The new data further demonstrate the significant clinical and survival benefits of first-line treatment with TIBSOVO and azacitidine for patients with IDH1-mutated AML. As the first IDH1 mutation specific targeted therapy to demonstrate improved overall survival (OS) in combination with azacitidine compared to azacitidine plus placebo, TIBSOVO was also recently approved by the
The AGILE trial is a global Phase 3 double blinded placebo-controlled study of TIBSOVO in combination with azacitidine vs. azacitidine plus placebo in adults with previously untreated IDH1-mutated AML who were ineligible to receive intensive chemotherapy. TIBSOVO in combination with azacitidine demonstrated a three-fold improvement in median OS (24 months) compared to azacitidine plus placebo (7.9 months) as a first-line treatment for IDH1-mutated AML (HR: 0.44; p=0.0005). In long-term follow-up data as of
Clinical and molecular characteristics among patients who achieved an exceptional response included a low mutational burden, lack of receptor tyrosine kinase (RTK) pathway mutations and canonical AML drivers, and co-occurrence of mutations associated with clonal hematopoiesis appear to be associated with exceptional response.
TIBSOVO is currently approved in the
About the NCT03173248 AGILE Phase 3 AML 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 with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (75 years old or who have comorbidities that preclude the use of intensive induction 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.
Key secondary endpoints included 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 the most common leukemia in the adult population, affecting 80% of adults with leukemia[1],[2]AML is characterized by clonal expansion of immature blast cells in the peripheral blood and bone marrow resulting in ineffective erythropoiesis and bone marrow failure.1,[3],[4] In the US, the incidence is over 20,000 cases per year, with the average age at diagnosis being 65 years.1 The global incidence of AML increased by 87.3% from 1990 to 2017, with a higher incidence in males than females.[5] The overall prognosis for patients with AML is poor; the 5-year relative survival is 30.5% (2012-2015).[6] Untreated, death usually ensues within months of diagnosis secondary to infection or bleeding.2 Even with current treatments, as many as 70% of patients aged 65 years will die within 1 year of diagnosis.2
About TIBSOVO (ivosidenib tablets)
TIBSOVO is an oral targeted IDH1 inhibitor. The NMPA of
TIBSOVO is approved in the
Relapsed or Refractory AML: For the treatment of adult patients with relapsed or refractory AML
Locally Advanced or Metastatic Cholangiocarcinoma: For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated
TIBSOVO is also approved by the
About CStone
CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in
Forward-looking statements
The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments.
Contact:
Email: ir@cstonepharma.com
(C) 2023 Electronic News Publishing, source