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EHA 2026 | Long-term results from KOMET-007: ziftomenib with 7+3 in newly diagnosed NPM1-m or KMT2A-r AML
Amer Zeidan, MBBS, MHS, Yale University and Yale Cancer Center, New Haven, CT, discusses the long-term results from the KOMET-007 trial (NCT05735184), which is investigating the combination of ziftomenib with standard chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Dr Zeidan highlights that the combination of ziftomenib with 7+3 intensive induction was well-tolerated and demonstrated promising efficacy. This interview took place at the 31st Congress of the European Hematology Association (EHA) in Stockholm, Sweden.
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Transcript
I had the pleasure of presenting the data from the KOMET-007 looking at the addition of Ziftomenib to 7 + 3 in a phase 1 trial, a large phase 1 trial that used Ziftomenib in a dose-escalation fashion in combination with 7 plus 3 in patients who were fit to receive intensive chemo and had NPM1 or KMT2A rearranged leukemia. And what we have seen in this trial is that the combination was actually safe...
I had the pleasure of presenting the data from the KOMET-007 looking at the addition of Ziftomenib to 7 + 3 in a phase 1 trial, a large phase 1 trial that used Ziftomenib in a dose-escalation fashion in combination with 7 plus 3 in patients who were fit to receive intensive chemo and had NPM1 or KMT2A rearranged leukemia. And what we have seen in this trial is that the combination was actually safe. So the early mortality, the induction mortality was only 2%. Most of those patients were able to tolerate the therapy without significant grade 3 toxicities. Most of the toxicities that were seen were a reflection of the myelosuppression that we generally see with 7 plus 3. So we did not see evidence of additional myelosuppressive complications. We also saw a very low incidence of grade 3 or higher differentiation syndrome or QTc prolongation, which are toxicities that we look for when we use menin inhibitors. But what was, I think, most interesting is the efficacy. We saw very nice early efficacy early on, and subsequently in this longer follow-up from the study. So the 12-month survival in the NPM1 cohort was 94%. The median survival was not reached. The CR rate was also in the range of 94%. So all of these numbers, I think, are very encouraging, very high rate of MRD negativity. And importantly, the time for count recovery was also in line with 7 plus 3 around 28 days. So I think these data suggest that the combination is safe, is tolerable, and has very good evidence for efficacy. And based on these results, we have an ongoing phase three trial called the KOMET-017, which is exploring seven plus three plus or minus ziftominib, as well as a separate trial within the same protocol that’s looking at Aza-Ven plus or minus Ziftomenib. And hopefully those randomized trials will provide a confirmation for the results we just saw in the phase one trial.
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Disclosures
Consultancy: Kura.
