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Keytruda falls short at Phase 3 in advanced liver cancer

Published on 20/02/19 at 09:51am

MSD has revealed new Phase 3 data which indicates that its blockbuster immunotherapy Keytruda (pembrolizumab), in combination with best supportive care, failed to meet its primary endpoints of overall survival or progression-free survival in the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy.

The company noted that both rates for the Keytruda arm of the study were superior to those in the placebo arm, but these did not reach statistical significance.

Keytruda has already secured FDA approval for the treatment of advanced liver cancer, in patients who have already received Bayer’s Nexavar. These new data could prove problematic for MSD’s efforts to secure further approval in the area. Keytruda generated $7.17 billion of revenue for the company last year.

“While we are disappointed KEYNOTE-240 did not meet its co-primary endpoints, the results for overall survival, progression-free survival and objective response rate are generally consistent with findings from the Phase 2 study, KEYNOTE-224, which led to the accelerated approval of Keytruda for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib,” commented Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer at MSD. “We sincerely thank the patients and investigators for their participation in this study and are committed to helping patients diagnosed with this common and difficult-to-treat type of liver cancer.”

Matt Fellows

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