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.
By Reuters Staff
Posted on
Previous Article
« ACS patients with several metabolic risk factors may benefit most from PCSK9 inhibitors Next Article
Support for risk-adapted androgen deprivation plus high-dose radiotherapy in prostate cancer »
« ACS patients with several metabolic risk factors may benefit most from PCSK9 inhibitors Next Article
Support for risk-adapted androgen deprivation plus high-dose radiotherapy in prostate cancer »
Related Articles
February 20, 2023
Promising results for triplet therapy with magrolimab in AML
February 18, 2021
More complicated course of COVID-19 in leukaemia patients
September 9, 2020
Magrolimab plus azacitidine: good ORR in MDS/AML
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy