Merck (NYSE: MRK), also known as MSD outside of the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. This recommendation pertains to its use in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by continued monotherapy as adjuvant treatment. The intended recipients of this treatment are adults diagnosed with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
The CHMP’s decision is based on the findings of the Phase 3 KEYNOTE-671 trial. This study demonstrated significant and clinically meaningful improvements in overall survival and event-free survival, the primary endpoints, when comparing neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after surgical resection against neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients. Key eligibility criteria for the trial included patients with previously untreated and resectable NSCLC at high risk of recurrence, regardless of tumor PD-L1 expression.
The next step involves the review of the CHMP’s recommendation by the European Commission for marketing authorization in the European Union (EU). A final decision is anticipated in the first half of 2024.
Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories, expressed optimism about the potential impact of this positive opinion. She highlighted the significance of this development in expanding treatment options for patients with earlier stages of non-small cell lung cancer, irrespective of PD-L1 expression. Merck looks forward to the decision by the European Commission as it continues to advance the application of KEYTRUDA in lung cancer treatment.
In October 2023, KEYTRUDA received approval in the United States for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by continued monotherapy as adjuvant treatment post-surgery. Lung cancer remains a significant global health concern, being the leading cause of cancer-related deaths worldwide. Non-small cell lung cancer accounts for approximately 80% of all lung cancer cases. Although there have been improvements in survival rates over recent decades, there remains an unmet need for early detection and screening, as a substantial portion of lung cancer cases are diagnosed at advanced stages.
