Hana Biosciences has completed enrollment of its pivotal Phase 2 rALLy clinical trial for Marqibo (vincristine sulfate liposomes injection) for the treatment of adult acute lymphoblastic leukemia (ALL) in second relapse, enrolling a total of 65 patients.
The company chose to exceed its enrollment target of 56 subjects, which was reached in August 2009, to collect a more robust pharmacokinetic data set in the adult ALL patient population. Patients have been enrolled and dosed at 22 sites in the US, Canada, Germany, and Israel.
In June, during the 44th Annual American Society of Clinical Oncology (ASCO) meeting, Hana presented preliminary data from the Phase 2 rALLy clinical trial, which showed encouraging anti-leukemic activity in a relapsed/refractory adult ALL patient population, enabling several patients to receive a potentially curative stem cell transplant. Data presented at ASCO also showed encouraging preliminary response duration and overall survival data, as well as a predictable safety profile with no unexpected toxicity.
The primary objective of the pivotal Phase 2 rALLy clinical trial is to assess the efficacy of single-agent, weekly Marqibo (2.25mg/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 study 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.
Marqibo is a targeted, optisome encapsulated formulation of vincristine sulfate, which has shown promising anti-cancer activity in patients with ALL, non-hodgkin’s lymphoma, hodgkin’s disease, and melanoma in several clinical trials.
Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations.
Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.