Geron announces new survival data from IMbark study of Imetelsat in MF patients

Geron announced that results from IMbark, a Phase 2 clinical trial of imetelstat treatment in Intermediate-2 or High-risk myelofibrosis, or MF, patients who are relapsed or refractory to a Janus Kinase inhibitor, were presented at the 60th American Society of Hematology Annual Meeting in San Diego, California. Geron CEO John A. Scarlett said: “The IMbark results suggest a meaningful survival outcome in this poor-prognosis, relapsed/refractory MF patient population where there are currently no approved treatmentWe plan to explore potential late-stage development opportunities for imetelstat in MF through discussions with experts in MF and regulatory authorities and expect to provide a decision regarding future development of imetelstat in this patient population by the end of the third quarter of 2019.” IMbark is a Phase 2 clinical trial that evaluated two starting dose levels of imetelstat in more than 100 patients with Intermediate-2 or High-risk MF who have relapsed after or are refractory to prior treatment with a JAK inhibitor. The oral presentation highlighted efficacy and safety data from the primary analysis, as well as overall survival data with a clinical cutoff of October 22, 2018 and a median follow up of approximately 27 months. The new data presented at ASH indicate that median overall survival for the 9.4 mg/kg dosing arm was 29.9 months, which suggests a meaningful survival outcome with imetelstat treatment in this poor-prognosis patient population, all of whom met rigorous criteria for having failed or not responded to JAK inhibitor treatment prior to enrollment in the trial. Other observational studies of similar patient populations published in medical literature have reported median OS ranged from approximately 12-14 months. The safety profile reported for imetelstat-treated patients in IMbark was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events which were predictable, manageable and reversible.
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