ASH 2025 | ASC4OPT: asciminib in two dosing schedules in patients with CML resistant or intolerant to 2+ TKIs
In this video, Massimo Breccia, MD, Sapienza University of Rome, Rome, Italy, discusses the 96-week results of the Phase IIIb ASC4OPT trial (NCT04948333) comparing two dosing schedules of asciminib (once or twice daily) in patients with chronic myeloid leukemia (CML) and suboptimal response, resistance, or intolerance to two or more tyrosine kinase inhibitors (TKIs). This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The ASC4OPT is a Phase IIIb trial that enrolls patients that are resistant or intolerant to two or more prior TKIs. They are randomized to a sunitinib, 40mg BID versus 80mg QD, with a possible primary endpoint that is the MMR, so the major molecular response at 48 weeks. And also possible dose escalation in patients who never achieve this response or fade after 48 weeks. So the results show clearly that there are no differences between the two schedules of administration...
The ASC4OPT is a Phase IIIb trial that enrolls patients that are resistant or intolerant to two or more prior TKIs. They are randomized to a sunitinib, 40mg BID versus 80mg QD, with a possible primary endpoint that is the MMR, so the major molecular response at 48 weeks. And also possible dose escalation in patients who never achieve this response or fade after 48 weeks. So the results show clearly that there are no differences between the two schedules of administration. 43.7% of the patients reached the MMR. And in this trial, there’s also an exploratory cohort that enrolled 30 patients with MMR, but true intolerance. And also these patients, 87% were able to maintain the response.
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