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  • CStone’s partner, Servier, will present the first Phase 3 results from the global AGILE study of TIBSOVO® (ivosidenib tablets) in combination with azacitidine in patients with previously untreated IDH1-mutated acute myeloid leukemia in an oral presentation at the 2021 ASH annual meeting

    Times:2021.11.05   Author:CStone

    SUZHOU, China, November 5th, 2021–The partner of CStone Pharmaceuticals (“CStone”, HKEX: 2616), Servier, announced that the data from the global, Phase 3 double-blind 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) will be reported in an oral presentation at the upcoming 2021 American Society of Hematology (ASH) Annual Meeting and Exposition, December 11-14, 2021. The findings show improved event-free survival and key secondary outcomes, including complete remission, overall survival and objective response rate, with TIBSOVO® in combination with azacitidine compared to azacitidine plus placebo.

    • Abstract Title: AGILE: A Global, Randomized, Double-Blind, Phase 3 Study of Ivosidenib + Azacitidine Versus Placebo + Azacitidine in Patients with Newly Diagnosed Acute Myeloid Leukemia
    • Author: Pau Montesinos, M.D., Ph.D., Et Al.
    • Presentation type: Oral Presentation Abstract #697
    • Session Title: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Targeted Therapies and Novel Therapies
    • Session Time: Monday, December 13, 2021 at 2:45 - 4:15 PM EST time

    Dr. Jason Yang, Chief Medical Officer of CStone, said: “As Servier’s close Asian partner and a key part of the AGILE global study, we are pleased to see the AGILE study including Chinese AML patients will be reported in an oral presentation at the upcoming 2021 ASH. The success of AGILE marks a major breakthrough in the treatment of AML. We will work closely 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, TIBSOVO® was approved as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma. Meanwhile, the NMPA of China has accepted the new drug application (NDA) of TIBSOVO® in adult patients with R/R AML who have a susceptible IDH1 mutation and this NDA has been granted priority review.

    Servier has an exclusive license agreement with CStone for the development and commercialization of TIBSOVO® in Mainland China, Taiwan, Hong Kong, Macau and Singapore.

    ***

    About 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 to placebo in combination with azacitidine, in patients with newly diagnosed IDH1 mutant AML who are not candidates 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.

    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).

    On July 19th,2019, CStone announced that the first patient was dosed in AGILE, the global registrational Phase III study of ivosidenib in China. 16 centers in China participated in this study.

    About Acute Myeloid Leukemia (AML)

    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 year. The majority of patients with AML eventually relapse. Relapsed or refractory AML has a poor prognosis. The five-year survival rate is approximately 27%. For 6 to 10 percent of AML patients, the mutated IDH1 enzyme blocks normal blood stem cell differentiation, contributing to the genesis of acute leukemia.

    About TIBSOVO® (ivosidenib tablets)

    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.

    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: .

    Forward-looking statement

    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.

    References

    1. Data on file. Servier. July 30, 2021
    2. ClinicalTrials.gov. Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE). Available at: https://clinicaltrials.gov/ct2/show/NCT03173248. Last accessed: July 2021.
    3. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html. Last accessed: July 2021.
    4. American Cancer Society. Acute Myeloid Leukemia (AML). https://www.cancer.org/content/dam/CRC/PDF/Public/8674.00.pdf. Accessed July 2021.
    5. Kumar C. Genetic Abnormalities and Challenges in the Treatment of Acute Myeloid Leukemia. Genes Cancer. 2011; 2:95-107.
    6. DiNardo CD, Stein EM, de Botton S, et al. Durable Remissions from Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med 2018;378:2386-98.

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