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Molecular Profile IDH1 R132C
Therapy Azacitidine + Ivosidenib
Indication/Tumor Type acute myeloid leukemia
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
IDH1 R132C acute myeloid leukemia sensitive Azacitidine + Ivosidenib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (AGILE) that supported FDA approval, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination therapy significantly improved event-free survival (HR 0.33, p=0.002) and median overall survival (24.0 vs 7.9 mo, HR 0.44, p=0.001) compared to Vidaza (azacitidine) plus placebo in patients with newly diagnosed acute myeloid leukemia harboring IDH1 mutations including R132C/H/G/L/S (PMID: 35443108; NCT03173248). 35443108 detail... detail...
IDH1 R132C acute myeloid leukemia sensitive Azacitidine + Ivosidenib Phase Ib/II Actionable In a Phase Ib trial, Tibsovo (ivosidenib) and Vidaza (azacitidine) combination treatment demonstrated a favorable safety profile and resulted in an objective response rate (ORR) of 78.3% (18/23, 14 complete remission) and a 12-month overall survival probability of 82% in patients with newly diagnosed acute myeloid leukemia harboring IDH1 R132C (n=14), R132H (n=4), or R132L (n=3) mutations (PMID: 33119479; NCT02677922). 33119479
PubMed Id Reference Title Details
Full reference...
Tibsovo (ivosidenib) FDA Drug Label Full reference...
(33119479) Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia. Full reference...
(35443108) Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. Full reference...