Merck's Keytruda Approved in Europe for Resectable Non-Small Cell Lung Cancer

Merck announced on Thursday that the European Commission has approved the use of its anti-PD-1 therapy Keytruda in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by monotherapy for resectable non-small cell lung cancer (NSCLC). 

Keytruda already has over half a dozen indications in NSCLC. This new approval applies to resectable NSCLC at high risk of recurrence in adults. According to Merck, this decision from the EC "marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results and represents the sixth approval for Keytruda in lung cancer in Europe." 

Europe’s regulatory body gave approval following results from the Phase III KEYNOTE-671 trial. With just under 30 months of follow up, the regimen significantly improved overall survival, reducing the risk of death by 28%, regardless of PD-L1 status. Treated patients also showed improved event-free survival, with a 41% reduction in risk of disease recurrence, progression or death.

 Despite advancements, lung cancer continues to have the world’s highest mortality rate and accounts for around one in five cancer deaths in the U.S. This approval on Thursday makes it the sixth lung cancer indication added by the EC for Keytruda, with 27 indications overall in Europe. The U.S. approved the same use in October 2023, specifying tumor size of greater than or equal to four centimeters or node positive.

Thursday’s approval allows Merck to market the Keytruda regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

 Keytruda generated $25 billion in sales for Merck in 2023. The cancer drug is forecast to surpass $30 billion in sales by 2026. However, Keytruda faces an impending patent cliff by the end of the decade.

 To help mitigate the effects, Merck is aiming to bolster its oncology platform by exploring combined immunotherapy approaches to enhance its targeted therapies and continuing studies to further expand Keytruda before patent expiration.

 "We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world," said Marjorie Green, head of oncology for Merck Research Laboratories.