Imetelstat: Additional Ph II IMbark data

Geron said a joint steering committee's second internal review of data from about 100 patients in the open-label, international Phase II IMbark trial "suggest a potential overall survival benefit" for 9.4 mg/kg IV imetelstat dosed every 3 weeks, but did not disclose study data. While high-dose imetelstat led to improvements in anemia, peripheral blood counts and overall symptom scores, the spleen volume response rate was lower than that previously observed in studies of first-line MF treatments. The committee concluded 9.4 mg/kg is an appropriate starting dose for the population, and recommended the study continue without modification. Geron said new enrollment will remain suspended while data matures "because the total number of patients enrolled to date is adequate to assess longer-term outcome measures." The trial enrolled patients with intermediate-2 or high-risk MF who relapsed after or are refractory to prior treatment with a Janus kinase (JAK) inhibitor. ...