Combination of Tibsovo-Azacitidine Improves Overall Survival Against Acute Myeloid Leukemia
TIBSOVO in combination with azacitidine compared to placebo plus azacitidine also demonstrated significant improvements in complete remission rate, complete remission and complete remission with partial hematologic recovery rate and objective response rate
Safety profile was favorable and consistent with previously published data
Data from the Phase 3 AGILE trial of patients with previously untreated IDH1-mutated acute myeloid leukemia will be presented in an oral session on Monday, December 13, 2021, and featured in the official press program of the 63rd American Society of Hematology Annual Meeting
PARIS and BOSTON, Dec. 13, 2021 /PRNewswire/ — Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced Phase 3 data demonstrating that TIBSOVO® (ivosidenib tablets) in combination with the chemotherapy azacitidine significantly improved event-free survival (EFS) and overall survival (OS) compared to azacitidine plus placebo in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy. These data from the global AGILE study will be presented in an oral session on Monday, December 13, 2021 from 2:45 – 4:15 PM ET, Abstract #697 and featured in the official press program during the 63rd American Society of Hematology Annual Meeting and Exposition.
Treatment with TIBSOVO in combination with azacitidine demonstrated a statistically significant improvement in EFS (hazard ratio [HR] = 0.33, 95% CI 0.16, 0.69, 1-sided P = 0.0011 1,2). In addition, the combination of TIBSOVO with azacitidine showed a statistically significant improvement in OS (HR = 0.44 [95% CI 0.27, 0.73]; 1-sided P = 0.0005), with a median OS of 24.0 months in the ivosidenib + azacitidine arm vs 7.9 months in the placebo + azacitidine arm.
“These significant findings from the AGILE Phase 3 study for TIBSOVO bolster our growing body of evidence supporting the rationale to target IDH1 mutations early in blood cancers like acute myeloid leukemia,” said Susan Pandya, M.D., Vice President Clinical Development & Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier Pharmaceuticals. “Up to 10 percent of patients with AML have mutations in the IDH1 enzyme, and current treatment options are limited, especially for those who are newly diagnosed and are not eligible for intensive chemotherapy.”
Additional Study Results
Investigators reported on results of key secondary endpoints of the AGILE trial including:
- Complete remission (CR) rate was 47.2% (n=34/72) for TIBSOVO in combination with azacitidine vs. 14.9% (n=11/74) for placebo plus azacitidine (p < 0.0001).
- CR + complete remission with partial hematologic recovery rate (CR + CRh rate) was 52.8% (n=38/72) for TIBSOVO in combination with azacitidine vs. 17.6% (n=13/74) for placebo plus azacitidine (p < 0.0001).
- Objective response rate (ORR) was 62.5% (n=45/72) for TIBSOVO in combination with azacitidine vs. 18.9% (n=14/74) for placebo plus azacitidine (p < 0.0001).
“We are excited about the potential to bring a new treatment option to patients with previously untreated IDH1-mutated AML. This further extends the significant clinical benefit for patients with acute myeloid leukemia and IDH1 mutations,” said Patrick Therasse, M.D., Ph.D., Vice President, Head of Late Stage and Life Cycle Management in Oncology and Immuno-Oncology Therapeutic Area, Servier Group.
Acute myeloid leukemia is a rapidly progressing type of cancer, and the prognosis is often poor,” said Stephane De Botton, M.D. Ph.D., Principle Investigator and Head of Multidisciplinary Hematology Committee at the Institut Gustave Roussy, Villejuif, France. “Our goal with treatment is to prolong overall survival, and the impressive clinical benefit following treatment with TIBSOVO in combination with azacitidine is incredibly promising for these patients with previously untreated IDH1-mutated acute myeloid leukemia.”
Common all-grade adverse events (AEs) occurring in more than 20 percent of patients receiving TIBSOVO in combination with azacitidine vs. placebo plus azacitidine were nausea (42.3% vs. 38.4%), vomiting (40.8% vs 26.0%), diarrhea (35.2% vs 35.6%), pyrexia (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%).
The AGILE study has halted further enrollment due to compelling efficacy data for TIBSOVO.
Servier is in discussions with regulatory health authorities regarding submissions to expand the currently approved indications for TIBSOVO.
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, TIBSOVO was approved as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma.
Please see Full Prescribing Information, including BOXED WARNING for AML patients.