Array BioPharma announces strategic collaboration with Merck in CRC

Novel combinations of binimetinib and Keytruda to be studied in colorectal cancer patients with microsatellite-stable tumors

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BOULDER, Colo.—We get a lot of news of research and development collaborations in the range from discovery stage through preclinical studies, but here comes some news of a less-frequent catalyst of collaboration news: a clinical trials agreement between Array BioPharma Inc. and Merck & Co. (known as MSD outside the United States and Canada) to investigate the safety and efficacy of Array’s MEK inhibitor, binimetinib, with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in metastatic colorectal cancer patients with microsatellite-stable tumors (MSS CRC).
The collaboration agreement is between Array BioPharma and Merck, but technically is being handled through a subsidiary—in any case, under the agreement the trial will be sponsored by Merck. Additional details of the business side of the deal were not disclosed.
The companies say they are entering into this clinical trial collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as Keytruda, can be enhanced when combined with a MEK inhibitor, such as binimetinib.
“Given the synergistic activity we have seen with our MEK inhibitor when combined with anti-PD-1 therapy in preclinical models, and based on emerging clinical data, we are optimistic that this combination holds great potential for cancer patients,” said Ron Squarer, CEO of Array BioPharma.
The deal terms call for Array and Merck to work together on a trial to investigate the safety and efficacy of the combination of binimetinib with Keytruda in MSS CRC patients. The trial is expected to establish a recommended dose regimen of binimetinib and Keytruda, as well as explore the preliminary antitumor activity of several novel regimens.
Plans call for the study to start during the second half of this year, and results from the trial will be used to determine optimal approaches to further clinical development of these combinations.
Worldwide, colorectal cancer is the third most common type of cancer in men and the second most common in women. The incidence of microsatellite stability in colorectal tumors varies by stage, with nearly 80 percent of early-stage, resectable tumors and approximately 67 percent of advanced, metastatic tumors exhibiting MSS.
Binimetinib is a late-stage small-molecule MEK inhibitor—MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.
Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Speaking of Keytruda, other recent news brings word that the European Commission has approved the drug for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin or who are transplant-ineligible and have failed brentuximab vedotin. The approval allows marketing of Keytruda in all 28 European Union member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
“Today’s approval brings an important new treatment option to patients in Europe with classical Hodgkin lymphoma who have not responded to existing therapies,” said Dr. Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development for Merck Research Laboratories. “This milestone underscores our commitment to evaluating Keytruda in diseases with unmet need facing the hematology community.”
“For patients with classical Hodgkin lymphoma who have not been successfully treated with prior therapies—many of whom are young and have a poor prognosis—there are limited options and treating the disease poses significant challenges,” commented Dr. Pier Luigi Zinzani, an associate professor of hematology in the Institute of Hematology at the University of Bologna. “With this approval, we will now be able to provide these patients with a much-needed new treatment option.”

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