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    Home > Biochemistry News > Biotechnology News > AstraZeneca/Daisankyo's heavy ADC welcomes a breakthrough again!

    AstraZeneca/Daisankyo's heavy ADC welcomes a breakthrough again!

    • Last Update: 2022-05-24
    • Source: Internet
    • Author: User
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    On February 21, AstraZeneca and Daiichi Sankyo announced that Enhertu, an antibody-drug conjugate (ADC) jointly developed by the two parties, achieved positive results in the pivotal Phase 3 trial DESTINY-Breast04
    .
    Data showed that Enhertu significantly improved progression-free survival (PFS) and overall survival (OS) compared with chemotherapy in patients with HER2-low, unresectable and/or metastatic breast cancer, regardless of hormonal exposure.
    body (HR) status

    .
    According to the press release, this is Enhertu's first Phase 3 results in patients with HER2-low, metastatic breast cancer

    .

    According to public information, Enhertu (trastuzumab deruxtecan, DS-8201) is an ADC drug designed using Daiichi Sankyo's proprietary DXd ADC technology platform
    .
    It links the human HER2 antibody trastuzumab to a novel topoisomerase 1 inhibitor via a tetrapeptide linker to target cancer cells and deliver the drug inside the cells

    .
    Enhertu has previously been FDA-approved for the third-line treatment of previously treated patients with unresectable or metastatic HER2-positive breast cancer, as well as HER2-positive locally advanced or metastatic gastric cancer and gastroesophageal junction (GEJ) previously treated with trastuzumab-based therapy.
    adenocarcinoma patients

    .

    The DESTINY-Breast04 trial announced this time is a global, randomized, open-label, registration phase 3 trial designed to evaluate Enhertu (5.
    4 mg/kg) versus chemotherapy (capecitabine, eribulin, gemcitabine, Compared with paclitaxel or nab-paclitaxel), efficacy and safety in patients with HER2-low expression, unresectable and/or metastatic breast cancer

    .
    All patients in the trial had HER2 testing and had received one or two prior chemotherapy regimens

    .

    Patients were randomized 2:1 to receive either Enhertu or chemotherapy, the primary endpoint was PFS in patients with HR-positive disease based on a blinded independent central review (BICR), and key secondary endpoints included all patients (regardless of HR status) based on BICR of PFS, OS in patients with HR-positive disease, and OS in all patients
    .

    Image source: Daiichi Sankyo official website

    Results showed that DESTINY-Breast04 met its primary endpoint, with Enhertu demonstrating superior PFS compared to standard chemotherapy in previously treated patients with HR-positive, HER2-low metastatic breast cancer
    .
    The trial met the key secondary endpoint of PFS regardless of patient HR status (HR positive or HR negative)

    .
    The trial also met key secondary endpoints of OS in patients with HR-positive disease, and OS in all patients

    .
    In addition, the safety profile observed by Enhertu in this study was consistent with previous clinical trials and no new safety concerns were identified

    .

    Breast cancer is one of the most common cancers in women worldwide and the most common cause of cancer death in women
    .
    According to statistics, about 20% of breast cancers are HER2 positive

    .
    HER2 expressed on the surface of cancer cells is related to disease progression and poor prognosis.
    Several drugs targeting HER2 have been approved, and patients with HER2-positive metastatic breast cancer have benefited and improved survival

    .

    However, about 80% of breast cancers are classified as HER2-negative, and in more than 40% of them, cancer cells express HER2 at low levels in the form of surface antigens
    .
    There are currently no approved antibody therapies for such tumors with low HER2 expression

    .
    Existing clinical guidelines classify these patients as being HER2-negative, and many patients are ultimately limited to alternative therapies after progressing with existing treatments

    .

    It is hoped that the ADC product jointly developed by AstraZeneca and Daiichi Sankyo will make more progress in clinical research and bring clinical benefits to more cancer patients as soon as possible
    .

    references:

    [1] Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer , Retrieved February 21, 2022, from https:// -releases/2022/enhertu-improves-pfs-and-os-in-her2-low-bc.
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