Portal de investigación
Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML.
Fecha de publicación:
Fecha Ahead of Print:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- de Botton, Stephane
- Fenaux, Pierre
- Yee KWL
- Recher, Christian
- Wei, Andrew H
- Taussig, David C
- Pigneux, Arnaud
- Braun, Thorsten
- Curti, Antonio
- Grove, Carolyn
- Jonas, Brian A
- Khwaja, Asim
- Legrand, Ollivier
- Peterlin, Pierre
- Arnan, Montserrat
- Blum, William
- Cilloni, Daniela
- Hiwase, Devendra K
- Jurcic, Joseph G
- Krauter, Jurgen
- Thomas, Xavier
- Watts, Justin M
- Yang, Jay
- Polyanskaya, Olga
- Brevard, Julie
- Sweeney, Jennifer
- Barrett, Emma
- Cortes, Jorge
Grupos
Abstract
Olutasidenib (FT-2102) is a potent, selective, oral, small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1). Overall, 153 IDH-1 inhibitor naïve patients with mIDH1R132 relapsed/refractory (R/R) acute myeloid leukemia (AML) received olutasidenib monotherapy 150 mg twice daily in the pivotal cohort of this study. Median age (range) was 71 years (32-87) and the median number of prior regimens was 2 (1-7). The rate of complete remission (CR) plus complete remission with partial hematologic recovery (CRh) was 35% (n=51; 95% CI, 27.0-43.0) and the overall response rate was 48% (n=71; 95% CI, 40.0-56.7). Response rates were similar in patients who had and who had not received prior venetoclax. With 55% of patients censored at the time of data cut-off, median duration of CR/CRh was 25.9 months (95% CI, 13.5-NE). Median duration of overall response was 11.7 months (95% CI, 6.9-25.9). Median overall survival was 11.6 months (95% CI, 8.9-15.5). Of 86 patients who were transfusion-dependent at baseline, a 56-day transfusion independence was achieved in 29 (34%), including patients in all response groups. Grade 3/4 treatment-emergent adverse events (=10%) were febrile neutropenia and anemia (n=31; 20% each), thrombocytopenia (n=25; 16%), and neutropenia (n=20; 13%). Differentiation syndrome adverse events of special interest occurred in 22 (14%) patients, with 14 (9%) grade =3 and 1 fatal case reported. Overall, olutasidenib induced durable remissions and transfusion independence with a well-characterized and manageable side-effect profile. The observed efficacy represents a therapeutic advance in this molecularly defined, poor-prognosis patient population with mIDH1 R/R AML. This trial is registered at www.clinicaltrials.gov as NCT02719574.
Copyright © 2023 American Society of Hematology.
Datos de la publicación
- ISSN/ISSNe:
- 2473-9529, 2473-9537
- Tipo:
- Article
- Páginas:
- 3117-3127
- PubMed:
- 36724515
- Enlace a otro recurso:
- www.scopus.com
- Factor de Impacto:
- 2,795 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
Blood Advances ELSEVIER
Citas Recibidas en Web of Science: 108
Citas Recibidas en Scopus: 101
Documentos
- No hay documentos
Filiaciones
Keywords
- MUTATIONS; LEUKEMIA