Bristol-Myers Partners Array To Investigate Cancer Candidate

Bristol-Myers Squibb Company (NYSE:BMY) and Array BioPharma (NASDAQ:ARRY) entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Array's binimetinib in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen. The combination will be assessed to treat metastatic colorectal cancer in patients with microsatellite stable tumors.

Bristol-Myers’ shares have lost 7.7% year to date against the Zacks classified Large Cap Pharmaceuticals industry’s gain of 9.1%.

Binimetinib is an investigational MEK inhibitor that is being studied in clinical trials in advanced cancer patients, including the phase III COLUMBUS trial in patients with BRAF-mutant melanoma and the phase III BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.

The phase I/II study is anticipated to begin in the second half of 2017, and the results from this study will be used to determine optimal approaches to advance the development of these combinations. The study will evaluate the preliminary anti-tumor activity of combining binimetinib with Opdivo as well as binimetinib in combination with the Opdivo + Yervoy regimen. Per the agreement, Array and Bristol-Myers Squibb will jointly support the study sponsored by the former.

However, we remind investors that in Mar 2017, Array withdrew its new drug application (NDA) for its binimetinib, from the FDA’s Division of Oncology Products 2. The candidate was being evaluated as a monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.

In fact, the decision to withdraw the NDA was based on thorough discussions with the FDA, following late cycle review meeting held with agency. According to the feedback received from the FDA, the clinical benefit demonstrated in the phase III NEMO study was not sufficient to support the NDA for that indication. Nonetheless, the action will not impact the other ongoing trial on the drug.

Recently, Bristol-Myers also collaborated with Advaxis, Inc. (NASDAQ:ADXS) to evaluate ADXS-DUAL, an investigational immunotherapy targeting HPV-associated cancers, and the former’s Opdivo, as a potential combination treatment option for women with metastatic cervical cancer. The study is expected to start by the end of 2017 and will assess this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic chemotherapy.

Zacks Rank & Stock to Consider

Both Bristol-Myers and Array carry a Zacks Rank #3 (Hold). Another better-ranked stock in the health care sector is VIVUS, Inc. (NASDAQ:VVUS) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.

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