RAHWAY, N.J. - Merck, known as MSD outside the United States and Canada, announced the European Commission's approval of KEYTRUDA, its anti-PD-1 therapy, for a new lung cancer treatment regimen. This marks the first authorization in Europe for an anti-PD-1/L1 therapy in resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.
The approval, which follows a positive recommendation from the Committee for Medicinal Products for Human Use in February 2024, is based on the Phase 3 KEYNOTE-671 trial results.
This trial showed that KEYTRUDA, combined with platinum-containing chemotherapy as a neoadjuvant treatment followed by KEYTRUDA monotherapy as an adjuvant treatment, significantly improved overall survival and reduced the risk of death by 28% in patients with resectable stage II, IIIA, or IIIB NSCLC compared to the placebo plus chemotherapy regimen.
Patients treated with the KEYTRUDA-based regimen experienced a median overall survival that was not reached, compared to 52.4 months for those on the chemotherapy-placebo regimen. Additionally, the KEYTRUDA regimen improved event-free survival, reducing the risk of disease recurrence, progression, or death by 41%, with a median event-free survival of 47.2 months versus 18.3 months for the chemotherapy-placebo regimen.
This approval enables the marketing of KEYTRUDA for this indication across all 27 EU member states, as well as in Iceland, Liechtenstein, Norway, and Northern Ireland. KEYTRUDA now holds six approvals for NSCLC in Europe and 27 indications overall in the EU. In the U.S., KEYTRUDA was approved in October 2023 for similar use in patients with resectable NSCLC.
According to Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department at Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, this approval is a significant milestone for patients with resectable NSCLC at high risk of recurrence, offering a new treatment option with the potential to extend lives.
The KEYNOTE-671 study included 797 patients randomly assigned to receive either KEYTRUDA plus chemotherapy or placebo plus chemotherapy, followed by surgery and continued adjuvant treatment with either KEYTRUDA or placebo.
Lung cancer remains the leading cause of cancer death in Europe, highlighting the importance of treating patients at earlier disease stages. Merck is at the forefront of lung cancer research, with ongoing trials evaluating KEYTRUDA in earlier stages of lung cancer and exploring new combinations with the therapy.
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