What is the efficacy of ivonib (ivitinib) combined with azacitidine?

Based on the results of the Phase 3AGILE clinical trial (NCT03173248), The FDA has approved the combination of ivonib and azacitidine as a new option for the treatment of patients with previously untreated IDH1mutated acute myeloid leukemia (AML). This combination therapy is particularly suitable for patients who are 75 years of age or older or who have comorbidities that are not suitable for invasive induction chemotherapy.

IDH1 gene mutations are present in approximately 6% to 10% of patients with acute myeloid leukemia. Ivonib, as a potent oral targeted inhibitor of mIDH1, has shown significant therapeutic effects. The AGILE study showed that avonib plus azacitidine had greater benefit than placebo plus azacitidine in newly diagnosed patients.

Preliminary study results show that the median survival time of patients who received the combination of ivonib and azacitidine reached 24 months, which was significantly better than the placebo group. At the same time, the event-free survival rate and complete response rate have also been significantly improved. In the ivonib plus azacitidine treatment group, the percentage of bone marrow blasts in patients decreased rapidly and remained at a low level for a long time.

In terms of safety, the incidence of adverse events was relatively lower in the avonib plus azacitidine group compared with the placebo plus azacitidine group. Although some degree of anemia and thrombocytopenia occurred in the combination group, overall the safety profile was acceptable. In addition, there were also differences in non-hematological adverse events between the two groups, but the incidence of adverse events such as nausea, vomiting, and diarrhea in the ivonib plus azacitidine group was relatively low.

In summary, the combination therapy of ivonib and azacitidine provides a new treatment option for patients with newly diagnosed IDH1 mutant acute myeloid leukemia and shows good efficacy and safety. The approval of this therapy will bring more treatment opportunities and hope to these patients.