Merck announces approval of new indications for KEYTRUDA in Japan

Merck announced that the Japanese Ministry of Health, Labor and Welfare, or MHLW, has approved new indications for KEYTRUDA, or pembrolizumab, Merck’s anti-PD-1 therapy, in certain lung and urothelial cancers: KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment, for patients with non-small cell lung carcinoma, or NSCLC, based on results from the Phase 3 KEYNOTE-671 trial; KEYTRUDA in combination with Padcev, or enfortumab vedotin-ejfv, for the first-line treatment of patients with radically unresectable urothelial carcinoma based on results from the Phase 3 KEYNOTE-A39 trial, which was conducted in a research collaboration with Pfizer and Astellas; KEYTRUDA monotherapy in patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy based on results from the Phase 2 KEYNOTE-052 trial. The approval of KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment for patients with NSCLC is based on results from the Phase 3 KEYNOTE-671 trial. The approval of KEYTRUDA in combination with enfortumab vedotin for the first-line treatment of patients with radically unresectable urothelial carcinoma is based on results from the first interim analysis of the Phase 3 KEYNOTE-A39 trial, which evaluated the combination compared to gemcitabine plus cisplatin or carboplatin in 886 chemotherapy-naive patients with radically unresectable urothelial carcinoma. The approval of KEYTRUDA as monotherapy for patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy is based on results from the phase 2 KEYNOTE-052 trial, which evaluated KEYTRUDA monotherapy compared to chemotherapy alone in 370 chemotherapy-naive patients with radically unresectable urothelial carcinoma who were not eligible for any platinum-containing chemotherapy.