Adding Ivosidenib to Azacitidine Improves Survival in IDH1-Mutated AML

By Reuters Staff

April 21, 2022

NEW YORK (Reuters Health) - Survival was more than twice as long when the Servier drug ivosidenib was added to azacitidine in 146 patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML), according to results of the phase-3 AGILE trial.

After a median follow-up of 12.4 months, event-free survival was 36% in the ivosidenib-azacitidine group versus 16% in the placebo-azacitidine group (hazard ratio, 0.33; P=0.002).

A complete remission was seen in 47% of ivosidenib patients and 15% with placebo, according to Dr. Pau Montesinos of Hospital Universitari i Politecnic La Fe, in Valencia, Spain, and colleagues.

Median overall survival was 24.0 months with the two-drug combination compared with 7.9 months in the placebo group (P=0.001), the researchers report in the New England Journal of Medicine.

Rates of neutropenia and bleeding were higher with ivosidenib, but the incidences of infection and febrile neutropenia were lower.

The company announced March 7 that its supplemental new drug application had been granted a priority review from the U.S. Food and Drug Administration, based on the AGILE results, which were released in December.

The drug, which goes by the brand name Tibsovo, has already been approved for cholangiocarcinoma and as a monotherapy for adults with IDH1-mutant relapsed or refractory AML.

Agios Pharmaceuticals and Servier Pharmaceuticals paid for the trial.

SOURCE: https://bit.ly/3jRNGkC The New England Journal of Medicine, online April 20, 2022.

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