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Ivosidenib

(Tibsovo®)

Tibsovo®

Drug updated on 10/29/2024

Dosage FormTablet (oral; 250 mg)
Drug ClassIsocitrate dehydrogenase-1 (IDH1) inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, and with a susceptible IDH1 mutation as detected by an FDA-approved test
  • Indicated for the treatment of adult patients with relapsed or refractory AML and with a susceptible IDH1 mutation as detected by an FDA-approved test
  • Indicated for for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) and with a susceptible IDH1 mutation as detected by an FDA-approved test
  • Indicated for for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated and with a susceptible IDH1 mutation as detected by an FDA-approved test.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Newly Diagnosed IDH-Mutated AML: In patients with newly diagnosed IDH-mutated acute myeloid leukemia (AML), the complete response (CR) rate was 47%, the overall response rate (ORR) was 65%, the 2-year overall survival (OS) rate was 45%, and the 2-year event-free survival (EFS) rate was 29%.
  • Relapsed or Refractory IDH-Mutated AML: For relapsed or refractory IDH-mutated AML, the CR rate was 21%, the ORR was 40%, the 2-year OS rate was 15%, the median OS was 8.21 months, and the median EFS was 4.73 months, indicating reduced effectiveness compared to newly diagnosed patients.
  • Combination with Hypomethylating Agents: In patients ineligible for first-line induction chemotherapy, the addition of ivosidenib (Tibsovo) to hypomethylating agents (HMAs) resulted in improved overall survival hazard ratios (HRs) of 0.44-0.66 and event-free survival HRs of 0.33-0.63, suggesting enhanced efficacy in this difficult-to-treat population.
  • Adverse Events in IDH-Mutated AML Treatments: Gastrointestinal adverse events were the most frequently occurring all-grade adverse events, while hematologic adverse events were the most common events at ≥ grade 3. Differentiation syndrome was also noted as a significant adverse event requiring management.
  • Safety of Combination Therapies: In patients receiving combination therapies, adverse events were more frequent compared to control arms, except for the combination of ivosidenib and azacitidine, which did not show an increase in adverse events, suggesting a more favorable safety profile for this specific combination.
  • Population Types and Subgroup Considerations: In newly diagnosed IDH-mutated acute myeloid leukemia (AML), the complete response (CR) rate was 47% and the overall response rate (ORR) was 65%, with a 2-year overall survival (OS) rate of 45% and a 2-year event-free survival (EFS) rate of 29%. In contrast, patients with relapsed or refractory IDH-mutated AML had lower CR and ORR rates at 21% and 40%, respectively, with a 2-year OS rate of 15%, median OS of 8.21 months, and median EFS of 4.73 months. Additionally, in AML patients ineligible for first-line induction chemotherapy, the combination of ivosidenib with hypomethylating agents (HMAs) demonstrated improved OS and EFS hazard ratios (HRs) ranging from 0.44 to 0.66 for OS and from 0.33 to 0.63 for EFS.