Hana Biosciences reports positive efficacy results from leukemia study

Hana Biosciences has announced new positive preliminary efficacy results from a planned interim analysis of the ongoing pivotal rALLy clinical trial evaluating Marqibo for the treatment of adult acute lymphoblastic leukemia in second relapse.

According to Hana, the analysis revealed that nine patients, or 31%, of the first 29 evaluable subjects achieved a complete response (CR) or CR without full blood count recovery (CRi). The estimated median overall survival (OS) in responders was 10.5 months compared to 5.1 months in non-responders at the time of the data cutoff. Because six of the nine CRs were still alive at that time, the median OS in this group may prove to be longer.

Since the outset of the rALLy trial, the target response rate for the study has been 16% complete responses (i.e., CR or CRi), which equates to nine or more out of the target evaluable population of 56 subjects. Completion of rALLy will satisfy the company’s need for greater than 100 Marqibo-treated adult acute lymphoblastic leukemia patients and catalyze the completion and submission of a new drug application for accelerated approval.

Hana Biosciences presented the findings from a planned, pre-specified safety review of data from the rALLy trial conducted by an independent data monitoring committee (IDMC). The IDMC has recommended that the trial continue to completion per the protocol. The company has now accrued greater than 75% (43 patients) of the total target enrollment of 56 patients and recruitment is on target to be completed by mid-2009.

Steven Deitcher, president and CEO of Hana Biosciences, said: These data fully support our plans to submit a new drug application for accelerated approval of Marqibo upon successful completion of rALLy and mark another in a series of milestone achievements in recent months that underscore our ability to execute in terms of product development.