Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial.

  title={Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial.},
  author={Justin Watts and Maria R. Baer and Jay Yang and Thomas Prebet and Sangmin Lee and Gary J Schiller and Shira Naomi Dinner and Arnaud Pigneux and Pau Montesinos and Eunice S. Wang and Karen Seiter and Andrew H. Wei and St{\'e}phane de Botton and Montserrat Arn{\'a}n and William B Donnellan and Anthony P. Schwarer and Christian R{\'e}cher and Brian A. Jonas and Paul Brent Ferrell and Christophe Marzac and Patrick F Kelly and Jennifer Sweeney and Sanjeev Forsyth and Sylvie Guichard and Julie A. Brevard and Patrick Henrick and Hesham Mohamed and Jordi Cort{\'e}s},
  journal={The Lancet. Haematology},
2 Citations



Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial

Olutasidenib 150 mg BID was well tolerated in patients with relapsed/refractory gliomas harboring an IDH1R132X mutation and demonstrated preliminary evidence of clinical activity in this heavily pretreated population.

Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia.

Inducing differentiation of myeloblasts, not cytotoxicity, seems to drive the clinical efficacy of enasidenib, a first-in-class, oral, selective inhibitor of mutant-IDH2 enzymes.

Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

  • C. DinardoA. Stein P. Vyas
  • Medicine, Biology
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2020
Ivosidenib plus azacitidine was well tolerated, with an expected safety profile consistent with monotherapy with each agent, and Responses were deep and durable, with most complete responders achieving mIDH1 mutation clearance.

A phase 1 study of IDH305 in patients with IDH1R132-mutant acute myeloid leukemia or myelodysplastic syndrome

The recommended dose for expansion/maximum tolerated dose of IDH305 in patients with IDH1R132-mutant acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) was identified and recommended phase 2 dose could not be declared.

Durable Remissions with Ivosidenib in IDH1‐Mutated Relapsed or Refractory AML

In patients with advanced IDH1‐mutated relapsed or refractory AML, ivosidenib at a dose of 500 mg daily was associated with a low frequency of grade 3 or higher treatment‐related adverse events and with transfusion independence, durable remissions, and molecular remissions in some patients with complete remission.

Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia.

Ivosidenib and azacitidine showed significant clinical benefit as compared with placebo and azACitidine in this difficult-to-treat population of patients with newly diagnosed IDH1-mutated acute myeloid leukemia.

Differentiation Syndrome with Ivosidenib and Enasidenib Treatment in Patients with Relapsed or Refractory IDH-Mutated AML: A U.S. Food and Drug Administration Systematic Analysis

Differentiation syndrome is a common and potentially fatal adverse reaction of IDH inhibitors, and use of standardized diagnostic criteria may aid in earlier diagnosis and treatment.

Differentiation Syndrome Associated With Enasidenib, a Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2: Analysis of a Phase 1/2 Study

Isocitrate dehydrogenase differentiation syndrome is a recognizable and potentially lethal clinical entity, occurring in approximately 12% of enasidenib-treated patients with mutant-IDH2 R/R AML, and requires prompt recognition and management.

FDA Approval Summary: Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation

The efficacy of ivosidenib was established on the basis of complete remission (CR) + CR with partial hematologic recovery (CRh) rate, duration of CR + CRh, and conversion from transfusion dependence to transfusion independence (TI) in Study AG120-C-001, a single-arm trial.

Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia.

In previously untreated patients with confirmed AML who were ineligible for intensive chemotherapy, overall survival was longer and the incidence of remission was higher among patients who received azacitidine plus venetoclax than among those who received zsitidine alone.