Array Biopharma (ARRY) and Bristol-Myers Squibb (BMY) announced a clinical research collaboration to investigate the safety, tolerability and efficacy of Array’s investigational MEK inhibitor, binimetinib in combination with BMY’s checkpoint inhibitor immunotherapy drug Opdivo (nivolumab) and Opdivo Plus Yervoy (ipilimumab). The combinations are for the potential treatment for metastatic colorectal cancer in patients with microsatellite stable tumors.
According to Ron Squarer, CEO Array BioPharma the decision was made on emerging data, which made the firms believe that “studying combinations of targeted therapies, such as binimetinib, with immuno-oncology agents, such as Opdivo and Yervoy, could provide important scientific advances for patients fighting cancer.”
Colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.4 million new diagnoses in 2012. During this year, around 694,000 deaths were attributed to colorectal cancer. In the U.S. alone, an estimated 135,430 patients will be diagnosed with cancer of the colon or rectum in 2017, and approximately 50,000 are estimated to die of their disease.
Colorectal cancer has been and continues to be a tough to treat cancer. Chekpoint inhibitors benefits have been limited to a subset of patients. Fouad Namouni, senior vice president, head of Oncology Development, Bristol-Myers Squibb stated, “We are committed to investigating a wide range of oncology therapies, and look forward to studying the combination of Array’s MEK inhibitor and our immunotherapies with the goal of developing more treatment options for patients.”
A Phase 1/2 study is expected to establish recommended dose regimens for further study and to explore the preliminary anti-tumor activity of combining binimetinib with Opdivo, as well as binimetinib in combination with the Opdivo + Yervoy regimen.
The first study is anticipated to begin in the second half of 2017. The results will be used to determine optimal approaches to further clinical development of these combinations.
Under the terms of the agreement, Array and Bristol-Myers Squibb will jointly support the study with Array acting as the sponsor.
This collaboration was expected to occur sooner or later. It occurred as soon as good results have emerged from trials with benimetinib. Binimetinib is a MEK inhibitor. MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to cause colorectal cancer as well as many cancers, including melanoma, and thyroid cancers.
It is important to note that Benimetinib 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.
That’s why we believed all along that Array’s drug benimetinib will eventually be tried with immunotherapy drugs in the treatment of colorectal cancer and most probably other cancers.
We are optimistic and hope that the treatment combinations would bring hope to colorectal cancer patients, especially those who did not benefit from previous targeted treatments and checkpoint inhibitors treatments.
Prohost Letter #410 will be posted sooner than usual. It will be brief, adding to the firms presenting at the American Association of Clinical Oncology (ASCO) meeting. It will also Highlight the June PDUFA dates for some of the Prohost Picked Biotech Firms.
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