jul 22. pii: S1470-2045(19)30388-2. doi: 10.1016/S1470-2045(19)30388-2.)

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