Geron Corporation (NASDAQ:GERN) reported that Janssen Research & Development, LLC has closed the second internal data assessments of IMbark and IMerge, the clinical studies of the imetelstat in lower risk MDS and refractory or relapsed myelofibrosis, correspondingly.
For IMerge, the risk/ benefit profile of imetelstat in the cured subjects supports continued advancement in lower risk MDS. A data package and planned study design refinements are intended to be offered to the FDA.
For IMbark, this report indicate a potential overall survival advantage and clinical benefit associated with imetelstat treatment in refractory or relapsed myelofibrosis; the study will continue unchanged to assess maturing safety and efficacy data, including an evaluation of overall survival.
The details
IMerge is a Phase 2/3 clinical study assessing imetelstat in transfusion dependent subjects with Intermediate-1 or low risk MDS who are refractory to or have relapsed after previous treatment with an ESA. The clinical study is in two parts, where Part 1 is a Phase II, in almost 30 subjects and Part 2 is intended to be a Phase III trial in almost 170 subjects.
Geron reported that the main efficacy objective continues to be the red blood cell transfusion rate lasting minimum 8 weeks. Key secondary objective comprise the red blood cell transfusion independence rate lasting minimum 24 weeks as well as hematologic improvement. Part I of the study is fully registered.
The second internal assessment of IMerge included report from the almost 30 subjects registered in Part 1. Depending on this second internal assessment, the Collaboration’s Joint Steering Committee determined that the safety profile was steady with prior clinical studies of imetelstat in hematologic malignancies. No new safety indications were known.
The benefit/risk profile of drug, including reviews of 8-week as well as 24-week transfusion independence and HI-E response, across numerous MDS sub-types, helps continued advancement in lower risk MDS.