Two-Year Updated Results of Asciminib Managed-Access Program (MAP) in Russia

Turkina, Anna; Kuzmina, Elena; Lomaia, Elza; Morozova, Elena; Shukhov, Oleg; Petrová, Anna; Chitanava, Tamara; Vlasova, Julia J.; Chelysheva, Ekaterina; Sbityakova, Evgeniya; Nemchenko, Irina; Bykova, Anastasiya; Gurianova, Margarita; Кохно, А. В.; Паровичникова, Е Н

doi:10.1182/blood-2022-162268

Cited by 2 publications

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“…Asciminib, the first BCR::ABL inhibitor targeting the myristoyl pocket rather than the ATP-binding site of the ABL kinase domain, was approved by the European Commission on 25 August 2022, for the treatment of patients with CP-CML after failure on two or more TKIs [ 47 , 48 , 49 ] (with approval not yet sought for patients with the T315I mutation). The efficacy and tolerability of asciminib in patients with CML-CP with multi-TKI failure have also been demonstrated in real-world studies conducted in various countries, where it has been available for compassionate use since 2016 [ 50 , 51 , 52 , 53 , 54 ].…”

Section: Discussionmentioning

confidence: 99%

A Multicenter Retrospective Chart Review Study of Treatment and Disease Patterns and Clinical Outcomes of Patients with Chronic-Phase Chronic Myeloid Leukemia in Third-Line Treatment or with T315I Mutation

Nicolini,

Huguet,

Huynh

et al. 2023

Cancers

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This retrospective chart review study investigated the clinical burden of adult patients with chronic-phase chronic myeloid leukemia (CP-CML) treated at three centers in France (2006–2021) who failed on two or more tyrosine kinase inhibitors (TKIs; third-line [3L]+ cohort) or harbored the BCR::ABL1 T315I mutation (T315I cohort). In the 3L+ cohort (N = 157; median age at diagnosis, 56 years), TKIs received in 3L (median duration: 17 months) were dasatinib (32%), nilotinib (19%), imatinib (18%), ponatinib (17%), and bosutinib (14%). Of the 145 patients with documented responses in 3L, 42% experienced major molecular response (MMR) at 12 months. Median event-free survival [95% confidence interval] was 53.6 [44.0, 67.5] months, and median progression-free survival and overall survival (OS) were not reached. Achieving MMR in 3L was associated with a decreased mortality risk. In the T315I cohort (N = 17; 52 years), 41% of patients received five or more lines of therapy. Following identification of the T315I mutation, ponatinib was the most common TKI used (59%); the median [interquartile range] OS was 5 [3–10] years. The most common adverse events were infections (3L+ cohort) and thrombocytopenia (T315I cohort) (both 18%). Well-tolerated therapies that achieve durable responses are needed in 3L or earlier to improve CP-CML prognosis.

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Section: Discussionmentioning

confidence: 99%

A Multicenter Retrospective Chart Review Study of Treatment and Disease Patterns and Clinical Outcomes of Patients with Chronic-Phase Chronic Myeloid Leukemia in Third-Line Treatment or with T315I Mutation

Nicolini,

Huguet,

Huynh

et al. 2023

Cancers

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“…терапии составила 45, 48 и 45 % соответственно. Вероятность достижения БМО была значимо выше у пациентов, которым ранее не проводилась терапия понатинибом (75 vs 23 % у пациентов, ранее получавших понатиниб; p = 0,006) [46]. У 22 (44 %) больных наблюдались НЯ любой степени тяжести.…”

Section: лечение резистентного хмлunclassified

Результаты Применения Асциминиба, Первого Аллостерического Ингибитора BCR::ABL1-тирозинкиназы, У Больных Хроническим Миелолейкозом Со Множественной Резистентностью К Предшествующей Терапии

Туркина,

Кузьмина

2024

Clinical Oncohematology

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Currently, there is a crucial need for new treatment approaches to overcome the resistance and intolerance of several tyrosine kinase inhibitor (TKI) therapy lines in chronic myeloid leukemia (CML) patients. Asciminib, the first in its class BCR::ABL1-tyrosine kinase inhibitor specifically targeting ABL myristoyl pocket (STAMP), demonstrated efficacy and safety in CML patients with prior TKI therapy failure, including the cases with pan-resistant T315I mutation in the chimeric BCR::ABL1 gene. The present review focuses on the asciminib mechanism of action, the results of both preclinical and clinical phase I and III studies. Due to the favorable cardiovascular toxicity profile of asciminib, the scope of its application can be extended to patients with cardiovascular co-morbidities. Asciminib is registered in the Russian Federation in January 2023, so treatment algorithms for CML patients with ineffectiveness or intolerance of prior therapy should be updated in line with this new option.

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Two-Year Updated Results of Asciminib Managed-Access Program (MAP) in Russia

Cited by 2 publications

References 0 publications

A Multicenter Retrospective Chart Review Study of Treatment and Disease Patterns and Clinical Outcomes of Patients with Chronic-Phase Chronic Myeloid Leukemia in Third-Line Treatment or with T315I Mutation

A Multicenter Retrospective Chart Review Study of Treatment and Disease Patterns and Clinical Outcomes of Patients with Chronic-Phase Chronic Myeloid Leukemia in Third-Line Treatment or with T315I Mutation

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