Date: 2017-05-08
Type of information: Clinical research agreement
Compound: binimetinib and Keytruda® (pembrolizumab)
Company: Array BioPharma (USA - CO) Merck&Co (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- kinase inhibitor/RAF kinase inhibitor/MEK (MAP kinase) inhibitor/îmmunotherapy product/monoclonal antibody/immune checkpoint inhibitor.
- The RAS/RAF/MEK/ERK pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway.
- Keytruda® (pembrolizumab - MK-3475) is a selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. In April 2013, MK-3475 has received a Breakthrough Therapy designation for advanced melanoma from the FDA. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway.
Disease: colorectal cancer
Details:
- • On May 8, 2017, Array BioPharma announced that it has entered into a clinical trial collaboration agreement with Merck&Co to investigate the safety and efficacy of binimetinib, with Merck's anti-PD-1 therapy, Keytruda® (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors. The companies are entering into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, can be enhanced when combined with a MEK inhibitor.
- Under the terms of the agreement, Array and Merck&Co will collaborate on a clinical trial to investigate the safety and efficacy of the combination of binimetinib with Keytruda® , in metastatic colorectal cancer patients with microsatellite stable tumors patients. The trial is expected to establish a recommended dose regimen of binimetinib and Keytruda® , as well as explore the preliminary anti-tumor activity of several novel regimens. The study is expected to begin in the second half of 2017. Results from this first study will be used to determine optimal approaches to further clinical development of these combinations.
- The collaboration agreement is between Array BioPharma and Merck&Co, through a subsidiary. Under the agreement, the trial will be sponsored by Merck. Additional details of the collaboration were not disclosed.
Financial terms:
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