Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced achievement of fifty percent enrollment in the Phase 3 IMpactMF clinical trial investigating the Company’s first-in-class telomerase inhibitor, imetelstat, versus best available therapy (BAT) in patients with relapsed/refractory myelofibrosis (MF).

“Reaching fifty percent enrollment in IMpactMF is an important milestone towards the completion of this first-of-its-kind registration-enabling trial, and we are very grateful to all of the investigators, research staff and patients who are participating,” said Faye Feller, M.D., Executive Vice President, Geron’s Chief Medical Officer. “This is the first Phase 3 trial to evaluate overall survival as a primary endpoint in relapsed/refractory MF and is also the first Phase 3 trial investigating a telomerase inhibitor in this patient population. We believe that if IMpactMF confirms the clinical benefits of symptom response and overall survival observed in the Phase 2 IMbark study, that imetelstat could become a standard of care in relapsed/refractory myelofibrosis.”

“Today’s myelofibrosis treatments include JAK inhibitor and JAK inhibitor combination therapies which can improve symptoms and decrease spleen volume. However, once patients fail or no longer respond to JAK inhibitors, which occurs in 75% of patients within 5 years, these heavily pre-treated patients have a dismal median overall survival of only approximately 14 – 16 months,” said John Mascarenhas, M.D., Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and principal investigator of IMpactMF. “There is therefore a very pressing need for treatments that can improve survival in relapsed/refractory MF. I believe that if IMpactMF reads out positively, hematologists would welcome a new mechanism into their MF armamentarium and would consider overall survival a gold standard clinical outcome.”

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 (MF) who are relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/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 remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.