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news.Hana Biosciences has announced that the pre-specified response criteria to proceed to full enrollment of 56 patients has been achieved in its pivotal clinical trial of Marqibo for the treatment of adult acute lymphoblastic leukemia in second relapse.
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Five out of the first 20 patients who completed at least one cycle of weekly Marqibo treatment achieved a complete response (CR) or CR without full platelet (CRp) or neutrophil (CRi) recovery based on interim data. Of the five patients, four achieved a CR or CRp and the fifth patient achieved a CRi and underwent subsequent stem cell transplantation (SCT) prior to confirmatory bone marrow examination. In total, three of the five patients underwent potentially curative SCT following Marqibo treatment.
In accordance with the second-stage trial design, at least three CR or CRp among the first 29 evaluable patients were required for the trial to advance to full enrollment. To date, the rALLy trial has dosed 25 patients, five of whom are not yet available for evaluation.
After Hana completes enrollment of the first 29 patients in the rALLy trial, the data will be submitted to the independent data monitoring committee (IDMC). The IDMC will examine the interim safety results of the trial and also focus on logistical issues such as accrual, retention, quality of clinical and laboratory data, and implications of results of external studies.
The primary objective of the rALLy study is to assess the efficacy and tolerability of single-agent, weekly Marqibo with dosing based on actual body surface area without dose capping. Secondary objectives include evaluation of safety, response duration, and survival.
Hana expects to enroll up to 56 evaluable patients in this clinical trial and is aiming for nine or greater complete responses. The rALLy trial is currently being conducted at 30 clinical sites in the US, Canada, Germany, Israel and the UK.
Anne Hagey, vice president and CMO, said: “We continue to believe that Marqibo has the potential to provide a therapeutic advantage for this very sick patient population for whom there are currently no approved or standard therapies. We look forward to completing full enrollment of this trial in the first half of 2009.”