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    Home > Active Ingredient News > Antitumor Therapy > PD-L1/CTLA-4 bispecific antibody!

    PD-L1/CTLA-4 bispecific antibody!

    • Last Update: 2021-04-17
    • Source: Internet
    • Author: User
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    News on April 14, 2021 // - Corning Jerry Biopharmaceuticals (Alphamab Oncology, hereinafter referred to as "Corning Jerry") recently announced at the American Association for Cancer Research (AACR) 2021 annual meeting that KN046 combined with nab-paclitaxel for the treatment of metastatic disease Data from a Phase 1b/2 phase clinical study ( clinical trial number: KN046-203; NCT03872791) in patients with triple negative breast cancer (mTNBC) .
    Breast cancer clinical trials


    KN046-203 is a phase 1b/2, open-label, multi-center clinical study that is evaluating the efficacy, safety and tolerability of KN046 combined with albumin-bound paclitaxel in the treatment of TNBC patients.
    The study enrolled 27 female patients who had not yet been systematically treated (naïve) for locally advanced unresectable or metastatic TNBC.


    The results show that the combination of KN046 and albumin-bound paclitaxel has good tolerability and efficacy, especially in PD-L1-positive mTNBC patients, showing progression-free survival (PFS) and overall survival (OS) Potentially clinically significant benefits.


    As of March 8, 2021, among 25 patients with evaluable TNBC, the objective response rate (ORR) was 40.
    0%, and the disease control rate (DCR) was 96.
    0%.
    The median follow-up time was 13.
    7 months.
    In the intention-to-treat (ITT) population, the median progression-free survival (mPFS) was 7.
    3 months (95%CI: 3.
    7-unestimable [NE]), and the 12-month PFS rate was 38.
    7% (95%CI: 17.
    9) %-59.
    3%), the median overall survival (mOS) has not yet been reached, and the 15-month OS rate is 73.
    4% (95%CI: 46.
    1-88.
    4%).
    In PD-L1 positive (IC PD-L1≥1%) patients, mPFS was 13.
    8 months (95%CI: 1.
    6-NE), and the 12-month PFS rate was 54.
    9% (95%CI: 18.
    7%-80.
    6%) ), mOS has not yet reached, the 15-month OS rate was 77.
    1% (95%CI: 34.
    5-93.
    9%).


    KN046-203 trial efficacy data (click on the picture to see a larger picture)


    As of March 8, 2021, there were no treatment-related adverse events (TRAE) that resulted in deaths, and grade 3/4 TRAEs occurred in 13 patients (48.
    1%).
    Eleven patients (40.
    7%) had immune-related adverse events (irAE).
    Except for 2 cases of grade 3 immune-mediated liver disease and 1 case of grade 3 rash in 3 patients, all irAEs were grade 1 or 2.


    Breast cancer is the Chinese and global women the most common malignant tumor .
    Triple negative breast cancer (TNBC) accounts for about 15% of all breast cancers, and has the highest metastasis rate and the worst overall survival rate among all subtypes of breast cancer.
    Tumor


    In the KN046-203 trial, KN046 combined with albumin-bound paclitaxel in the treatment of TNBC showed encouraging progression-free survival (PFS) and overall survival (OS) data, indicating good clinical benefits for TNBC patients.


    KN046 mechanism of action


    KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
    Its innovative design includes the fusion of CTLA-4 and PD-L1 single domain antibodies with different mechanisms; it can be targeted and enriched in PD- The tumor microenvironment with high expression of L1 and the elimination
    of regulatory T cells (Treg) that inhibit
    tumor immunity.
    Tumor


    KN046 has carried out nearly 20 clinical trials in different stages covering more than 10 types of tumors such as non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, liver cancer , and pancreatic cancer in Australia and China .
    The test results show that patients have the advantage of survival benefit.
    .
    Based on the clinical trial results obtained in Australia and China, the US
    FDA approved KN046 to directly enter Phase 2 clinical trials in the United States , and granted KN046 the orphan drug designation for the treatment of thymic epithelial tumors in September 2020 .
    Currently, two registered
    clinical trials of KN046 are in progress.
    ()
    Liver Cancer FDA Clinical Trials Tumor Clinical Trials


    Original source: Alphamab Oncology Presented Clinical Data of KN046 Combined with Nab-paclitaxel in the Treatment of mTNBC at AACR 2021
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