ESMO 2021 CStone Pharmaceuticals announces the clinical data of the Chinese registration bridging study of Afnib in patients with relapsed/refractory acute myeloid leukemia who are susceptible to IDH1 mutations

Efficacy data show that Avonib has excellent clinical efficacy in the treatment of adult Chinese patients with relapsed or refractory acute myeloid leukemia (R/R AML) who are susceptible to IDH1 mutations; Avonib is well tolerated , Safety is controllable.

Suzhou, China, September 20, 2021/PRNewswire/ - CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616), a leading biopharmaceutical company focusing on research, development and commercialization of innovative tumor immunotherapies and precision therapeutic drugs, It was announced today that the company announced the clinical data of the first-of-its-kind drug Afnibu China-registered bridging study CS3010-101 at the 2021 European Society of Medical Oncology (ESMO) annual meeting in the form of a preferred paper presentation

The CS3010-101 China Bridging Study is a phase I, multi-center, single-arm study being conducted in China

Research Field: Hematological Malignancies Date: September 20, 2021 19:30-19:40 (Beijing time) Report format: Proffered Paper Presentation Topic: A report on the susceptibility of carrying avnib Results of bridging study in Chinese patients with relapsed/refractory acute myeloid leukemia (R/R AML) with citrate dehydrogenase-1 (IDH1) mutation Report number: 825O Principal investigator: Report by Professor Wang Jianxiang, Hospital of Hematology, Chinese Academy of Medical Sciences Person: Dr.

Efficacy: Afnib shows excellent clinical efficacy in the treatment of adult R/R AML Chinese patients with susceptible IDH1 mutations

Among the 30 evaluable patients, the primary efficacy endpoint complete remission and complete remission with partial hematological recovery (CR+CRh) rate was 36.

Safety: Afnibu is well tolerated and safety is controllable

The incidence of adverse events (TEAE) above grade 3 is 86.

The main investigator of the CS3010-101 study, Professor Wang Jianxiang from the Hospital of Hematology, Chinese Academy of Medical Sciences, said: “The existing treatments for AML patients with IDH1 mutations are limited, the 5-year survival rate is low, and the patient’s quality of life is poor

Dr.

In 2020, Afnibu was included in the “List of New Drugs Urgently Needed in Clinical Medicine (third batch)” by the Drug Evaluation Center of the National Medical Products Administration, and obtained the qualification for fast-track review and approval

In July 2021, Afnib's registration bridging study CS3010-101 in China reached the expected end point.

In August 2021, NMPA accepted Afnib's new drug marketing application and included it in priority review for the treatment of adult R/R AML patients with IDH1 susceptible mutations

About Ivosidenib

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In August 2021, Servier, a global independent pharmaceutical group managed by a non-profit fund, announced that avonib and the chemotherapy drug azacitidine will be combined to treat previously untreated adult patients with IDH1 mutant AML.

In August 2021, Servier announced that Afnib has been approved by the US FDA for use in previously treated adult patients with locally advanced or metastatic cholangiocarcinoma with IDH1 mutations detected by the FDA-approved testing method

Afnib has been approved by the US FDA for single-drug treatment of adult R/R AML patients with IDH1 susceptible mutations and newly diagnosed patients ≥75 years of age or those who cannot use intensive chemotherapy due to other comorbidities with IDH1 susceptible mutations Of adult patients with AML

Servier and CStone Pharmaceuticals have carried out exclusive cooperation in the clinical development and commercialization of Avnib in Greater China, including Mainland China, Hong Kong, Taiwan and Macau, and Singapore, according to the licensing agreement

About CStone Pharmaceuticals

CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616) is a biopharmaceutical company that focuses on the research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
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Established at the end of 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercial operations
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With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor drug candidates
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At present, CStone Pharmaceuticals has obtained three new drug marketing approvals worldwide, two new drug marketing approvals in Mainland China, and one new drug marketing approval in Taiwan
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Many late-stage drug candidates are in critical clinical trials or registration stages
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CStone's vision is to become a world-renowned biopharmaceutical company, leading the way to overcome cancer
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For more information, please visit
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Source: CStone Pharmaceuticals