On August 2, 2021 Servier, a global pharmaceutical company, reported the global Phase 3 double blinded placebo controlled AGILE study of TIBSOVO (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) met its primary endpoint of event-free survival (EFS)1,2 (Press release, Servier, AUG 2, 2021, View Source [SID1234585561]). Treatment with TIBSOVO in combination with azacitidine compared to azacitidine in combination with placebo demonstrated a statistically significant improvement in EFS. Additionally, the trial met all of its key secondary endpoints, including complete remission rate (CR rate), overall survival (OS), CR and complete remission with partial hematologic recovery rate (CRh rate) and objective response rate (ORR). The safety profile of TIBSOVO in combination with azacitidine was consistent with previously published data. The study recently halted further enrollment based on the recommendation of the Independent Data Monitoring Committee (IDMC), as a difference of clinical importance was noted between the treatment groups.
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"The results of AGILE represent a major breakthrough and will be welcome news for patients dealing with previously untreated IDH1-mutated acute myeloid leukemia," said Claude Bertrand, Executive Vice President, R&D, Servier Group. "We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world."
A full analysis of the AGILE trial will be submitted for a presentation at a future medical congress.
"Acute myeloid leukemia has a poor prognosis, especially for newly diagnosed patients who are not eligible for intensive chemotherapy," said Susan Pandya, M.D., Vice President Clinical Development, Servier Pharmaceuticals. "TIBSOVO monotherapy has been instrumental in transforming outcomes for adult patients with newly diagnosed or relapsed refractory AML harboring an IDH1 mutation. These promising results from the AGILE study support the added benefit of inhibiting the mutant IDH1 enzyme in combination with standard chemotherapy in the newly diagnosed intensive chemotherapy ineligible setting. We look forward to presenting the full results of the AGILE trial to show how TIBSOVO in combination with azacitidine may improve outcomes in previously untreated patients with IDH1-mutated acute myeloid leukemia."
TIBSOVO* is currently approved in the U.S. as monotherapy for the treatment of adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML), and for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. Recently, the U.S. Food and Drug Administration (FDA) accepted Servier’s supplemental New Drug Application (sNDA) for TIBSOVO as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma. The sNDA was granted Priority Review by the FDA.
About AGILE Phase 3 Trial
The AGILE trial is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO in combination with azacitidine compared to placebo in combination with azacitidine, in newly diagnosed AML patients non eligible for intensive chemotherapy. The study’s primary endpoint is event-free survival (EFS), defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure is defined as failure to achieve complete remission (CR) by Week 24.
Other key secondary endpoints included complete remission rate (CR rate), defined as the proportion of participants who achieve a CR; overall survival (OS), defined as the time from date of randomization to the date of death due to any cause; CR and complete remission with partial hematologic recovery (CRh) rate, defined as the proportion of participants who achieve a CR or CRh; and objective response rate (ORR), defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]), partial remission (PR), and morphologic leukemia-free state (MLFS).
About Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases in the U.S., and 43,000 cases in Europe each year3,4. The majority of patients with AML eventually relapse. Relapsed or refractory AML has a poor prognosis5. The five-year survival rate is approximately 27%3. For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia6.