Asciminib and pregnancy in CML: Preliminary human data and clinical implications from 47 reported outcomes
Abstract
Asciminib (ASC) is a first-in-class allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI), specifically targeting the myristoyl pocket. It has shown promising efficacy and a favorable safety profile in patients with chronic phase (CP) chronic myeloid leukemia (CML). As ASC use expands, including frontline therapy, clinicians will face complex questions about pregnancy planning and treatment.
Preclinical studies revealed no adverse effects on male or female fertility at exposures equivalent to human dosing, and no increased risk of embryo-fetal harm from paternal exposure. In female rats and rabbits, a low incidence of embryotoxic and teratogenic effects (e.g., cardiac malformations, anasarca) occurred only at high doses, above therapeutic levels.
Given the limited human data on pregnancy during ASC treatment, we aimed to provide an overview of pregnancy outcomes in CML patients with confirmed paternal or maternal ASC exposure.
This analysis includes cases collected from two sources: data provided by the manufacturer upon our request (from clinical trials and post-marketing) and physician reports, encompassing both retrospective and prospective data.
A total of 47 pregnancies were identified: 13 with paternal exposure and 34 with maternal exposure, in 32 women (1 with 2 pregnancies, 1 with twins). In the paternal exposure group, 8 men were receiving ASC as monotherapy at the time of conception, while 5 were treated with ASC in combination with nilotinib or imatinib. Among the…
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