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    Home > Medical News > Latest Medical News > New clinical data for the Phase III clinical phase of the Perjeta-Herceptin fixed-dose combination were published.

    New clinical data for the Phase III clinical phase of the Perjeta-Herceptin fixed-dose combination were published.

    • Last Update: 2020-08-02
    • Source: Internet
    • Author: User
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    On December 11, 2019, Genentech, a company of Roche, announced at the SABCS conference that the latest data from Perjeta and Herceptin fixed-dose combination of combination chemotherapy for herr2-plus early breast cancer Phase III clinical study FeDeriCa, compared with the standard intravenous Perjeta-Herceptin combined chemotherapy treatment regimen, and the level of Perjeta in the blood showed non-inefficeenance.
    In addition, a fixed-dose combination scheme can be administered in minutes, while an intravenous programme often takes 1-2 hours, providing great convenience to patients.
    Perjeta (Patujumonodyagain) and Herceptin (quorbead monotortagain) are the same human-derived monoclonal antibody drugs that belong to the target human epidermal growth factor 2 receptor (HER2), the difference is that the two have different sites of action on HER2, the two can form complementary and play a better role.
    in patients with HER2-positive early breast cancer who received new assisted therapy (preoperative), Perjeta-Herceptin combined chemotherapy doubled the patient's pathological total remission rate compared to a separate Herceptin combination chemotherapy regimen.
    adding Perjeta to HER2 plus early-stage breast cancer treatment program Herceptin-chemotherapy reduced the risk of recurrence or patient death by 24%, based on the latest results from Roche's latest analysis of the Clinical Phase III study.
    Since December 20, 2017, the FDA has approved Perjeta-Herceptin intravenous chemotherapy as an auxiliary treatment for early-stage breast cancer with a high risk of recurrence, the "Perjeta-Herceptin-chemotherapy" dual-target intravenous injection regimen has become the standard treatment for HER2-plus breast cancer patients.
    , December 11, 2019, Genentech released the latest data on FeDeriCa, a clinical study on her2 plus early breast cancer Phase III, for the treatment of "Perjeta and Herceptin and Chemotherapy".
    results showed that the Perjeta-Herceptin fixed-dose combination combination of subcutaneous combination chemotherapy programmes had achieved similar efficacy and safety compared to the standard intravenous Perjeta-Herceptin combined chemotherapy regimen, and the level of jetPera in the blood also showed non-poor efficacy and reached the primary endpoint.
    Perjeta-Herceptin fixed-dose combination is a new Type SC dosage that combines Perjeta, Herceptin and Halozyme Therapeutics' Enhanze drug delivery technology to provide patients with medication convenience compared to intravenous injections.
    FeDeriCa is an international, multi-center, two-arm, randomized, open-label study conducted in 500 HER2-positive early-stage breast cancer (eBC) patients undergoing new complementary therapy (preoperative) and assisted therapy (postoperative) to assess the pharmacokinetic, efficacy and safety of the Perjeta-Herceptin injection combination chemotherapy (SC) injection. the main endpoint of
    FeDeriCa is the lowest level of Perjeta in the blood during a given dosing interval.
    secondary endpoints include safety, the lowest level of Herceptin in blood given to the time interval between administration, and pathology complete remission.
    According to the latest data released by Genentech, the FeDeriCa trial reached the primary and secondary endpoints, with perjeta-Herceptin fixed-dose combination SC injection combined chemotherapy regimen seeking a similar effect to perjeta-Herceptin IV injection combined chemotherapy regimen Results, the specific data are as follows: 1) Main endpoint: Compared to the Perjeta-Herceptin IV scheme, perjeta-Herceptin SC regimen shows non-poor efficacy in the blood during the given dosing interval. the geometric mean ratio (GMR) for the main endpoint of
    is 1.22 (90% CI: 1.14 to 1.31), and the 90% CI lower limit of 1.14 is still greater than the pre-given non-degradation standard of 0.80.
    2) Secondary endpoint I: In the Perjeta-Herceptin SC scenario, the Herceptin level in the blood during a given dosage interval shows non-poor efficacy, with a GMR of 1.22 (90% CI: 1.14 to 1.31) and a pre-given non-degradation standard of 0.80.
    3) Secondary Endpoint II: Two treatment options showcomparable pathological complete remission (pCR), pCR of 59.5% and 59.7% in IV and SC programmes, respectively, with a difference of 0.15% (95% CI: -8.67 to 8.97).
    in terms of safety data, perjeta-Herceptin fixed-dose SC-regime combined chemotherapy data were similar to those of the Perjeta-Herceptin IV programme, and no new adverse reactions were found, the most common adverse reactions being hair loss, nausea, diarrhea and anaemia.
    currently, the standard IV injection load dose of Perjeta-Herceptin takes about 150 minutes, and subsequent maintenance of infusions takes about 60-150 minutes.
    the above-mentioned study of The Perjeta-Herceptin fixed-dose SC preparation in FeDeriCa took only about 8 minutes, and the subsequent maintenance of the administration took only about 5 minutes.
    this is an important advantage of Perjeta-Herceptin fixed-dose SC preparations and a strategy for Roche to secure Herceptin sales.
    hit by biosimilars, it is now mainly in The European market, and Herceptin's sales have continued to decline in recent years.
    this year, the U.S. is also on the market for Herceptin biosimilars, with Kanjinti becoming the first Herceptin biosimilar to be sold in the U.S. in July 2019, followed by Ogilivi on December 2, 2019, and a third is expected tomorrow in February.
    the onset of biosimilars, which continue to hit Herceptin's sales, the Perjeta-Herceptin joint programme is expected to ease the process.
    FDA-approved Herceptin Biosimilar Stakes Reference Source: 'S fixed-dose subcutanewithdive-petela and Herceptin-matchto-peedy-hes in people with Her2-breast-positive cancer Source: Development of TheIA, Perjeta-Herceptin Fixed Dose Combination Phase III Clinical Lybsion New Data.
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