Geron Announces Publication of Analyses Comparing Real World Data to IMbark Phase 2 in Annals of Hematology
Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the publication in the Annals of Hematology of a paper entitled “Favorable Overall Survival with Imetelstat in Relapsed/Refractory Myelofibrosis Patients Compared with Real World Data,” which details statistical analyses comparing data from the Company’s IMbark Phase 2 clinical trial to closely matched Real World Data (RWD).
“Across the multiple analyses presented in the publication, the median overall survival for imetelstat-treated patients in our IMbark Phase 2 clinical trial was consistently more than double than the median overall survival for patients treated with best available therapy (BAT) from RWD. For the imetelstat-treated patients, the median overall survival (OS) was approximately 30 months in comparison to approximately 12 months for BAT-treated patients from RWD,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “We are pleased with the publication of this important work as these analyses provide us further confidence in the use of OS as the primary endpoint for our ongoing confirmatory IMpactMF Phase 3 trial.”
The paper describes several statistical adjustment methods and multiple sensitivity analyses to improve comparability of the data set from the Company’s IMbark Phase 2 trial and RWD to mimic the effect of a randomized trial. The authors note consistency in the hazard ratios and statistical significance observed across the multiple analyses, which suggests a survival benefit associated with imetelstat treatment of MF patients after ruxolitinib failure. While acknowledging the limitations of RWD analyses, the authors conclude that the results of these analyses warrant further prospective evaluation of imetelstat in a Phase 3 setting with OS as a primary endpoint.
“The RWD used in this paper was collected from patients treated with BAT at the Moffitt Cancer Center after they had discontinued treatment from ruxolitinib, a JAK inhibitor,” said Rami Komrokji, M.D., Vice Chair, Department of Malignant Hematology at Moffitt Cancer Center. “There is an urgent and unmet need for treatment options with a novel mechanism of action for MF patients who are relapsed/refractory to JAK inhibitors. The reported favorable OS with imetelstat treatment in this as well as in prior publications in this very poor prognosis MF patient population differentiates imetelstat from other therapeutic agents in development for MF today. We are excited to participate in Geron’s ongoing IMpactMF clinical trial to confirm these data.”