Merck, known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) 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 (NSCLC), who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

The recommendation is based on results from the Phase 3 KEYNOTE-091 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS) in patients with NSCLC who are at high risk of recurrence (stage IB [T2a ≥4 centimeters], II or IIIA), 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.”

The KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP).

In January 2023, KEYTRUDA was approved, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters), II, or IIIA NSCLC in the U.S.