Merck reports success and failure in late-stage Keytruda trials

Merck & Co. may add another positive Phase 3 clinical trial to the long list of study successes for its Keytruda cancer immunotherapy, reporting on Wednesday that adding the drug to chemotherapy extended survival in patients with an advanced form of bile duct cancer. .

Along with the good news, however, Merck announced that another late-stage trial of Keytruda, along with two other drugs, failed to improve survival and slow tumor growth in patients with a certain type of prostate tumor. The Keytruda regimen was also associated with a higher incidence of side effects and, as a result of both findings, Merck will discontinue the study.

“We are grateful to patients and researchers for their participation in this trial and will continue to advance our clinical development program to evaluate Keytruda-based combinations and new candidates for patients with prostate cancer,” said Scot Ebbinghaus, vice president of clinical research at Keytruda Laboratories. of Merck Research, in a statement about prostate cancer test results.

Merck is conducting two other keytruda interim trials in prostate cancer, as well as another Phase 3 study. And, through its partnership with AstraZeneca, Merck is also studying the companies’ drug Lynparza for the disease.

Merck plans to detail data from both Keytruda trials that will be read out on Wednesday at upcoming physician meetings. In the case of bile duct cancer outcomes, it will also share data with regulators.

This latest study tested Keytruda in combination with standard chemotherapy versus chemotherapy alone in people with advanced or surgically unremovable biliary tract cancer. The study was conducted in the “first-line” setting, meaning that the participants had not been treated before.

According to Eliav Barr, chief medical officer at Merck Research Laboratories, five-year survival rates for patients diagnosed with advanced biliary tract cancer are only 5% to 15%.

If the study results help Merck gain approval for Keytruda in the disease, it would add another indication to the drug’s label, which currently covers use in 19 different types of cancer.

An approval would also mean Keytruda could compete with AstraZeneca’s Imfinzi immunotherapy, which gained US approval for advanced biliary tract cancer last September. Rival drugmaker Roche, meanwhile, is also studying its Tecentriq immunotherapy to treat the tumor type, and recently reported the results of the Phase 2 study.

Of potentially greater importance to Merck are pending results from a study of Keytruda injected subcutaneously in lung cancer. The data could help it get approval for a more convenient formulation of the drug than its current intravenous form, as well as potentially help protect sales after patents expire later this decade.

Merck reports success and failure in late-stage Keytruda trials

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