Merck announces approval of KEYTRUDA in China in combination with chemotherapy

Merck (MRK) announced KEYTRUDA has been approved by the National Medical Products Administration in China in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer. In October 2023, KEYTRUDA in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment for patients with stage II, IIIA or IIIB NSCLC was approved in the U.S. based on results from the KEYNOTE-671 trial. KEYTRUDA plus chemotherapy in the neoadjuvant setting followed by KEYTRUDA as monotherapy after surgical resection significantly improved overall survival, reducing the risk of death by 28% in patients with NSCLC, regardless of PD-L1 expression, versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection. For patients who received the KEYTRUDA-based regimen, median OS was not reached versus 52.4 months for patients who received the chemotherapy-placebo regimen. The KEYTRUDA-based regimen also improved event-free survival, reducing the risk of disease recurrence, progression or death by 42% compared to the chemotherapy-placebo regimen. Adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single agent adjuvant treatment after surgery, were generally similar to those occurring in patients across tumor types receiving KEYTRUDA in combination with chemotherapy.