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Association details:
| Biomarker: | IDH1 R132 |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Rezlidhia (olutasidenib) (IDH1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
Excerpt:
...- Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site...
Trial ID:
Source:
Title:
2757 Olutasidenib (FT-2102) Induces Durable Complete Remissions in Patients with Relapsed/Refractory mIDH1 Acute Myeloid Leukemia. Results from a Planned Interim Analysis of a Phase 2 Pivotal Clinical Trial
Published date:
11/03/2022
Excerpt:
The CR+CRh rate was 35% (n=51; 95% CI, 27.0-43.0); median time to CR/CRh was 1.9 months (0.9-5.6). The ORR was 48% (n=71; 95% CI, 40.0-56.7). Response rates were similar for 12 pts who had received prior venetoclax. Median duration of CR/CRh was 25.9 months (95% CI, 10.6-NE), with 28 (55%) pts censored, all of whom were on treatment at data cut-off. Median DOR was 11.7 months (95% CI, 6.9-25.9). Median OS was 11.6 months (95% CI, 8.9-15.5)...Olutasidenib induced durable remissions with a well-characterized and manageable side-effect profile. Transfusion independence was achieved across all response groups. The observed activity is clinically meaningful and represents a therapeutic advance in the treatment of this molecularly defined, poor-prognosis patient population with R/R AML, including those with prior venetoclax failure.
DOI:
https://doi.org/10.1182/blood-2022-167330
Trial ID:
