ASH 2024 | A Phase I/Ib dose escalation & expansion study of CPX-351 + gemtuzumab ozogamicin in ND AML
In this video, David Sallman, MD, Moffitt Cancer Center, Tampa, FL, comments on the promising results of a Phase I/Ib trial combining CPX-351 with gemtuzumab ozogamicin in patients with newly diagnosed acute myeloid leukemia (ND AML). He notes that the majority of patients responded to the combination, with almost all patients achieving measurable residual disease (MRD) negativity. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI generated)
Yeah, so we have a trial, it’s actually led by Dr Onyee Chan at our institution, Fort Worth, she led both CPX-gilteritinib and CPX-gemtuzumab studies, an excellent faculty member within our group. But essentially, for frontline, again, CPX clearly better than 7 plus 3, gemtuzumab does add benefit in particular subsets, so really putting these combinations together. So it’s not a huge cohort, but the vast majority, essentially 90% of our patients had responses, almost all of them MRD negative, and outcomes for patients both with and without transplant have been remarkably good...
Yeah, so we have a trial, it’s actually led by Dr Onyee Chan at our institution, Fort Worth, she led both CPX-gilteritinib and CPX-gemtuzumab studies, an excellent faculty member within our group. But essentially, for frontline, again, CPX clearly better than 7 plus 3, gemtuzumab does add benefit in particular subsets, so really putting these combinations together. So it’s not a huge cohort, but the vast majority, essentially 90% of our patients had responses, almost all of them MRD negative, and outcomes for patients both with and without transplant have been remarkably good. So I think if CPX-351 could be further developed from a pivotal strategy, I think we could argue that a randomized trial, looking at CPX-GO versus CPX, again, in P53 wild type, which was required essentially in this trial. And then we’ve done an all-comer risk-based on ELN, but we could look at subsets both in good risk, let’s say NPM1 or core binding factor, where actually our outcomes, again, the patients are really not relapsing from that perspective. Or in the group that’s higher risk, can we further improve outcomes to strategy? There’s going to be another abstract at this congress actually was comparing CPX versus 7 plus 3 plus GO. And actually, there was no major difference. So I think if you’re putting everything together, maybe CPX-GO could be a very exciting combination to look in prospective frontline trials. I think can we get everybody to play together from that perspective as some of these agents are getting a little bit longer in sort of their shelf life from a patent perspective is an interesting question. But we think that the combination is both really well tolerated and quite synergistic. The dose most likely is going to be one day of gemtuzumab, but we’re kind of further optimizing day one or two days of gemtuzumab with the induction cycle of CPX.
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Disclosures
Abbvie: Consultancy; Agios: Consultancy; Axiom: Consultancy; Gilead: Consultancy; Celyad: Consultancy; Froghorn: Consultancy; Incyte: Consultancy; Intellisphere, LLC: Consultancy; Johnson & Johnson: Consultancy; Kite: Consultancy, Membership on an entity’s Board of Directors or advisory committees; Magenta Therapeutics: Consultancy, Membership on an entity’s Board of Directors or advisory committees; NextTech: Consultancy; Novartis: Consultancy, Membership on an entity’s Board of Directors or advisory committees; AvenCell: Membership on an entity’s Board of Directors or advisory committees; Astellas: Membership on an entity’s Board of Directors or advisory committees; BlueBird Bio: Membership on an entity’s Board of Directors or advisory committees; BMS: Membership on an entity’s Board of Directors or advisory committees; Dark Blue Therapeutics: Membership on an entity’s Board of Directors or advisory committees; Intellia: Membership on an entity’s Board of Directors or advisory committees; Jasper Therapeutics: Membership on an entity’s Board of Directors or advisory committees; NKARTA: Membership on an entity’s Board of Directors or advisory committees; Orbital Therapeutics: Membership on an entity’s Board of Directors or advisory committees; Rigel Pharmaceuticals: Membership on an entity’s Board of Directors or advisory committees; Shattuck Labs: Membership on an entity’s Board of Directors or advisory committees; Servier: Membership on an entity’s Board of Directors or advisory committees; Syndax: Membership on an entity’s Board of Directors or advisory committees; Syros: Membership on an entity’s Board of Directors or advisory committees; Apera: Research Funding; Jazz: Research Funding.
