Merck & Co. said Thursday that Japanese regulators approved five new indications for the anti-PD-1 therapy Keytruda (pembrolizumab), including three expanded uses in advanced non-small-cell lung cancer (NSCLC) and one in melanoma. The Pharmaceuticals and Medical Devices Agency (PMDS) also authorised use of Keytruda in advanced microsatellite instability-high (MSI-H) tumours.
"These five simultaneous approvals…represent a significant achievement that involved extensive collaboration with the Japan [PMDA]," said Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories.
The new lung cancer indications include Keytruda plus pemetrexed and platinum-based chemotherapy for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression, as well as in combination with carboplatin and paclitaxel or nab-paclitaxel for first-line unresectable, advanced/recurrent squamous NSCLC regardless of PD-L1 expression. The drug was also cleared as monotherapy in the first-line setting for PD-L1-positive unresectable, advanced/recurrent NSCLC. Merck said these approvals were supported by results from the Phase III KEYNOTE-189, KEYNOTE-407 and KEYNOTE-042 trials, respectively.
In addition, single-agent Keytruda was cleared as an adjuvant therapy for melanoma based on data from the late-stage EORTC1325/KEYNOTE-054 study. Japanese regulators also approved Keytruda monotherapy for the treatment of advanced/recurrent MSI-H solid tumours, detected using FALCO Biosystems' companion diagnostic, that have progressed after chemotherapy based on findings from the Phase II KEYNOTE-164 and KEYNOTE-158 trials.
Keytruda, which Merck co-promotes in Japan with Taiho Pharmaceutical, was initially approved in the country in 2016 for certain patients with PD-L1-positive unresectable advanced/recurrent NSCLC. The indication was later expanded to include relapsed or refractory classical Hodgkin lymphoma and radically unresectable urothelial carcinoma that has progressed after chemotherapy.
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