Friday, Merck & Co Inc MRK announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, of Keytruda (pembrolizumab) in combination with chemoradiotherapy (CRT) met its primary endpoint of overall survival (OS) for newly diagnosed patients with high-risk locally advanced cervical cancer.
At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, Keytruda, combined with concurrent CRT, showed a statistically significant and clinically meaningful improvement in OS versus concurrent CRT alone.
The U.S. pharma giant says Keytruda plus CRT is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in OS in these patients.
The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
In the U.S., Keytruda has two additional approved indications for cervical cancer.
In July 2023, Merck said the Phase 3 KEYNOTE-A18 trial investigating Keytruda in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy), met one of its primary endpoints of progression-free survival (PFS) for newly diagnosed patients with high-risk locally advanced cervical cancer.
Keytruda, in combination with concurrent chemoradiotherapy, showed a statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone.
Price Action: MRK shares are up 0.61% at $121.23 on the last check Friday.
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