Bristol-Myers Squibb Company (BMY - Free Report) announced positive data from phase II study, CA180-372, on Sprycel.
Patients received Sprycel 60 mg/m2tablets or powder for oral suspension, once daily, in addition to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone for two years or until the occurrence of unacceptable toxicity in the ongoing CA180-372 (NCT01460160) study.
The study evaluated Sprycel in pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) when added to a chemotherapy regimen. The combination demonstrated an event-free survival rate, the study’s primary endpoint, of 65.5% and an overall survival rate of 91.5% after three years.
Meanwhile, patients who had minimal residual disease (MRD) ≥0.05% at the end of the first block of treatment and those with MRD 0.005-0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks, were eligible for hematopoietic stem cell transplantation (HSCT) in first remission.
We remind investors that Sprycel was approved in the United States for the treatment of adults with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. Sprycel was also approved for adults with Ph+ ALL who are resistant or intolerant to prior therapy.
The drug is also approved for the treatment of adults with newly diagnosed CP Ph+ CML. Sprycel received FDA approval for the expanded indication for treatment in pediatric patients with CP Ph+ CML in November 2017.
The label expansion should improve sales further.
So far this year, Bristol-Myers’ shares have rallied 11.6% compared with the industry's gain of 20%.
Bristol-Myers’ immuno-oncology Opdivo continues to perform well along with Eliquis and Orencia. The company is looking to expand Opdivo’s label further and recently obtained FDA approval for liver and colorectal cancer. However, Opdivo is currently facing competitive challenges in the United States.
The virology business is also under pressure. The company is also looking to counter generic threat for key drugs through deals and acquisitions. The company recently entered into a deal with AbbVie, Inc. (ABBV - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) .
Zacks Rank & Stock to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
A better-ranked health care stocks is Sucampo Pharmaceuticals (SCMP - Free Report) with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sucampo’s earnings per share estimates have moved up from 97 cents to $1.19 for 2018 over the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 15.63%.
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