Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• In relapsed/refractory AML, monotherapy with Olutasidenib resulted in an overall response of 41% (95% Confidence Interval (CI) 21-64), while combination therapy with Azacitidine led to a higher overall response of 46% (95% CI 27-67). Among treatment-naive AML patients, overall response rates were 25% (95% CI 1-81) with monotherapy and 77% (95% CI 46-95) with combination therapy.
• In relapsed/refractory gliomas with the IDH1R132X mutation, Olutasidenib monotherapy demonstrated a disease control rate of 48%, including an 8% partial response rate (2 patients) and 32% (8 patients) achieving stable disease for at least 4 months.
• AML and MDS: Common Grade 3-4 treatment-emergent adverse events for monotherapy included thrombocytopenia (28%), febrile neutropenia (22%), and anemia (22%). For combination therapy, thrombocytopenia (41%), febrile neutropenia (28%), neutropenia (28%), and anemia (20%) were reported. Mortality rates were 34% in monotherapy and 20% in combination therapy, primarily due to disease progression, with no deaths considered study-drug related.
• Relapsed/Refractory Gliomas: Common Grade 3-4 adverse events included increased alanine aminotransferase (12%) and increased aspartate aminotransferase (12%). No dose-limiting toxicities were observed.
• There is no population types or subgroups information available in the reviewed documents.