Merck (NYSE:MRK) has announced that the European Medicines Agency’s Committee for Medicinal Product for Human Use has adopted a positive view recommending KEYTRUDA approval.
EMA’s CHMP approves KEYTRUDA as MSI-H/dMMR cancer treatment
KEYTRUDA is the company’s anti-PD-1 therapy used as a monotherapy for first-line mismatch repair deficient (dMMR) or metastatic microsatellite instability-high (MSI-H) colorectal cancer treatment in adult patients. The CHMP based its recommendation on the Pivotal Phase 3 KEYNOTE-177 study whereby KEYTRUDA demonstrated considerable progressive free survival improvement relative to the standard of care chemotherapy. The investigator’s chemotherapy choice was mFOLFOX6 in combination or without cetuximab or bevacizumab or combination of FOLFIRI with or without cetuximab or bevacizumab.
Vicki Goodman, Merck Research Laboratories’ VP of Clinical research said dMMR/MSI-H colorectal cancer patients in Europe have been accessing only chemotherapy containing treatment regimens in the first-line treatment setup. Unfortunately, these regimens have historically had poor outcomes. Goodman said that this will change with the positive CHMP opinion which reinforces KEYTRUDA’s potential as a new alternative for MSI-H/dMMR colorectal cancer treatment. He added that the approval shows the company’s ongoing commitment to pursuing biomarker research to come up with options addressing the needs of cancer patients with few effective treatment options. #
KEYNOTE-177 data supported KEYTRUDA approval
The company presented KEYNOTE-177 data at the 2020 virtual American Society of Clinical Oncology meeting. The study results were also published in the New England Journal of Medicine.The European Commission will now review CHMP’s recommendation for marketing authorization in the EU and will issue a final decision in Q1 2021.
KEYTRUDA helps in increasing the body’s immune system’s ability to detect and fight cancer cells. The anti-PD-1 therapy is a humanized monoclonal antibody which blocks PD-1 and ligands PD-L1 and PD-L2 interaction thus resulting in activation of T lymphocytes that might affect tumor and healthy cells. Currently, Merck has the biggest immuno-oncology program in the industry with over 1,300 studies evaluating KEYTRUDA in various cancers. The studies seek to understand KEYTRIDA’s role in different cancers and factors that may indicate the potential benefit of the treatment including various biomarkers.