On Tuesday, Merck & Co Inc (NYSE:MRK) announced that the Phase 3 KEYNOTE-689 trial of Keytruda (pembrolizumab), as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma met its primary endpoint of event-free survival (EFS).

KEYNOTE-689 Phase 3 trial is evaluating Keytruda as neoadjuvant treatment then followed by Keytruda in combination with standard-of-care radiotherapy (with or without cisplatin) as adjuvant treatment and then as a maintenance therapy in treatment-naïve patients with newly diagnosed, stage III or IVA resected locally advanced, head and neck squamous cell carcinoma.

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At a pre-specified first interim analysis conducted by an independent Data Monitoring Committee, there was a statistically significant and clinically meaningful improvement in EFS for patients receiving the Keytruda perioperative treatment regimen.

The study also showed a statistically significant improvement in major pathological response (mPR), a key secondary endpoint, for patients in the Keytruda arm compared with adjuvant radiotherapy alone.

The safety profile of Keytruda was consistent with that observed in previously reported studies; no new safety signals were identified.

A trend toward improvement in overall survival (OS), another key secondary endpoint.

The OS results did not reach statistical significance in patients whose tumors were PD-L1 Combined Positive Score (CPS) ≥10 at the time of this first interim analysis.

Due to the statistical testing hierarchy, formal testing was not performed in the CPS ≥1 and intention-to-treat (ITT) populations. OS will be evaluated at the next interim analysis.

In September, Merck released topline data from the KEYFORM-007 Phase 3 study of the fixed-dose combination of favezelimab and pembrolizumab versus the standard of care for pretreated patients with microsatellite-stable metastatic colorectal cancer.

The U.S. drug giant said the study did not meet its primary endpoint of overall survival.

Price Action: MRK stock is down 0.54% at $108.00 at last check Tuesday.

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