ASH 2025 | Preliminary human data and clinical implications of asciminib administration during pregnancy in CML

It has been only in the past 10 to a little more years that we are able to support people that want to be pregnant during CML. You need to distinguish between male patients and female patients because of course male patients can have problems with the fertility but usually once there’s the conception it is uncommon that you have a problem due to the drug exposure. While with the female the problem is that you carry the baby in the first part of the pregnancy you expose the baby if you’re taking drugs to the drugs that can interfere with organogenesis and also in the second part of the pregnancy the drug can pass through the placenta and have problems and interfere with the pregnancy and the baby. And besides, you don’t have to forget that those patients are affected by CML and thus stopping or continuing the drug is an important challenge and must be evaluated case-by-case. As the use of asciminib is going to increase, because also in Europe now, other than in the US, it has been approved for the first line, we need to know more about it. So we decided to harvest data as we harvested with the other TKI inhibitors on asciminib. And we asked the help of the company that could give us the access to the reported clinical trial and also other side effects registries that they have access to. And other source of the data were spontaneous report after spreading the word that we were harvesting those cases. And so far we have harvested 47 cases of pregnancy during asciminib, 13 male conceptions and 34 pregnancies, because one was a twin, female conception. With the male conception and pregnancy we didn’t evidence any particular problem. Eight patients were exposed to only asciminib while five patients were exposed to only asciminib, while five patients were exposed to asciminib in combination with dasatinib, nilotinib, or imatinib. In the female part, most of the patients had stopped the drug before the fifth week of gestation, while one patient, maybe two patients, were exposed until the sixth or the ninth week of pregnancy. And one patient was exposed during the second and third trimester because she had to resume therapy, not having responded to interferon. For the female point of view, we didn’t recall particular problem while two patients were reported to have some congenital abnormality and those are actually now object of a major focus. For one that presented with a cardiac malformation unfortunately the follow-up was lost she was exposed for five to six weeks while the other patient was exposed until eight weeks but the malformation that was not reported was not deemed related to asciminib since the patient was taking other drugs that were more likely to produce malformations. So for asciminib also we still recommend contraception and to report any case of accidental exposure as soon as the woman is pregnant you should stop the drug because even if the mechanism of action is not like TKIs, since the TKI proteins are more, the ATPase proteins are more common, while the myristoyl pockets are less common. Still, we don’t know that much about this drug, so we must be careful, but encouraging results are on the way.

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