04:35 AM EDT, 04/17/2023 (MT Newswires) -- Merck & Co. (MRK) reported Sunday a "statistically significant and clinically meaningful improvement" in overall survival results from a phase 3 trial investigating Keytruda combined with standard-of-care chemotherapy intended for the first-line treatment of advanced or unresectable biliary tract cancer.
After a median follow-up of 25.6 months, Keytruda plus chemotherapy reduced the risk of death by 17%, compared with chemotherapy alone, the company said. The median overall survival was 12.7 months for the Keytruda regimen versus 10.9 months for chemotherapy alone.
The one-year overall survival rate was 52% for the Keytruda regimen versus 44% for chemotherapy alone; the two-year rates were 24.9% versus 18.1%, respectively.
The results were "generally consistent across subgroups," the company said. The safety profile of Keytruda was "consistent" with that observed in previously reported studies.
The company said it is sharing these results with regulatory authorities worldwide.
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