Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblastic Leukemia

Hana Biosciences today announced new positive preliminary efficacy results from a planned interim analysis of the ongoing pivotal rALLy clinical trial evaluating Marqibo(R) (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse. The analysis revealed that nine patients, or 31 percent, 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 ALL patients and catalyze the completion and submission of a New Drug Application for accelerated approval.


"We are strongly encouraged by these excellent preliminary results that show we have already met our overall study goal with regards to the number of complete responses in the first 29 patients, and importantly corroborate previously reported Marqibo activity in past clinical trials," said Steven R. Deitcher, M.D., president and chief executive officer. "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."


"These exciting data bring us another step closer to making this promising treatment available to this very sick ALL patient population for whom there are currently no approved or standard therapies," stated Anne Hagey, M.D., vice president and chief medical officer. "Marqibo may enable high-potency dosing of vincristine chemotherapy and improve efficacy versus standard vincristine without increased toxicity."


Yesterday, Hana Biosciences announced 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 meeting outcome supports an acceptable, manageable safety profile for Marqibo with no new safety concerns. The IDMC has recommended that the trial continue to completion per the protocol. The Company has now accrued greater than 75 percent (43 patients) of the total target enrollment of 56 patients and recruitment is on target to complete by mid-2009.


The primary objective of the rALLy study is to assess the efficacy of single-agent, weekly Marqibo (2.25 mg/m2) with dosing based on actual body surface area without the dose capping applied to standard vincristine. Secondary objectives include evaluation of safety, response duration, and survival. The patient population is defined as Philadelphia chromosome-negative adult patients in second relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation. The rALLy trial is currently being conducted at thirty-one clinical sites in the U.S., Canada, Germany, Israel and the United Kingdom.


Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation from the European Medicines Evaluation Agency in adult ALL.

Source : news.prnewswire.com

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