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    Home > Medical News > Latest Medical News > CStone Pharmaceuticals announced the CS1002 (anti-CTLA-4 monoclonal antibody) and CS1003 (anti-PD-1 monoclonal antibody) phase Ib study data in patients with advanced solid tumors at the 2021 ESMO annual meeting

    CStone Pharmaceuticals announced the CS1002 (anti-CTLA-4 monoclonal antibody) and CS1003 (anti-PD-1 monoclonal antibody) phase Ib study data in patients with advanced solid tumors at the 2021 ESMO annual meeting

    • Last Update: 2021-10-11
    • Source: Internet
    • Author: User
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    Suzhou, China, September 19, 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, At the 2021 European Society of Medical Oncology (ESMO) annual meeting, a phase Ib study of CS1002 (anti-CTLA-4 monoclonal antibody) and CS1003 (anti-PD-1 monoclonal antibody) in patients with advanced solid tumors was announced (CS1002- 101, NCT03523819) preliminary results (Poster ID: 981P)
    .
    Research data shows that the combination of CS1002 and CS1003 immune checkpoint inhibitors can treat patients with high microsatellite unstable (MSI-H)/mismatch repair defects (dMMR) solid tumors who have not received anti-PD(L)1 treatment with Among melanoma patients whose anti-PD (L)1 treatment failed, all showed good safety and encouraging anti-tumor activity

    .

    The CS1002-101 study is a multi-center, open-label, dose-escalation and dose-expansion phase Ia/Ib study, which aims to evaluate the clinical safety of CS1002 monotherapy (phase Ia) and combination therapy with CS1003 (phase Ib) , Tolerance, pharmacokinetic characteristics and preliminary anti-tumor activity
    .

    In the phase Ib dose escalation part, the combination of four different dosing regimens of CS1002 and CS1003 was explored in patients with advanced solid tumors.
    No dose-limiting toxicity (DLT) was observed, and the maximum tolerated dose (MTD) was not reached

    .

    In the phase Ib dose expansion part, CS1003 (200mg fixed dose, 200mg fixed dose, Q3W) The effectiveness and safety of CS1002 in combination with two dose levels, namely the regular dose of CS1002 (1 mg/kg Q3W, up to 4 doses, group A), and the lower dose of CS1002 (0.
    3 mg/kg Q6W, Group B)

    .

    As of March 1, 2021, of the 16 evaluable MSI-H/dMMR solid tumor patients in groups A and B, the overall objective response rate (ORR) was 50%
    .
    Among them, among the 9 patients in group A, 4 patients (44.
    4%) achieved partial remission (PR), among the 7 patients in group B, 1 patient achieved complete remission (CR), and 3 patients achieved PR

    .
    In a total of 8 evaluable melanoma patients in group A and group B, the overall ORR was 50%, and 2 patients in each group achieved PR

    .

    A total of 33 patients participated in the safety analysis, and 29 patients (87.
    9%) reported at least one adverse event (AE)

    .
    21 (63.
    6%) of patients reported treatment-related adverse events (TRAE), wherein 5 cases (15.
    2%) of> / = grade 3 TRAE, A group 2 patients, Group B 3 embodiment

    .
    The most common TRAEs are diarrhea, fatigue and rash

    .

    Therefore, the combination therapy of anti-CTLA-4 mAb CS1002 and anti-PD-1 mAb CS1003 showed excellent and sustainable initial anti-tumor activity in the above two tumor types, regardless of the dose level of CS1002
    .
    Among them, the lower dose group of CS1002 (0.
    3mg/kg, Q6W) may have better safety

    .

    Dr.
    Xie Yizhao, Chief Scientific Officer of CStone Pharmaceuticals, said: “CTLA-4 is an important negative regulator of T cell activation

    .
    A number of clinical studies targeting CTLA-4 are underway at home and abroad, and currently there is only one targeting CTLA-4.
    Dian’s monoclonal antibody drug was approved for marketing

    .
    This combination of CS1002 and CS1003 is used in patients with MSI-H/dMMR solid tumors who have not received anti-PD(L)1 treatment and melanoma patients who have failed anti-PD(L)1 treatment The clinical efficacy data in, are encouraging and show good safety

    .
    These data support the further clinical development of CS1002 and CS1003 combination therapy

    .
    "

    About CS1002 (anti-CTLA-4 monoclonal antibody)

    CS1002 is an anti-CTLA-4 monoclonal antibody developed by CStone Pharmaceuticals
    .
    CTLA-4, also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene

    .
    CTLA-4 can inhibit the activation of T cells by binding to its ligand B7.
    1/B7.
    2 molecules to protect tumor cells from T lymphocytes

    .
    Therefore, blocking the immune effect of CTLA-4 can stimulate the proliferation of immune cells, thereby inducing or enhancing the anti-tumor immune response

    .
    CTLA-4 provides a new method for the immunotherapy of many diseases including tumors

    .

    About CS1003 (anti-PD-1 monoclonal antibody)

    CS1003 is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1), which is being developed for immunotherapy of a variety of tumors
    .
    Compared with most of the monoclonal antibodies that bind human and monkey PD-1 that have been approved or are in clinical trials, CS1003 has high affinity to human, cynomolgus and mouse PD-1 and can block PD-1 Interaction with PD-L1 and PD-L2 ligands

    .
     

    About CStone Pharmaceuticals

    CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616) is a biopharmaceutical company that focuses on 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
    .
    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

    .
    With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor drug candidates

    .
    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

    .
    Many late-stage drug candidates are in critical clinical trials or registration stages

    .
    CStone's vision is to become a world-renowned biopharmaceutical company, leading the way to overcome cancer

    .

    For more information, 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 statement is made in this article
    .
    Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether there are new data, future events or other circumstances

    .
    Please read this article carefully and understand that our actual future results or performance may differ materially from expectations

    .
    All statements in this article are made on the date of publication of this article and may change due to future developments

    .

    Source: CStone Pharmaceuticals

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