Merck Study of Keytruda With Chemotherapy in Endometrial Cancer Fails to Meet Endpoint

By Robb M. Stewart

Merck was hit with a setback in its efforts to expand its blockbuster cancer immunotherapy Keytruda after a late-stage study of its use in combination with chemotherapy to treat endometrial cancer failed to meet a key target.

The drugmaker said Thursday its Phase 3 Keynote-B21 trial evaluating Keytruda with chemotherapy as an adjuvant treatment, with or without radiotherapy, didn't meet its primary endpoint of disease-free survival for the treatment of patients with newly diagnosed, high-risk endometrial cancer after surgery with curative intent.

The combination failed to meet the study's pre-specified statistical criteria for disease-free survival compared with placebo plus adjuvant chemotherapy, with or without radiotherapy, Merck said.

It said the study's other primary endpoint of overall survival wasn't formally tested since superiority wasn't reached for disease-free survival. The safety profile of Keytruda was consistent with that observed in previously reported studies and no new safety signals were identified, it said.

Keytruda, one of the world's top-selling drugs, has powered Merck for much of the past decade, and to extend sales the maker has sought to combine Keytruda with other drugs.

Merk said a full evaluation of the data from the latest study is ongoing and it will work with investigators to share the results with the scientific community.

Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, said the company remained focused on continuing to build on the established role of Keytruda in advanced endometrial carcinoma through approved indications while also rapidly progressing clinical research evaluating Keytruda-based combinations and other investigational candidates in endometrial and other types of gynecologic malignancies

Merck said Health Canada had granted approval for Keytruda in combination with gemcitabine-based chemotherapy for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

May 09, 2024 08:15 ET (12:15 GMT)

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