Real-world data on the use of asciminib in chronic-phase chronic myeloid leukemia after two or more prior tyrosine kinase inhibitors: Results of the Turkish managed access program along with a literature review.
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Özmen Deniz, Kürekçi Derya Deniz, Özkocaman Vildan, Altındağ Avcı Burcu, Bozer Denis Sabriye, Kasar Mutlu, Şahin Osman, Korkmaz Gülten, Can Ferda, Pepeler Mehmet Sezgin, Erkut Nergiz, Kırkızlar Onur, Yel Uygun Kübra, Bulduk Tuba, Yıldırım Murat, Aslaner Müzeyyen, Altındal Şermin, Arikan Fatma, Dal Mehmet Sinan, Deveci Burak, Güler Nil, Güneş Ahmet Kürşad, Gürkan Emel, Özbalcı Demircan, Öztürk Osman Can, Ülküden Burcu, Yılmaz Hüseyin, Yüksel Meltem Kurt, Aylı Meltem, Demir Ahmet Muzaffer, Özatlı Düzgün, Özkalemkaş Fahir, Saydam Güray, Sönmez Mehmet, Turgut Burhan, Turgut Mehmet, Ünal Ali, Eşkazan Ahmet Emre
Аннотация
METHODS: This multicenter, retrospective study included patients with CML-CP from 25 centers in Turkey who received asciminib through a Managed Access Program. All patients had received at least two prior tyrosine kinase inhibitors (TKIs) or harbored the T315I mutation. Early molecular response (EMR), major molecular response (MMR), and deep molecular response (DMR) were evaluated according to the ELN 2020 criteria.
RESULTS: There were 49 patients with a median age of 61 years. Patients had a median of 4 prior TKIs, and resistance was the most common reason for switching (47%). Seven patients (14.2%) carried the T315I mutation. EMR at 3 months was achieved in 80% of evaluable patients, higher among those switched due to intolerance than to resistance (90% vs. 74%), and higher among ponatinib-pretreated than ponatinib-naïve patients (94% vs. 72%). Cumulative MMR and DMR rates were 32.6% and 37.2%, respectively. Higher response rates were observed in patients switched due to toxicities and in those previously treated with ponatinib. Among patients with the T315I mutation, 71.4% maintained or improved their response. Three patients died during follow-up. Asciminib 40 mg BID and 80 mg QD regimens seemed to be comparable regarding both efficacy and safety.
CONCLUSION: In this real-world cohort, asciminib was well tolerated and provided meaningful responses in heavily pretreated CML-CP patients, consistent with the published data. Favorable outcomes in ponatinib-pretreated patients may partly reflect prior achievement of optimal response before switching due to limited access.