Merck (New York Stock Exchange:MRK) announced Saturday that its anti-PD-1 therapy Keytruda (pembrolizumab) met the primary endpoint in a Phase 3 trial of chemoradiation in patients with cervical cancer, reducing their mortality risk by 33% as a first-line therapy.
Publication of overall survival (OS) data from In its KEYNOTE-A18 trial, the New Jersey-based drugmaker said patients on the Keytruda-based regimen had an overall 36-month survival rate of 82.6% compared with 74.8% in those who received chemoradiotherapy (CRT) alone.
Merck (MRK) said the improvement in overall survival was statistically significant and clinically meaningful. Keytruda indicated a safety profile consistent with findings from its previous studies and there were no new safety signals.
The study included newly diagnosed patients with high-risk locally advanced cervical cancer who received Keytruda plus CRT or placebo plus CRT.
In July, the company said KEYNOTE-A18 met its other primary endpoint, progression-free survival. Overall survival data were not mature at the time, though there was a favorable trend toward improvement.