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Real-life analysis on safety and efficacy of asciminib for ponatinib pretreated patients with chronic myeloid leukemia

2022; Springer Science+Business Media; Volume: 101; Issue: 10 Linguagem: Inglês

10.1007/s00277-022-04932-6

1432-0584

Alejandro Luna, Lucía Pérez‐Lamas, Concepción Boqué, Pilar Giraldo, Blanca Xicoy, Concepción Ruiz Nuño, Melania Moreno Vega, Alberto Álvarez‐Larrán, A. Salamanca, Ana GARCIA-NOBLEJAS, Ferran Vall‐Llovera, Lucı́a Villalón, Natalia de las Heras, Elena Rámila, Manuel Pérez‐Encinas, Beatriz Cuevas, R. Perez-Lopez, Fermín Sánchez‐Guijo, Antonio Jiménez‐Velasco, Sunil Lakhwani, Luis Felipe Casado, Anna Rosell, A. Escola, María José Fernández, Claudia García-Hernández, Carlos Cerveró, Elvira Mora, Miguel Sagüés, Sara Suárez-Varela, Paula Saibene Vélez, Patricia Carrascosa Mastell, Rocio Fe Bitaube, L Serrano, M. Cortés, Juan Antonio Vera Goñi, Juan Luis Steegmann, Valle Gomez Garcia de Soria, Juan Manuel Alonso‐Domínguez, Mercedes Colorado Araujo, Antonio Paz Coll, Juan Carlos Hernández‐Boluda, Valentín García‐Gutiérrez,

Myeloproliferative Neoplasms: Diagnosis and Treatment

Failure of second-generation tyrosine kinase inhibitors (2GTKI) is a challenging situation in patients with chronic myeloid leukemia (CML). Asciminib, recently approved by the US Federal Drug Administration, has demonstrated in clinical trials a good efficacy and safety profile after failure of 2GTKI. However, no study has specifically addressed response rates to asciminib in ponatinib pretreated patients (PPT). Here, we present data on responses to asciminib from 52 patients in clinical practice, 20 of them (38%) with prior ponatinib exposure. We analyzed retrospectively responses and toxicities under asciminib and compared results between PPT and non-PPT patients.After a median follow-up of 30 months, 34 patients (65%) switched to asciminib due to intolerance and 18 (35%) due to resistance to prior TKIs. Forty-six patients (88%) had received at least 3 prior TKIs. Regarding responses, complete cytogenetic response was achieved or maintained in 74% and 53% for non-PPT and PPT patients, respectively. Deeper responses such as major molecular response and molecular response 4.5 were achieved in 65% and 19% in non-PPT versus 32% and 11% in PPT, respectively. Two patients (4%) harbored the T315I mutation, both PPT.In terms of toxicities, non-PPT displayed 22% grade 3-4 TEAE versus 20% in PPT. Four patients (20% of PPT) suffered from cross-intolerance with asciminib as they did under ponatinib.Our data supports asciminib as a promising alternative in resistant and intolerant non-PPT patients, as well as in intolerant PPT patients; the resistant PPT subset remains as a challenging group in need of further therapeutic options.