Bristol-Myers Squibb Company (BMY) announced encouraging data from the ongoing phase Ib CheckMate - 039 study on immuno-oncology drug Opdivo (nivolumab, a PD-1 immune checkpoint inhibitor). Data from the study was published in The New England Journal of Medicine.

The CheckMate - 039 study evaluated the use of Opdivo in patients with relapsed or refractory hematological malignancies. In the study, Opdivo demonstrated high levels of response in patients with relapsed or refractory classical Hodgkin lymphoma with an overall response rate of 87% and stable disease in 13% of patients.

The data supports the Breakthrough Therapy designation granted by the FDA to Opdivo for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and being unsuccessfully treated with Seattle Genetics Inc.’s (SGEN) Adcetris (brentuximab).

Opdivo is being studied in several oncology indications, such as, renal cell carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma. We note that Opdivo is already approved in Japan for treating patients with unresectable melanoma.

The candidate is already under review in the U.S. and EU for previously treated advanced melanoma. A response from the FDA is expected by Mar 30, 2015. In the EU, the marketing application has been granted accelerated assessment status by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Opdivo is also under review in the EU for non-small cell lung cancer (:NSCLC). In the U.S., the company initiated a rolling submission for the NSCLC indication. Bristol-Myers expects to complete the rolling submission by the end of this year.

Approval of Opdivo for NSCLC and melanoma indications would strengthen Bristol-Myers’ position in the lucrative as well as highly sought after immuno-oncology space. We expect investor focus to remain on updates regarding the high potential Opdivo.

Bristol-Myers carries a Zacks Rank #3 (Hold). Other well-ranked stocks in the health care sector include Allergan (AGN) and Actavis (ACT). While Allergan carries a Zacks Rank #1 (Strong Buy), AMAG Pharma carries a Zacks Rank #2 (Buy).

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