NEW YORK – Merck said on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for Merck's anti-PD-1 agent pembrolizumab plus chemotherapy for advanced triple-negative breast cancer patients whose tumors express PD-L1 with a combined positive score of at least 10.
The recommendation, which is specifically for TNBC patients who have not received prior chemo, is based on positive overall survival and progression-free survival data from the Phase III KEYNOTE-355 trial comparing the pembrolizumab-chemo combination to chemotherapy alone. In this trial — for which Merck will present updated overall survival data on Sunday during the European Society of Medical Oncology Congress — the immunotherapy combination significantly improved both endpoints.
Both the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency have already approved pembrolizumab plus chemotherapy for this patient population. When Japanese regulators approved the combination last month, they did so based on median progression-free survival of 9.7 months among PD-L1-positive TNBC patients treated with the combination compared to 5.6 months for those on just chemo.
According to a statement from Vicki Goodman, Merck's VP of clinical research, one of the key advantages of this treatment regimen is that pembrolizumab can be combined with different types of chemotherapy agents.
The European Commission will now review the data and CHMP's recommendation and issue a final decision on whether to approve the combination for patients in the EU.