publication date: Apr. 30, 2015

Keytruda Meets PFS, OS Endpoints in Phase III Advanced Melanoma Trial


A phase III study investigating Keytruda patients with advanced melanoma met two primary endpoints, demonstrating improvements in progression-free survival and overall survival compared to Yervoy. The study’s independent data monitoring committee recommended stopping the trial early.

In the trial, named KEYNOTE-006, Keytruda (pembrolizumab) improved PFS by 42 percent and extended overall survival by 34 percent compared to Yervoy (ipilimumab).

Investigators from 16 countries enrolled 834 patients with metastatic melanoma in the clinical trial, and patients were randomly assigned to Keytruda and Yervoy. The study was published online in the New England Journal of Medicine, and was presented at the annual meeting of the American Association for Cancer Research. The trial was sponsored by Merck.

The study randomized patients to receive Keytruda at 10 mg/kg every three weeks (n=277), Keytruda at 10 mg/kg every two weeks (n=279), or first-line treatment of or four cycles of Yervoy at 3 mg/kg every three weeks (n=278). Tumor response was assessed at week 12, then every six weeks thereafter by independent, central, blinded radiographic review and investigator-assessed, immune-related response criteria.

The median PFS for Keytruda was 5.5 months in the two-week group and 4.1 months in the three-week group compared to 2.8 months for Yervoy (HR 0.58, P<0.00001 for the Keytruda groups vs. Yervoy, 95% CI, 0.46-0.72 for the two-week group and 0.47-0.72 for the three-week group, respectively).

The estimated six-month … Continue reading CCL April – Keytruda Meets PFS, OS Endpoints in Phase III Advanced Melanoma Trial

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