Bristol-Myers (BMY) Reports Positive Data On Leukemia Drug

 | Dec 12, 2017 06:04AM ET

Bristol-Myers Squibb Company (NYSE:BMY) 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.