Merck stops keytruda prostate cancer trial as results disappoint(Alliance News) - Merck & Co Inc said on Tuesday it will stop the phrase three trial investigating its anti-PD-1 therapy, keytruda, in combination with lynparza for the treatment of prostate cancer.
The New Jersey, US-based pharmaceutical company said it was discontinuing the study at the recommendation of an independent data monitoring committee whose analysis suggested that the combination of keytruda and lynparza did not meet its primary endpoints.
Analysis suggested that the combination did not improve overall survival when compared to the control arm of either abiraterone acetate or enzalutamide, both of which also are prostate cancer treatments. In addition, earlier analysis showed that radiographic progression free survival did show improvement when compared to the same control arm.
The trial was investigating Merck's keytruda in combination with cancer drug lynparza for the treatment of patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide.
Further, Merck explained that the combination was also associated with a higher incidence of grade 3 to 5 adverse events and drug-related serious adverse events, compared to the control arm. A grade 5 adverse event is one resulting in death.
"Merck continues to evaluate the combination of keytruda and lynpraza in a range of cancers, and to research other keytruda-based combinations for patients with advanced prostate cancer," said Roy Baynes, vice senior president & head of global clinical development, chief medical officer at Merck Research Laboratories.
Merck shares were down 0.8% at USD77.20 in the New York pre-market on Tuesday.
By Heather Rydings; heatherrydings@alliancenews.com
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