ASH 2025 | A Phase II trial of asciminib for newly diagnosed chronic myeloid leukemia
Fadi Haddad, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses results from a Phase II trial (NCT06236724) evaluating asciminib in patients with newly diagnosed chronic myeloid leukemia (CML). Dr Haddad reports high rates of early molecular and cytogenetic responses with a generally favorable safety profile, supporting asciminib as a promising frontline option. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
And now I’m going to discuss the results of our investigator-initiated Phase II trial of asciminib in patients who have newly diagnosed chronic myeloid leukemia. In total, we enrolled 40 patients at the time of the data cutoff and presentation of this dataset. Overall, those patients, maybe 20% of them, 18% to be specific, had high-risk disease. And those patients received a similar 80 milligrams per day...
And now I’m going to discuss the results of our investigator-initiated Phase II trial of asciminib in patients who have newly diagnosed chronic myeloid leukemia. In total, we enrolled 40 patients at the time of the data cutoff and presentation of this dataset. Overall, those patients, maybe 20% of them, 18% to be specific, had high-risk disease. And those patients received a similar 80 milligrams per day. And we had a median follow-up of one year so far on the study. The primary endpoint of the study was the rate of major molecular response, MMR, or a disease level by PCR less than 0.1%, which was really good. 69% of the patients did achieve MMR by 12 months of therapy. 96% of the patients achieved a complete cytogenetic response by one year of therapy, which is excellent. And close to a third of the patients achieved a deep molecular response by one year of therapy. And this is very promising because this is a surrogate for potentially treatment-free remission and treatment discontinuation down the road. Overall, treatment was well-tolerated. People complained of some fatigue, had some elevation of lipase and amylase, which were overall well-tolerated, of grade one and two. Five patients on this study had to discontinue treatment because of side effects. Two of them because of clinical pancreatitis, one of them after losing a cytogenetic response, and two of them because of cardiovascular toxicities, brain stroke, and cardiovascular syndrome. The cardiovascular syndrome occurred in an older patient, a 72-year-old patient, and this was a grade five event. Other than that, patients remain so far on study with side effects that are manageable and overall of low grade. So in summary, this interim analysis showed a major molecular response rate close to 70% by one year, deep molecular response close to 30% by one year, an overall favorable safety profile. However, some events were reported, particularly two cardiovascular events and two GI toxicities.
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