European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adults with non-small cell lung cancer at high risk of recurrence following complete resection and platinum-based chemotherapy.- Merck Inc.
Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, as a monotherapy 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.
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 III 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 greater than 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.”
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