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European Commission Approves Merck's Keytruda-Chemo Combination for Advanced TNBC Patients

NEW YORK – The European Commission on Friday approved pembrolizumab (Merck's Keytruda) plus chemotherapy for advanced triple-negative breast cancer patients whose tumors express PD-L1 with a combined positive score of at least 10.

The approval, which is for locally advanced or metastatic TNBC patients who have not received prior chemo, comes a month after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that the PD-1 inhibitor be approved for this patient population. This is the first time that Merck has garnered approval for pembrolizumab for a breast cancer indication in Europe.

The European Commission made its decision based on results from the Phase III KEYNOTE-355 trial, in which Merck randomized 847 patients — 38 percent of whom had tumors expressing PD-L1 with combined positive scores of at least 10 — to receive either pembrolizumab plus chemotherapy or chemo alone.

The immunotherapy combination reduced patients' risk of death by 27 percent versus chemotherapy alone. The median overall survival with the pembrolizumab-chemo combination was 23 months versus 16.1 months with chemo alone. The median progression-free survival times were 9.7 months and 5.6 months, respectively.

The pembrolizumab-chemo combination is now available to patients across the EU's 27 member states plus Iceland, Liechtenstein, Norway, and Northern Ireland. Both the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency have also approved the combination for this patient population.