ASH 2025 | KOMET-007: ziftomenib in combination with venetoclax and azacitidine in R/R AML

So at this conference, we are presenting a cohort of the KOMET-007 study that looked at the combination of the menin inhibitor, ziftomenib, with venetoclax and azacitidine in patients with relapse and refractory NPM1 AML. Now, as you know, ziftomenib has been in the news lately. It was recently approved in the U.S. on November 13th for monotherapy of relapsed and refractory NPM1 mutant patients. But the overall response rate was only about 35%. So obviously looking for the next step for our relapsed and refractory patients. In this study, we looked at 40 or 50 patients and we treated them with the maximum tolerated dose of ziftomenib, which is the standard dose that’s approved, plus venetoclax and azacitidine. Patients had a median of one or two cycles of therapy. They had an ECOG performance status of zero to two. And we looked at first at safety, as well as in this phase one, phase two, at efficacy. What we found is that overall, we were having response rates of 55% in these patients, and the median overall survival was several months. And we saw that with the median follow-up of 26 months, that patients were, most of 68% of our patients were still alive. This very, very high response rate was also enhanced in patients who did not have prior venetoclax and azacitidine therapy. So for example, patients who had failed 7 plus 3 or intensive chemotherapy, relapsed, they did extremely well. About 14 of these 41 patients went on to subsequent allogeneic stem cell transplantation. And we feel like 60% of these patients had MRD-negative responses. We feel like this regimen is highly active, has more activity in these patients. We would expect to only have a few months of survival and is very well tolerated with no delay in count recovery.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.