MSD, known as Merck in the US and Canada, has received approval from the European Commission (EC) for its anti-PD-1 therapy KEYTRUDA, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The EC’s approval is based on results from the pivotal Phase III KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% compared with chemotherapy. In the trial, treatment with the drug also more than doubled median progression-free survival (PFS) compared with chemotherapy
The approval marks the first gastrointestinal indication for KEYTRUDA in Europe, and makes KEYTRUDA the first anti-PD-1/L1 therapy approved in Europe for these patients. It also allows marketing of KEYTRUDA monotherapy in all 27 EU member states plus Iceland, Lichtenstein, Norway, and Northern Ireland. Following Brexit, in line with the reliance route, this approval is also valid in Great Britain.
Dr Thierry Andre, Professor of Medical Oncology at Sorbonne University, and Head of the Medical Oncology Department at St. Antoine Hospital, Assistance Publique Hôpitaux de Paris, said: “Before the KEYNOTE-177 trial, conventional chemotherapy with targeted therapy was the standard of care for patients with metastatic colorectal cancer who have tumors that are MSI-H/dMMR.
“With this approval, patients with metastatic colorectal cancer that is MSI-H or dMMR status will gain a monotherapy treatment option that has shown superior progression-free survival compared to standard of care chemotherapy.”
Dr Scot Ebbinghaus, Vice President of Clinical Research of Merck Research Laboratories, said: “This decision by the European Commission, which was based on the important findings from KEYNOTE-177, exemplifies our commitment to using biomarkers such as MSI/MMR to help identify patients who are most likely to respond to KEYTRUDA.
“Our efforts in biomarker-driven research across tumour types – including colorectal cancer, the most common type of gastrointestinal cancer – will continue to help us bring new options to patients across the globe.”
Darcy Jimenez
This is a syndicated feed from Pharmafile
