ASH 2024 | Findings from the ASC4FIRST study: asciminib compared with TKIs in CP-CML
Jorge Cortes, MD, Georgia Cancer Center, Augusta University, Augusta, GA, comments on the results of the ASC4FIRST study (NCT04971226), a pivotal Phase III trial evaluating asciminib in newly diagnosed chronic myeloid leukemia in chronic phase (CP-CML). Dr Cortes highlights that the 96-week results show a significant and sustained benefit of asciminib compared with all approved tyrosine kinase inhibitors (TKIs). This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript
This study is a frontline study of asciminib, patients with newly diagnosed chronic myeloid leukemia chronic phase, and it’s a randomized study of asciminib versus any of the approved tyrosine kinase inhibitors. It included imatinib and second-generation TKIs. An important thing of the design is that the investigators had to decide if the patient was assigned to the control arm before the randomization; they had to decide would they give them imatinib or would they give them a second-generation TKI, so there’s two strata on this study...
This study is a frontline study of asciminib, patients with newly diagnosed chronic myeloid leukemia chronic phase, and it’s a randomized study of asciminib versus any of the approved tyrosine kinase inhibitors. It included imatinib and second-generation TKIs. An important thing of the design is that the investigators had to decide if the patient was assigned to the control arm before the randomization; they had to decide would they give them imatinib or would they give them a second-generation TKI, so there’s two strata on this study. The initial reports with the primary endpoint of major molecular response at 48 weeks had already been reported and it showed a significant benefit; the primary endpoints were met and that has led to the approval of asciminib in this setting in the U.S. What we reported here is the 96 weeks, which was important to see how much those differences were maintaining or not, and what we showed is that the difference in the efficacy major molecular response now at 96 weeks remains or actually has increased in comparison to all the controls against all the TKIs, against imatinib specifically, and although the study is not powered also for a direct comparison versus second-generation TKIs, that difference has also increased and it’s now almost twice what it was before. We also see benefit in MR4s and MR4.5s and the safety profile has remained very good. All the adverse events, nearly all of them are either at the same frequency or less with asciminib compared to imatinib or compared to the second-generation TKIs. Very few patients, far fewer patients have discontinued asciminib for adverse events, for example, than imatinib or second-generation TKIs. So overall, it really solidifies that benefit that we had seen initially and certainly justifies the addition of asciminib as a very valuable tool for patients with newly diagnosed chronic myeloid leukemia.
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Disclosures
Biopath Holdings: Consultancy, Current holder of stock options in a privately-held company, Membership on an entity’s Board of Directors or advisory committees; Ascentage: Research Funding; Rigel: Consultancy; Lilly: Consultancy; Nerviano: Consultancy; Syndax: Consultancy; AbbVie: Research Funding; Pfizer: Consultancy; Novartis: Consultancy, Research Funding; Sun Pharma: Consultancy, Research Funding.
