Merck's Keytruda Secures FDA Nod For Head And Neck Cancer As First Immunotherapy For Use Around Surgery

The U.S. Food and Drug Administration (FDA) on Friday approved Merck & Co Inc.’s MRK Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score of at least 1), as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

The approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1).

The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial.

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At the trial’s first pre-specified interim analysis, Keytruda before surgery (neoadjuvant), then continued after surgery (adjuvant) in combination with standard of care (SOC), RT with or without cisplatin, followed by Keytruda alone, reduced the risk of event-free survival (EFS) events (defined as disease recurrence, disease progression, or death) by 30% compared to adjuvant SOC.

Among the CPS ≥1 population, the median EFS was 59.7 months in the Keytruda arm versus 29.6 months in the SOC arm.

“The introduction of Keytruda as a perioperative treatment option for certain patients with resectable locally advanced head and neck squamous cell carcinoma represents a potentially significant shift in how we manage this disease,” the Keynote-689 trial’s principal investigator, Ravindra Uppaluri, said in a statement Friday.

Earlier in June, Merck reportedly approached Swiss biotech MoonLake Immunotherapeutics MLTX with a bid exceeding $3 billion.

The potential deal signals renewed dealmaking activity as investor pressure has mounted on Merck to secure new assets, especially as its blockbuster cancer drug Keytruda faces patent expiration as early as 2028.

In May, Merck’s Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers.

The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.

The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab.

Price Action: MRK stock is trading higher by 0.40% to $82.15 at last check Friday.

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