Bristol-Myers Squibb Company (BMY) gained 8.9% after the company announced encouraging data from the phase II CheckMate – 063 study on immuno-oncology drug Opdivo (nivolumab, a PD-1 immune checkpoint inhibitor). Data from the study will be presented during the Plenary Session at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology.
The single-arm, open-label CheckMate – 063 study evaluated the use of Opdivo as monotherapy in patients suffering from advanced squamous cell non-small cell lung cancer (NSCLC) who have progressed after at least two prior systemic treatments.
It was found by an independent review committee that following approximately 11 months of minimum follow-up, the objective response was 15%. However, the median duration of response was not reached. Approximately 41% of the patients survived for 1 year and median overall survival was 8.2 months.
Currently there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies. The company intends to tap this unmet market need with Opdivo.
Opdivo is already under review in the EU for the NSCLC indication. In the U.S., the company initiated a rolling submission for the NSCLC indication based on results from the CheckMate – 063 study. Bristol-Myers expects to complete the rolling submission by the end of this year. We are pleased with the data from the study and believe that it boosts the chances of the drug’s approval.
The candidate is also 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.
We note that Opdivo is already approved in Japan for treating patients with unresectable melanoma. Following the Japanese approval, Opdivo became the first PD-1 immune checkpoint inhibitor to gain approval. Ono Pharmaceutical has the rights to commercialize the treatment in Japan as per a 2011 agreement with Bristol-Myers.
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. Opdivo is also being studied in other oncology indications, such as, renal cell carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
Bristol-Myers carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include Mallinckrodt (MNK), Allergan (AGN) and Actavis (ACT). While Actavis carries a Zacks Rank #1 (Strong Buy), Allergan and Mallinckrodt carry same rank as Bristol-Myers.
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