Merck Reports Keytruda Phase 3 Success, Failure

By Colin Kellaher

Merck & Co. on Wednesday reported mixed results from a pair of Phase 3 studies of its blockbuster cancer drug Keytruda.

The Kenilworth, N.J., drugmaker said a study evaluating Keytruda in combination with standard of care chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer.

However, Merck said it is stopping a study of Keytruda in combination with enzalutamide and androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer due to futility. The company said an interim analysis showed the combination didn't demonstrate an improvement in overall survival or radiographic progression-free survival, the trial's dual primary endpoints.

Merck, which is studying Keytruda in a raft of trials across a wide variety of cancers and treatment settings, said it plans to submit the study results in biliary tract cancer to regulatory authorities.

Keytruda, a cancer drug that harnesses a patient's immune system to fight tumors, is approved in dozens of indications around the world and had sales of nearly $15.5 billion for the first nine months of 2022.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

January 25, 2023 07:29 ET (12:29 GMT)

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