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Olutasidenib in patients with AML following venetoclax exposure: Final 5-year results from a phase II trial
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Final 5-year results from a phase II trial (NCT02719574) evaluating the efficacy and safety of olutasidenib in a subgroup of patients with IDH1mut AML following exposure to venetoclax were presented by Jorge Cortes at the SOHO 2024 Annual Meeting.1 A total of 18 adult patients, with median age of 74 years, were included. Patients received olutasidenib 150 mg alone (n = 16) or in combination with standard of care (n = 2). The median duration of prior venetoclax treatment was 5.4 months.1 |
| Key learnings |
| Olutasidenib resulted in ORR/CRc in 50% of all patients previously exposed to venetoclax, including CR/CRh in 39% and CRi in 11% of patients. |
| Of the 18 patients, 16 were R/R to venetoclax. Among these patients, treatment with olutasidenib resulted in ORR/CRc, CR/CRh, and CRi in 44%, 31%, and 13%, respectively. Median time to achieve CR/CRh was 2.1 months and the estimated duration of CR/CRh response was ≥18 months in 80% of patients. |
| In the pivotal cohort of 12 patients with R/R AML post venetoclax, olutasidenib was associated with an ORR/CRc of 50%, CR/CRh of 33%, and CRi of 17%. The median time to achieve CR/CRh was 2.4 months and the estimated duration of CR/CRh response was ≥18 months in 75% of patients. |
| Two patients with CRi with prior venetoclax received maintenance treatment with olutasidenib. Both patients showed improved CR, with a CR duration of 15.7 months and >31.3 months (ongoing), respectively. |
| All patients experienced ≥1 AE, with 89% reporting Grade 3−5 AEs. The most common Grade 3 and 4 AEs were anemia (33%) and neutropenia (22%), respectively. |
| The results suggested that olutasidenib led to deep and durable remissions in patients with IDH1mut AML who were R/R to a prior venetoclax regimen. In those achieving CRi with venetoclax, maintenance with olutasidenib resulted in improved CR. However, the study was limited by its small sample size. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CR, complete remission; CRc, composite CR (CR+CRh+CRi); CRh, CR with partial hematologic recovery; CRi, CR with incomplete hematologic recovery; IDH1mut, IDH1 mutated; ORR, overall response rate; R/R, relapsed/refractory; SOHO, Society of Hematologic Oncology.
- Cortes J. Response to olutasidenib in patients with acute myeloid leukemia (AML) following venetoclax failure. Poster# AML-532. Presented at: Society of Hematologic Oncology 2024 Annual Meeting; Sep 4–7, 2024; Houston, US.
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