Geron Corp (GERN) Reports First Patient Dosed in IMpactMF Phase 3 Clinical Trial in Refractory Myelofibrosis
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Geron Corporation (NASDAQ: GERN) today announced that the first patient has been dosed in IMpactMF, the Phase 3 clinical trial evaluating imetelstat, a first-in-class telomerase inhibitor, in refractory myelofibrosis (MF).
“As the only study in refractory MF with overall survival as the primary endpoint, dosing of the first patient in IMpactMF is an important step in developing imetelstat as a potential treatment for these patients,” said Aleksandra Rizo, M.D., Ph.D., Geron’s Chief Medical Officer. “With a median overall survival of only approximately 14 – 16 months for patients who fail or no longer respond to JAK inhibitor treatment, there is a significant unmet medical need for therapies that will improve survival.”
IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.
The final analysis for OS is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died (referred to as an event). An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of events for the final analysis have occurred. Under current planning assumptions, the Company expects the interim analysis for IMpactMF to occur in 2024 and the final analysis in 2025. Because these analyses are event-driven, the results may be available at different times than currently expected.
IMpactMF is currently enrolling patients. The Company plans to engage over 180 sites to participate in IMpactMF across North America, South America, Europe, Australia and Asia. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.
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