GERON provided updated findings from the phase 2/3 IMerge trial, which is assessing single-agent imetelstat in patients with transfusion-dependent myelodysplastic syndromes. In the 32 patients in the overall population, 34% have reached the primary endpoint of transfusion independence lasting at least 8 weeks. Five of these patients achieved transfusion independence lasting at least 24 weeks.
Moreover, the efficacy appeared to be better in patients with no prior exposure to lenalidomde or hypomethylating agents, and in patients with non-del(5q) disease. Toxicity was as expected and manageable. Based on these findings, the researchers recommended continued exploration of imetelstat, with an expansion cohort now having been enrolled to test the drug in these more favorable patients.
Looking forward: This news has been met with some disdain among popular naysayers in the stock-investing crowd. However, I’m not seeing a particularly gray cloud here. These findings clearly show that there is some activity for imetelstat at these doses in this lower-risk cohort, and the signs of efficacy in non-del(5q) are particularly intriguing, given that lenalidomide plus other agents can’t really do much better in this cohort of patients. Recall in my MDS competition article that the pivotal study for lenalidomide yielded a 27% transfusion independence rate, which does not obviously better the 34% observed here.
Jun. 20, 2018