Merck's Phase 3 Trial Of KEYTRUDA Plus Chemotherapy In Endometrial Cancer Fails To Meet Primary Goal

(RTTNews) - Drug major Merck & Co., Inc. (MRK) announced Thursday that the Phase 3 KEYNOTE-B21 trial evaluating its anti-PD-1 therapy KEYTRUDA (pembrolizumab), in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival or DFS in patients with newly diagnosed, high-risk endometrial cancer after surgery with curative intent.

KEYNOTE-B21, also known as ENGOT-en11/GOG-3053, is a randomized, double-blind Phase 3 trial sponsored by Merck. The trial enrolled an estimated 1,095 patients.

The company noted that the latest trial results were reported at a pre-specified interim analysis conducted by an independent Data Monitoring Committee. The adjuvant treatment with KEYTRUDA plus chemotherapy, with or without radiotherapy, failed to meet the study's pre-specified statistical criteria for DFS compared to placebo plus adjuvant chemotherapy, with or without radiotherapy.

Merck noted that the study's other primary endpoint of overall survival or OS was not formally tested since superiority was not reached for DFS.

The safety profile of KEYTRUDA was consistent with that observed in previously reported studies, and no new safety signals were identified.

Merck added that a full evaluation of the data from this study is ongoing, and that it will work with investigators to share the results with the scientific community.

In the U.S., KEYTRUDA has two approved indications in endometrial cancer.

Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, said, "While these results were not what we had hoped, we are focused on continuing to build on the established role of KEYTRUDA in advanced endometrial carcinoma through our approved indications, while rapidly progressing clinical research evaluating KEYTRUDA-based combinations and other investigational candidates, including antibody-drug conjugates, in endometrial and other types of gynecologic malignancies."

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