The European Commission (EC) has granted approval for Merck (MSD)'s anti-programmed death receptor-1 (PD-1) therapy, Keytruda, plus chemotherapy for two indications in gastrointestinal cancers.
Keytruda plus chemotherapy comprising fluoropyrimidine and platinum is approved as first-line therapy for adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Only patients with tumours expressing PD-L1 will be eligible for the treatment.
Keytruda plus gemcitabine and cisplatin is intended for use as first-line therapy to treat adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
The approvals come after the European Medicines Agency’s Committee for Medicinal Products for Human Use granted positive recommendations for the Keytruda combo for these indications in October and November 2023.
The EC granted the approval based on overall survival (OS) data reported in the Phase III KEYNOTE-859 and KEYNOTE-966 trials.
In the KEYNOTE-859 trial, Keytruda plus chemotherapy boosted OS, lowering mortality risk by 22% versus chemotherapy at 12 months of median follow-up.
Keytruda plus chemotherapy also offered a statistically significant OS improvement, reducing the risk of death by 17% compared with chemotherapy alone in the KEYNOTE-966 trial.
Merck Research Laboratories global clinical development late-stage oncology head and senior vice-president Dr Marjorie Green stated: “Keytruda has shown its potential as an important treatment option in the EU across a number of gastrointestinal cancers, with seven indications based on data from our extensive clinical development programme.
“With these two new approvals of Keytruda-based regimens in advanced HER2-negative gastric and gastroesophageal junction cancer and advanced biliary tract cancer, Merck continues to demonstrate progress in providing treatment options to patients in Europe.”
A humanised monoclonal antibody, Keytruda enhances the immune system’s potential to identify and kill tumour cells.
Currently underway are 1,600 studies of Keytruda for a range of cancers and treatment settings.
Last month, the US Food and Drug Administration approved the company’s Keytruda plus chemotherapy as a first-line treatment in adult gastric cancer patients.
