Merck’s KEYTRUDA Regimen Trial Fails to Meet Primary Endpoint

Merck announced that its KEYNOTE-B21 (ENGOT-en11/GOG-3053) Phase III clinical trial evaluating KEYTRUDA plus chemotherapy in patients with newly diagnosed high-risk endometrial cancer following curative-intent surgery , did not meet its primary endpoint.

Sponsored by Merck, the trial is being carried out in collaboration with the European Network for Gynecological Oncology Trials (ENGOT) groups and the GOG Foundation.

The randomized, double-blind study included 1,095 patients to evaluate adjuvant treatment with KEYTRUDA plus chemotherapy, regardless of radiotherapy status, compared to adjuvant placebo plus chemotherapy, with or without radiotherapy.

The primary endpoints are disease-free survival (DFS) and overall survival (OS), and secondary endpoints include safety.

Based on data from an interim analysis performed by an independent data monitoring committee, the KEYTRUDA regimen did not show improvement in DFS compared to placebo.

The secondary objective of OS was not tested due to lack of superiority in DFS.

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The safety profile of KEYTRUDA was consistent with previous studies with no new safety signals detected.

Full analysis of the trial data is currently underway.

KEYTRUDA has existing approvals in the United States for certain types of advanced endometrial carcinoma.

It is approved in combination with LENVIMA for patients with mismatch repair-proficient advanced endometrial carcinoma (pMMR) after disease progression following systemic therapy.

It is also approved as a monotherapy for patients with mismatch repair-deficient advanced endometrial carcinoma or MSI-H who have undergone advanced post-systemic therapy and are not eligible for curative surgery or radiotherapy.

Merck Research Laboratories Global Vice President of Clinical Development, Dr. Gursel Aktan, said: “While these results are not what we had hoped for, we strive to continue to expand on the established role of KEYTRUDA in carcinoma. of advanced endometrial disease across our approved indications, while progressing rapidly. clinical research evaluating combinations of KEYTRUDA and other investigational candidates, including antibody-drug conjugates, in the treatment of endometrial and other types of gynecologic malignancies.

Earlier this month, Merck announced results from the final analysis of the Phase III KEYNOTE-811 trial of KEYTRUDA plus trastuzumab and chemotherapy to treat gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for human epidermal growth factor receptor 2 (HER2), locally advanced, unresectable or metastatic. .