Servier is poised to go to market soon after the Phase III trial of its proposed drug for leukemia closed with positive results.
Servier is poised to go to market with a new indication after the Phase III trial of a trial of its leukemia drug in IDH1-mutated acute myeloid leukemia (AML) closed with positive results.
The global Agile trial ended with Tibsovo (ivosidenib tablets) in combination with azacitidine meeting both primary and key secondary endpoints in adults with previously untreated IDH1-mutated AML.
The double-blinded study tested the efficacy and safety of Tibsovo with azacitidine versus placebo and identified event-free survival (EFS) as the primary endpoint, defined based on the time from randomization until treatment failure, relapse from remission or death. Treatment failure meant the failure to achieve complete remission by the 24th week. The secondary endpoints were complete remission rate, or the percentage of participants who achieved a CR, overall survival, CR and complete remission with partial hematologic recovery (CRh) rate and objective response rate.
Data from the trial demonstrated that Tibsovo is the first IDH1 mutation-specific targeted treatment to show improved EFS (95% confidence interval) and OS (95% confidence interval). The median OS was 24 months for the Tibsovo plus azacitidine group, compared to only 7.9 months in the patients who received a placebo plus azacitidine. The CR rate was 47.2% in combination therapy versus just 14.9% in the placebo group.
“Patients with IDH1-mutated AML have a poor prognosis and have few, if any, treatment options, especially for newly diagnosed patients who are not eligible for intensive chemotherapy. The publication of the compelling Phase 3 AGILE study data in NEJM, reinforces the clinical importance of these results and supports Servier’s ongoing pursuit to serve patients with IDH1-mutated malignancies,” commented Susan Pandya, M.D., vice president for clinical development and head of the Cancer Metabolism Global Development Oncology & Immuno-Oncology arm at Servier.
AML is a type of blood and bone marrow cancer that logs around 20,000 new cases in the U.S. and 43,000 in Europe per year. The incidence increases with age, and the majority of patients eventually relapse and have a very poor prognosis, often no longer responding to chemotherapy. The five-year survival rate for the disease is around 29.5%, with IDH mutations observed in 6% to 10% of those diagnosed.
“Servier has placed oncology among its priorities and allocates more than 50% of its R&D budget to fighting cancer. This strategy initiated by the Group is now bringing results with new treatments and future indications for patients with hard-to-treat cancers,” added Claude Bertrand, the executive vice president for research and development at Servier, in the same press release.
Tibsovo is approved in the U.S. as a monotherapy for adults diagnosed with IDH1-mutant relapsed or refractory AML and adults who have been diagnosed with IDH1-mutant AML over 75 years old or with comorbidities that preclude intensive induction chemotherapy. Tibsovo is also the first and only therapy for patients with IDH1-mutated cholangiocarcinoma.
