Merck receives positive CHMP opinion for KEYTRUDA as adjuvant treatment for adults with non-small cell lung cancer

Merck announces that the CHMP has adopted a positive opinion recommending approval of KEYTRUDA (Merck’s anti-PD-1 therapy, for the adjuvant treatment of adults with non-small cell lung cancer) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Results from the Phase 3 KEYNOTE-091 trial demonstrated a statistically significant improvement in disease-free survival  in patients with NSCLC who are at high risk of recurrence, and clinically meaningful results in the patients who received adjuvant chemotherapy. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the fourth quarter of 2023.

“While KEYTRUDA is foundational in the treatment of metastatic non-small cell lung cancer, there continues to be an unmet need to help more patients with lung cancer in earlier stages of disease,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. “The CHMP’s positive recommendation brings us one step closer to providing a new adjuvant treatment option for patients in the European Union with earlier stages of non-small cell lung cancer, regardless of PD-L1 expression.”

 

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Related Topics and Keywords

KEYTRUDA, Merck, non-small cell lung cancer, pembrolizumab