SUZHOU,China, August 4th, 2021– The partner of CStone Pharmaceuticals (“CStone”, HKEX: 2616), Servier, a global pharmaceutical company, announced the global Phase 3 double blinded placebo controlled AGILE study of TIBSOVO® (ivosidenib tablets) in combination with the chemotherapy azacitidine in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) met its primary endpoint of event-free survival (EFS) 1,2. Treatment with TIBSOVO in combination with azacitidine compared to azacitidine in combination with placebo demonstrated a statistically significant improvement in EFS. Additionally, the trial met all of its key secondary endpoints, including complete remission rate (CR rate), overall survival (OS), CR and complete remission with partial hematologic recovery rate (CRh rate) and objective response rate (ORR). The safety profile of TIBSOVO in combination with azacitidine was consistent with previously published data. The study recently halted further enrollment based on the recommendation of the Independent Data Monitoring Committee (IDMC), as a difference of clinical importance was noted between the treatment groups.
A full analysis of the AGILE trial will be submitted for a presentation at a future medical congress. The findings from this study will be shared with the medical community and with regulatory authorities around the world.
On July 19th 2019, CStone announced that the first patient was dosed in AGILE, the global registrational Phase III study of ivosidenib in China. 12 centers in China participated in this study so far.
Professor Wang Jianxiang from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, the Principal Investigator of AGILE in China, said, “Older newly diagnosed AML patients and patients with conditions that preclude the use of intensive induction chemotherapy often have poor clinical outcomes. Novel effective therapies are urgently needed for those patients. The positive results of AGILE are of great significance for patients with treatment-naïve AML with a suspectable IDH1 mutation. It can improve the prognosis and bring new hope for these patients.”
Dr. Jason Yang, Chief Medical Officer of CStone, said, “We are pleased to see the study recently halted further enrollment due to compelling efficacy data for ivosidenib. The success of AGILE marks a major breakthrough in the treatment of AML. Ivosidenib in combination with azacitidine demonstrated statistically significant improvement in the primary endpoint EFS and all secondary endpoints in newly diagnosed AML patients with a suspectable IDH1 mutation who have conditions that preclude the use of intensive chemotherapy. We’d like to thank all investigators, patients and their families involved in the AGILE study, and we will engage with the National Medical Products Administration (NMPA) of China to help Chinese patients have access to this innovative therapy as early as possible.”
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, the U.S. Food and Drug Administration (FDA) accepted the Servier's supplemental New Drug Application (sNDA) for TIBSOVO as a potential treatment for patients with previously treated IDH1-mutated cholangiocarcinoma. The sNDA was granted Priority Review by the FDA.
Servier has an exclusive collaboration and license agreement with CStone for the development and commercialization of TIBSOVO in Mainland China, Taiwan, Hong Kong, Macau and Singapore.
Meanwhile, the National Medical Products Administration of China has accepted the NDA of TIBSOVO® (ivosidenib tablets) in adult patients with R/R AML who have a susceptible IDH1 mutation and this NDA has been granted priority review.
About AGILE Phase 3 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 to placebo in combination with azacytidine, in newly diagnosed AML patients non eligible for intensive chemotherapy. The study’s primary endpoint is 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.
Other key secondary endpoints included complete remission rate (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 a cancer of the blood and bone marrow marked by rapid disease progression and is the most common acute leukemia affecting adults with approximately 20,000 new cases in the U.S., and 43,000 cases in Europe each year3,4. The majority of patients with AML eventually relapse. Relapsed or refractory AML has a poor prognosis5. The five-year survival rate is approximately 27%3. For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia6.
About TIBSOVO® (ivosidenib tablets)
TIBSOVO® is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:
About CStone
CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received three drug approvals in Greater China, including two in Mainland China and one in Taiwan. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.
For more information about CStone, please visit: www.cstonepharma.com.
Forward-looking statement
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