Bristol-Myers Squibb Company (BMY - Free Report) announced encouraging results from a phase III study, CheckMate -238, on Opdivo.
CheckMate 238 is an ongoing phase III, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma. Results from the study showed that Opdivo 3 mg/kg led to a significant improvement in recurrence-free survival (RFS) compared to Yervoy (ipilimumab) 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection.
The results from the planned interim analysis showed that Opdivo met its primary endpoint, with a statistically significant improvement of 35% in RFS compared to Yervoy.
In July 2017, the company reported positive results from the same study.
Last week, the company reported positive results from a phase III study that evaluated Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) and met its co-primary endpoint. The study showed superior overall survival compared to current standard of care, Pfizer, Inc.’s (PFE - Free Report) Sutent in intermediate- and poor-risk patients. Based on a planned interim analysis, an independent Data Monitoring Committee recommended that the study must be stopped early.
We note that Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy — classic Hodgkin lymphoma in both the United States (May 2016) and the EU (November 2016). In November 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Label expansion into additional indications might give the product access to a higher patient population and increase the commercial potential of the drug.
However, Bristol-Myers suffered a setback in January 2017 when it decided not to pursue the accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the United States based on a review of available data.
Currently, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck & Co.’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to suffer further loss of market share.
Meanwhile, the FDA put a partial clinical hold on three clinical trials — CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142. The trials are investigating Opdivo-based combinations in patients with relapsed or refractory multiple myeloma.
Bristol-Myers’ stock has gained 7.5% in the year to date against the industry’s 14.5% gain.
The FDA put these studies on hold due to risks identified in Keytruda, another anti–PD-1 agent, in patients with multiple myeloma.
In addition, concerns from AstraZeneca PLC’s (AZN - Free Report) failed study on lung cancer drug Imfinzi loom large on the company’s CheckMate 227 study on Opdivo.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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