TIBSOVO in Combination with Azacitidine Demonstrates Significant Efficacy in Previously Untreated IDH1-Mutated AML, According to Phase 3 AGILE Trial Data

Compared with placebo combined with azacitidine, TIBSOVO combined with azacitidine also demonstrated significant improvements in complete remission rate, complete remission, complete remission with partial hematological recovery, and objective response rate.

Safety profile remains favorable, consistent with previously published data.

Data from the Phase 3 AGILE trial in previously untreated IDH1-mutant acute myeloid leukemia patients will be presented on Monday, December 13, 2021, during the oral presentation session and will be featured in the official press program of the 63rd American Society of Hematology Annual Meeting.

Paris and Boston, December 13, 2021 /PRNewswire/ -- Servier, a growing leader in the field of oncology committed to bringing future promises to patients, announced today that Phase 3 data indicate that, compared with azacitidine combined with placebo, TIBSOVO is for adult patients with IDH1-mutated acute myeloid leukemia (AML) who are not suitable for high-intensity chemotherapy and have not been previously treated.^®(Ivosidenib tablets) combined with azacitidine chemotherapy significantly improved event-free survival (EFS) and overall survival (OS). These data from the global AGILE study will be presented on Monday, December 13, 2021 (Eastern Time 2:45 PM to 4:15 PM, Abstract #697) during an oral presentation session and will be featured in the official press program of the 63rd American Society of Hematology Annual Meeting and Exposition.

TIBSOVO in combination with azacitidine demonstrated EFS (Hazard Ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011).^1、2) showed statistically significant improvement. Additionally, TIBSOVO in combination with azacitidine demonstrated a statistically significant improvement in overall survival (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), with a median overall survival of 24.0 months in the ivosidenib plus azacitidine group compared to 7.9 months in the placebo plus azacitidine group.

Susan Pandya, MD, Vice President of Clinical Development at Servier Pharmaceuticals and Global Head of Oncology and Immuno-Oncology Cancer Metabolism, stated: "These significant findings from the TIBSOVO AGILE Phase 3 study reinforce our growing body of evidence supporting the concept of targeting IDH1 mutations early in hematologic cancers like acute myeloid leukemia. Up to 10% of AML patients have mutations in the IDH1 enzyme, and current treatment options are limited, especially for newly diagnosed patients who are not eligible for intensive chemotherapy."

Other StudiesResults
Researchers reported the key secondary endpoint results of the AGILE trial, including:

Patrick Therasse, MD, Vice President of Servier Group and Director of Late Stage and Lifecycle Management in the Oncology and Immuno-Oncology Therapeutic Area, stated: "We are very pleased to offer a new treatment option for previously untreated IDH1-mutated AML patients. This further provides significant clinical benefits for patients with acute myeloid leukemia and IDH1 mutations."

Stephane De Botton, M.D., Chief Investigator at the Gustave Roussy Institute in Villejuif, France, and Head of the Multidisciplinary Hematology Committee, stated: "Acute myeloid leukemia is a rapidly progressing cancer with often poor prognosis. Our treatment goal is to extend overall survival, and for these previously untreated IDH1-mutated acute myeloid leukemia patients, the impressive clinical benefits observed with TIBSOVO combined with azacitidine are highly promising."

Compared with placebo plus azacitidine, the common all-grade adverse events (AEs) occurring in more than 20% of patients treated with TIBSOVO plus azacitidine were as follows: nausea (42.3% vs 38.4%), vomiting (40.8% vs 26.0%), diarrhea (35.2% vs 35.6%), fever (33.8% vs 39.7%), anemia (31.0% vs 28.8%), febrile neutropenia (28.2% vs 34.2%), thrombocytopenia (28.2% vs 20.5%), neutropenia (28.2% vs 16.4%), constipation (26.8% vs 52.1%), and pneumonia (23.9% vs 31.5%).

Due to the compelling efficacy data of TIBSOVO, the AGILE study has ceased further participant recruitment.

Servier is in discussions with health regulatory authorities to submit materials for the expansion of the currently approved TIBSOVO indications.

TIBSOVO[*] is currently approved in the United States as a monotherapy for adult patients with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML), and for newly diagnosed adult patients aged 75 years or older with IDH1-mutated AML or those with comorbidities who are ineligible for intensive induction chemotherapy. Recently, TIBSOVO was approved as the first and only targeted treatment for patients with previously treated IDH1-mutated cholangiocarcinoma.