Suzhou, China, May 29, 2023 –The partner of CStone Pharmaceuticals (“CStone”, HKEX: 2616) Servier announced that they will showcase new data for TIBSOVO® (ivosidenib) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Annual Meeting.
Data to be presented at ASCO meeting (June 2-6, Chicago) include:
Abstracts being presented at ASCO are listed below (all times in Central Time) and are available online on the ASCO website here.
Abstract #7012: Updated efficacy and safety data from the AGILE study in patients with newly-diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine
Abstract #11532: Phase I study of the mutant IDH1 inhibitor ivosidenib: long-term safety and clinical activity in patients with conventional chondrosarcoma
Abstract #7036: Clinical and molecular characteristics of AML patients with an exceptional response to ivosidenib
Additionally, at the EHA annual meeting in Frankfurt, Germany, from June 8-11, Servier will present three posters for TIBSOVO, including updated substudy results for ivosidenib in IDH1-mutant relapsed/refractory myelodysplastic syndrome (MDS). Servier abstracts being presented at EHA are listed below (all times in Central European Summer Time) and are available online on the EHA website here.
Abstract #P490: Updated efficacy and safety data from the AGILE study in patients with newly-diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine
Abstract #P441: Clinical and molecular characteristics of AML patients with an exceptional response to ivosidenib
Abstract #P724: Updated substudy results for ivosidenib in IDH1-mutant relapsed/refractory myelodysplastic syndrome
About TIBSOVO® (ivosidenib tablets)
TIBSOVO is an oral targeted IDH1 inhibitor. The NMPA of China has approved the NDA of TIBSOVO for the treatment of adult patients with relapsed/refractory acute myeloid leukemia who have a susceptible IDH1 mutation.
TIBSOVO is approved in the U.S.for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with:
Tibsovo is also approved by the European Commission as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Servier has granted an exclusive license to CStone to develop and commercialize the product in Mainland China, Taiwan, Hong Kong, Macau and Singapore.
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 China and worldwide. Established in 2015, CStone has assembled a 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 ten NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone’s vision is to bring innovative oncology therapies to cancer patients worldwide.
For more information about CStone, please visit www.cstonepharma.com.
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