KENILWORTH (NJ) (dpa-AFX) - 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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