Newly Diagnosed Cervical Cancer Patients - Merck's Blockbuster Drug Keytruda Plus Chemoradiotherapy Improves Overall Survival

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.

Also Read: Merck’s Multi-Billion Cancer Drug Keytruda Improves Disease-Free Survival In Advanced Bladder Cancer After Surgery, Data Shows.

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.

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Price Action: MRK shares are up 0.61% at $121.23 on the last check Friday.

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