Merck & Co. announced Tuesday that a Phase III trial of Keytruda (pembrolizumab) versus Bristol-Myers Squibb's Yervoy (ipilimumab) for the first-line treatment of patients with advanced melanoma met its two co-primary endpoints. According to Merck, the KEYNOTE-006 trial will be stopped early based on the recommendation of the study's independent Data Monitoring Committee.
The trial compared Keytruda to Yervoy in patients with unresectable stage III or IV advanced melanoma with no more than one prior systemic therapy. The study randomised 834 patients to receive Keytruda at a dose of 10 mg/kg every three weeks or every two weeks, or four cycles of Yervoy at a dose of 3 mg/kg every three weeks.
Merck noted that for the co-primary goals of overall survival and progression-free survival, Keytruda demonstrated significant and clinically meaningful improvements versus Yervoy. Secondary trial endpoints include overall response rate, duration of response and safety, with an exploratory analysis for health-related quality of life. The company indicated that the results will be presented at the American Association of Cancer Research (AACR) annual meeting next month.
According to Merck, Keytruda is the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma. The drug was approved by the FDA in September last year for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor.
Meanwhile, the FDA granted accelerated approval to Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) in December last year for the treatment of patients with unresectable or metastatic melanoma who no longer respond to other drugs. For related analysis, see ViewPoints: First in line – Opdivo and Keytruda make their mark in melanoma, but at what cost to sales of Yervoy?
Other companies developing PD-1 inhibitors or similar drugs called PD-L1 inhibitors include AstraZeneca and Pfizer, with analysts expecting the therapies to generate combined annual sales of more than $30 billion by 2025.
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