The European Commission (EC) has granted approval to Merck’s (MSD) Keytruda (pembrolizumab) plus chemotherapy for breast cancer patients.
Keytruda, a humanised monoclonal antibody, secured the approval for the first-line locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) treatment in adults.
It hinders the interaction of programmed death receptor-1 (PD-1) with its PD-L1 and PD-L2 ligands to stimulate T lymphocytes.
The anti-PD-1 treatment can potentially boost the immune system’s ability to find and kill tumour cells.
Keytruda plus chemotherapy is indicated for adult TNBC patients who are PD-L1-positive and have not previously received chemotherapy for metastatic disease.
This is the first time Keytruda is cleared for treating breast cancer in Europe.
The move facilitates the marketing of the combination therapy in all 27 member states of the European Union as well as Iceland, Norway, Lichtenstein and Northern Ireland.
The EC granted the approval based on positive data obtained from the Phase III KEYNOTE-355 clinical trial of Keytruda along with chemotherapy with nab-paclitaxel, paclitaxel or gemcitabine/carboplatin.
In the trial, it was found that the combination treatment substantially boosted overall survival (OS), progression-free survival (PFS).
Additionally, treatment with Keytruda lowered mortality risk by 27% and showed a 34% reduced risk of disease progression or mortality versus chemotherapy alone.
An aggressive kind of breast cancer, TNBC has an increased recurrence rate within the first five years following diagnosis.
Merck Research Laboratories clinical research vice-president Dr Vicki Goodman said: “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.
“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.”
In November last year, Merck obtained the US Food and Drug Administration (FDA) approval for Keytruda plus chemotherapy to treat TNBC patients.