European Commission nod to Merck Keytruda for non-small cell lung cancer at high risk of recurrence

This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2023 and was based on results from the Phase 3 KEYNOTE-091 trial. At a median follow up time of 46.7 months, KEYTRUDA demonstrated a clinically meaningful improvement in disease-free survival (DFS) in patients who received adjuvant chemotherapy, reducing the risk of disease recurrence or death by 24% (HR=0.76 [95% CI, 0.64-0.91]). At an earlier prespecified interim analysis, with a median follow-up of 32.4 months, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DFS in the overall population (HR=0.76 [95% CI, 0.63-0.91]; p=0.0014) compared to placebo in patients with NSCLC who are at high risk of recurrence (stage IB [T2a ≥4 centimeters]), II or IIIA by American Joint Committee on Cancer seventh edition (AJCC 7th edition).

“In the unfortunate scenario that non-small cell lung cancer recurs after surgery, most patients have to face limited palliative treatment strategies, underscoring the need to improve treatment outcomes for earlier stages of NSCLC,” said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. “This approval of KEYTRUDA marks the first immunotherapy option approved in the EU for patients with non-small cell lung cancer who are at high risk of disease recurrence following surgery and chemotherapy, regardless of PD-L1 expression.”

This approval allows marketing of this KEYTRUDA regimen in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

“The approval demonstrates our continued progress to help more patients living with certain types of lung cancer in Europe, treating them earlier in their disease when it may be the most impactful,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. “We are proud that in Europe, KEYTRUDA now has five approved indications in non-small cell lung cancer, in both earlier and advanced stages of disease.”