The European Commission (EC) has approved MSD’s – known as Merck in the US and Canada – anti-PD-1 therapy Keytruda (pembrolizumab) plus chemotherapy for the first-line treatment of certain triple-negative breast cancer (TNBC) patients.

The approval covers the use of Keytruda in combination with chemotherapy for locally recurrent unresectable or metastatic TNBC in adults whose tumours express PD-L1 and who have not received prior chemotherapy for metastatic disease.

The EC green light comes off the back of the positive results from MSD’s Phase III KEYNOTE-355 trial – in this trial, Keytruda plus chemotherapy reduced the risk of death by 27% and the risk of disease progression or death by 34% compared to chemotherapy alone.

“At Merck, we are committed to improving outcomes for people with difficult-to-treat cancers, such as TNBC, around the world and are proud of this first European approval for Keytruda in a breast cancer setting,” said Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

“Now patients with metastatic TNBC who have tumours that express PD-L1 (CPS ≥10) in Europe have the new option of Keytruda in combination with chemotherapy, a regimen that has shown significant improvement in overall survival. Today marks an important step forward in the treatment of this aggressive disease,” she added.