The European Commission has cleared Keytruda (Pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more.
The combination cut the risk of death by 27% compared to chemo alone in these patients, and helped patients to extend their lives by around 6.9 months to 23 months, according to data reported at this year’s ESMO cancer conference. It also reduced the chances of disease progression or death by 35%.
The US and Japanese regulators approved the Keytruda plus chemo regimen for first-line TNBC treatment earlier this year.
The new approval is the first breast cancer indication for Keytruda in Europe, although elsewhere Merck has already started to expand the label for its cancer immunotherapy in TNBC.
In July, Merck secured FDA approval for the use of Keytruda pre-surgery alongside chemotherapy in the neoadjuvant setting, as well as in the post-surgery (adjuvant) setting as a monotherapy, to prevent tumours from recurring.
The EU approval also consolidates Keytruda’s position in TNBC against its main rival Roche’s Tecentriq (Atezolizumab) – which has also made the cancer a key development target.
Earlier this year, Roche took the surprising decision to withdraw an accelerated FDA approval for Tecentriq in previously-untreated TNBC after a failed trial, even though an FDA advisory committee voted that it should stay on the market for that use.
Tecentriq used in combination with Bristol Myers Squibb’s chemo drug Abraxane (nab-paclitaxel), was the first immuno-oncology agent be approved for TNBC in 2019, but failed a later confirmatory trial.
“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.
Merck & Co., Inc. is an American multinational pharmaceutical company headquartered in Kenilworth, New Jersey. It is named after the Merck family, which set up Merck Group in Germany in 1668. The company does business as Merck Sharp & Dohme (MSD) outside the United States and Canada,
Merck & Co. was established as an American affiliate in 1891. Merck develops and produces medicines, vaccines, biologic therapies and animal health products. It has multiple blockbuster drugs or products each with 2020 revenues including cancer immunotherapy, anti-diabetic medication and vaccines against HPV and chickenpox.