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Paris and Boston, December 11, 2021 / CNW/ – Servier, a growing oncology leader dedicated to bringing hope to the patients we serve, today announced Phase 3 data, proving TIBSOVO® Compared with azacitidine plus placebo, in adult patients with IDH1 mutant acute myeloid leukemia (AML) who have not previously been treated, azacitidine plus placebo is significantly more effective than azacitidine plus placebo. This improved event-free survival (EFS) and overall survival (OS). Chemotherapy.These data from the global AGILE research will be presented at the oral meeting Monday, December 13, 2021 from 2:45-4:15pm EST, Abstract #697, and appeared in the official news program during the 63rd American Society of Hematology Annual Meeting and Expo.
TIBSOVO combined with azacitidine showed a statistically significant improvement in EFS (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, P = 0.0011 on one side 1,2). In addition, the combination of TIBSOVO and azacitidine showed a statistically significant improvement in OS (HR = 0.44 [95% CI 0.27, 0.73]; Unilateral P = 0.0005), the median OS of the ivosidenib + azacitidine group was 24.0 months, and the median OS of the placebo + azacitidine group was 7.9 months.
“These important findings of TIBSOVO’s AGILE Phase 3 study support our growing evidence and support the rationale for targeting IDH1 mutations in early blood cancers such as acute myeloid leukemia,” said Susan Pandia, MD, Servier Pharmaceuticals Vice President of Clinical Development and Head of Cancer Metabolism Global Development Oncology and Immuno-oncology. “As many as 10% of AML patients have IDH1 enzyme mutations, and current treatment options are limited, especially for those newly diagnosed patients who are not eligible for intensive chemotherapy.”
Other research findings
The researchers reported the results of the key secondary endpoints of the AGILE trial, including:
- The complete remission (CR) rate of TIBSOVO combined with azacitidine was 47.2% (n=34/72), while the placebo plus azacitidine was 14.9% (n=11/74) (p <0.0001).
- The CR + complete remission and partial hematological recovery rate (CR + CRh rate) of TIBSOVO combined with azacitidine was 52.8% (n=38/72), while the placebo plus azacitidine was 17.6% (n=13/ 74) (p <0.0001).
- The objective response rate (ORR) of TIBSOVO combined with azacitidine was 62.5% (n=45/72), while the placebo plus azacitidine was 18.9% (n=14/74) (p <0.0001).
“We are very pleased that it is possible to bring new treatment options to previously untreated IDH1 mutant AML patients. This further expands the significant clinical benefits of acute myeloid leukemia and IDH1 mutation patients,” said Patrick Serrase, MD, Ph.D., Vice President of Servier Group, head of late and life cycle management in the field of oncology and immuno-oncology treatments.
Acute myeloid leukemia is a rapidly progressing cancer, and the prognosis is often poor.” Stephen De Botton, MD Ph.D., Principal Investigator and Head of the Multidisciplinary Hematology Committee of the Gustave Roussy Institute in Villejuif, France“Our treatment goal is to prolong overall survival. The impressive clinical benefits of TIBSOVO combined with azacitidine are very promising for these previously untreated patients with IDH1 mutant acute myeloid leukemia.”
In patients receiving TIBSOVO combined with azacitidine and placebo plus azacitidine, more than 20% of the common full-grade adverse events (AE) were nausea (42.3% vs. 38.4%) and 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%), 2.46%)%), constipation (26.8% vs. 52.1%), and pneumonia (23.9% vs. 31.5%).
Due to convincing TIBSOVO efficacy data, the AGILE study has stopped further recruitment.
Servier is discussing submissions with regulatory health authorities to expand TIBSOVO’s currently approved indications.
Tibsovo[*] It is currently approved in the United States as a monotherapy for IDH1 mutant relapsed or refractory acute myeloid leukemia (AML) adults, and newly diagnosed IDH1 mutant AML adults ≥75 years of age or adults with comorbidities using intensive induction chemotherapy. Recently, TIBSOVO was approved as the first and only targeted therapy for previously treated patients with IDH1 mutant cholangiocarcinoma.
About NCT03173248 AGILE Phase 3 AML Trial
The AGILE trial is a global phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial that aims to evaluate the efficacy and efficacy of TIBSOVO combined with azacitidine and placebo combined with azacitidine in previously untreated adults with IDH1 Safety-Mutant acute myeloid leukemia (AML) not suitable for intensive chemotherapy (≥75 years of age or with comorbidities for which intensive induction chemotherapy cannot be used). The primary endpoint of the study is EFS, which is defined as the time from randomization to treatment failure, remission of relapse, or death from any cause, whichever occurs first. Treatment failure was defined as failure to achieve complete remission (CR) by week 24.
Other key secondary endpoints include complete remission rate (CR rate), defined as the proportion of participants who reach CR; overall survival (OS), defined as the time from the date of randomization to the date of death from any cause; CR and complete remission, partial Hematology recovery (CRh) rate, defined as…
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