Summary

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• Rezlidhia (olutasidenib) is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
• This summary is based on the review of one randomized controlled trial(s). ^[1]
• In patients with relapsed or refractory acute myeloid leukemia (AML), monotherapy with the drug achieved an overall response rate of 41% (95% CI 21-64), while combination therapy with Azacitidine showed a slightly higher response rate of 46% (95% CI 27-67).
• For treatment-naive AML patients, the overall response rate was 25% (95% CI 1-81) with monotherapy, significantly increasing to 77% (95% CI 46-95) when used in combination with Azacitidine.
• Common Grade 3-4 Treatment-Emergent Adverse Events (TEAEs): Monotherapy in AML patients resulted in thrombocytopenia (28%, 9/32), febrile neutropenia (22%, 7/32), and anemia (22%, 7/32). Combination therapy led to higher incidences of thrombocytopenia (41%, 19/46), febrile neutropenia (28%, 13/46), neutropenia (28%, 13/46), and anemia (20%, 9/46).
• Mortality: The mortality rate was 34% (11/32) in the monotherapy group and 20% (9/46) in the combination therapy group. The most common cause of death in both groups was disease progression (9%). No deaths were considered study-drug related.
• The study focused on patients aged 18 years or older with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) harboring mutant IDH1, with an Eastern Cooperative Oncology Group performance status of 0-2. Key findings for these groups include a higher overall response rate in treatment-naive AML patients with combination therapy (77%) compared to monotherapy (25%), and a safety profile indicating a higher incidence of grade 3-4 treatment-emergent adverse events, particularly in the combination therapy group. Mortality was higher in the monotherapy group (34%) compared to the combination therapy group (20%).