Drug major Merck & Co. Inc. (MRK) announced Friday that KEYTRUDA plus chemotherapy met primary endpoint of progression-free survival or PFS as first-line therapy for advanced or recurrent Endometrial Carcinoma.
Endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and is the most common type of cancer in the uterus.
KEYTRUDA is an anti-programmed death receptor-1 or PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
The company said the Phase 3 NRG-GY018 trial evaluating KEYTRUDA in combination with standard of care chemotherapy, i.e., carboplatin and paclitaxel, met PFS goal against standard of care chemotherapy alone, to treat patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status.
The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies, and no new safety signals were identified.
Merck plans to present trial results at an upcoming medical meeting and to discuss with regulatory authorities.
Ramez Eskander, principal investigator and gynecologic oncologist, University of California, San Diego, said, “In this study, pembrolizumab in combination with carboplatin and paclitaxel resulted in a statistically significant and clinically meaningful improvement in progression-free survival in both the dMMR and pMMR study populations. We look forward to presenting these exciting findings at an upcoming scientific congress.”
The trial was sponsored by the U.S. National Cancer Institute (NCI), part of the National Institutes of Health.
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