On Friday, a European agency adopted two positive opinions for Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab).
One opinion recommends approval of a new subcutaneous (SC) administration route and a solution for injection formulation. If approved, Keytruda SC could be administered in one minute every three weeks (395 mg) or two minutes every six weeks (790 mg).
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What Happened: The positive take from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) applies to all KEYTRUDA indications for adult patients in Europe.
The marketing authorization application for Keytruda SC is based on results from the 3475A-D77 trial comparing Keytruda SC and Keytruda administered every six weeks, each with chemotherapy, studied in patients with treatment naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or, ROS1 genomic tumor aberrations.
Why It Matters: The Merck trial showed comparable pharmacokinetic exposure levels between Keytruda SC and traditional Keytruda. Secondary efficacy endpoints, including objective response rate (ORR) and progression-free survival (PFS), were similar for both Keytruda SC with chemotherapy and Keytruda with chemotherapy. The ORR was 45.4% for Keytruda SC and 42.1% for Keytruda.
The second positive opinion recommends Keytruda as a neoadjuvant and adjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). It would be the first perioperative anti-PD-1 treatment option in the EU for patients with resectable LA-HNSCC. This recommendation is based on the pivotal Phase 3 KEYNOTE-689 trial, where the Keytruda-based regimen showed significant improvement in event-free survival (EFS) compared to adjuvant radiotherapy.
The FDA approved Keytruda for resectable LA-HNSCC in June.
What’s Next: The CHMP recommendations will now be reviewed by the European Commission. Merck expects final decisions in the fourth quarter of 2025.
A Biologics License Application (BLA) for subcutaneous pembrolizumab, seeking approval for all previously approved solid tumor indications, is currently under U.S. review, with a PDUFA date of September 23.
Price Action: MRK stock is down 0.40% at $81.20 at the last check on Friday.
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