Merck announces Keytruda approval in Japan
As previously reported, Merck announced on December 19 that KEYTRUDA, the company's anti-PD-1 therapy, has been approved in Japan for the treatment of certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer in the first- and second-line treatment settings at a fixed dose of 200 mg every three weeks. MSD will manufacture and market KEYTRUDA in Japan and will promote it with Taiho Pharmaceutical Co., Ltd. The Japanese Ministry of Health, Labour, and Welfare approval is supported by findings from both the KEYNOTE-024 and KEYNOTE-010 studies. KEYNOTE-024 is a randomized, open-label, phase 3 study evaluating KEYTRUDA monotherapy at a fixed dose of 200 mg compared to standard of care platinum-containing chemotherapy for the treatment of patients with both squamous and non-squamous metastatic NSCLC. The study enrolled patients who had not received prior systemic chemotherapy treatment for their metastatic disease and whose tumors had high PD-L1 expression with no EGFR or ALK aberrations. KEYNOTE-010 is an open-label, randomized, phase 2/3 trial assessing two doses of KEYTRUDA compared to docetaxel, a standard of care chemotherapy. This study enrolled patients with any level of PD-L1 expression who had progressed following platinum-containing chemotherapy and, if appropriate, targeted therapy for EGFR or ALK genomic tumor aberrations.