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May 31, 2017

Array BioPharma and BMS to assess cancer drugs in Phase I/II combination trial

Array BioPharma has entered a strategic clinical research collaboration with Bristol-Myers Squibb (BMS) to evaluate the combination of binimetinib with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen in a Phase I/II clinical trial to treat metastatic colorectal cancer.

Array BioPharma has entered into a strategic clinical research collaboration with Bristol-Myers Squibb (BMS) to evaluate the combination of binimetinib with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen in a Phase I/II clinical trial to treat metastatic colorectal cancer.

Binimetinib is Array’s investigational inhibitor of MEK, which is a protein kinase in the MAPK signalling pathway that reportedly modulates various cellular activities such as proliferation, differentiation, survival and angiogenesis.

Opdivo is an immune checkpoint inhibitor of programmed death-1 (PD-1), while Yervoy is a recombinant, human monoclonal antibody developed to block the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).

The Phase I/II trial is designed to determine recommended dose regimens for further evaluation.

Array BioPharma chief executive officer Ron Squarer said: "Based on emerging data, we 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 remains a challenging tumour where immunotherapy benefits have been limited to a subset of patients."

The trial will also assess the preliminary anti-tumour activity of binimetinib with Opdivo combination and binimetinib combined with Opdivo + Yervoy in patients with microsatellite stable tumours.

Bristol-Myers Squibb senior vice-president and Oncology Development head Fouad Namouni said: "Colorectal cancer remains a challenging tumour where immunotherapy benefits have been limited to a subset of patients.

"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."

Expected to start in the second half of this year, the trial’s findings will be used for further clinical development of the combination therapies.

Binimetinib is also being evaluated in the Phase III COLUMBUS trial for BRAF-mutant melanoma and the Phase III BEACON CRC trial to treat BRAF V600E-mutant colorectal cancer patients.

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