Merck announced that the European Commission (EC) has approved KEYTRUDA, its anti-PD-1 therapy, for use in combination with platinum-containing chemotherapy as a neoadjuvant treatment, followed by KEYTRUDA as monotherapy in the adjuvant setting, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. This significant development marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results and adds to KEYTRUDA’s portfolio as its sixth approval for lung cancer treatments in Europe.
The EC’s approval is grounded in the outcomes from the Phase 3 KEYNOTE-671 trial, which at a median follow-up of 29.8 months, showed that KEYTRUDA plus chemotherapy in the neoadjuvant phase, followed by KEYTRUDA monotherapy post-surgical resection, significantly improved overall survival, reducing the risk of death by 28% compared to the placebo plus chemotherapy regimen. The treatment also notably improved event-free survival (EFS), reducing the risk of disease recurrence, progression, or death by 41% compared with the control group.
Dr. Solange Peters, a leading expert in medical oncology from Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, highlighted the importance of this approval for patients with resectable NSCLC at high risk of recurrence. She stressed the need for early-stage treatment where significant impact can be made, underscoring the potential life-extending benefits demonstrated by the KEYTRUDA-based regimen in the KEYNOTE-671 trial.
The authorization allows the marketing of this KEYTRUDA regimen across all 27 EU member states, as well as in Iceland, Liechtenstein, Norway, and Northern Ireland, adding to KEYTRUDA’s growing list of indications in the EU, now totaling 27. This follows KEYTRUDA’s U.S. approval in October 2023 for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment and continued as a single agent post-surgery.
This latest approval represents a significant advancement in the treatment of NSCLC in Europe, providing patients with a high risk of recurrence an innovative therapeutic option that has demonstrated the potential for extending lives through the KEYNOTE-671 trial’s results.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
