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    Home > Biochemistry News > Biotechnology News > The U.S. Food and Drug Administration (FDA) approves Opdivo(R) (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of selected adult patients with resectable non-small cell lung cancer

    The U.S. Food and Drug Administration (FDA) approves Opdivo(R) (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of selected adult patients with resectable non-small cell lung cancer

    • Last Update: 2022-05-23
    • Source: Internet
    • Author: User
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    SHANGHAI, March 6, 2022 /PRNewswire/ -- On March 4, 2022, Bristol-Myers Squibb (announced that the U.
    Food and Drug Administration (FDA) has approved Opdivo® (nivolumab) 360 mg (intravenous) in combination with platinum-containing doublet chemotherapy (one cycle every three weeks for a total of three cycles) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) with tumors ≥ 4 cm or node-positive disease,

    The approval is based on the results of the CheckMate-816 clinical study, which is the first phase III clinical trial to achieve positive results in the preoperative treatment of resectable NSCLC based on immunotherapy, regardless of the patient's PD-L1 expression level
    The primary study endpoints include event-free survival (EFS) and pathological complete response (pCR)

    The study endpoints were independently blinded and assessed

    Another efficacy outcome of the study was overall survival (OS)

    The study compared Navoliu The efficacy of monoclonal antibody combined with platinum-containing doublet chemotherapy (n=179) and platinum-containing doublet chemotherapy alone (n=179)


    In this clinical trial, preoperative use of nivolumab in combination with chemotherapy demonstrated a statistically significant improvement in event-free survival (EFS) compared with chemotherapy alone37 % (HR 0.
    63; 95% CI: 0.
    87; P=0.

    Median event-free survival was 31.
    6 months (95% CI: 30.
    2-not reached) in the nivolumab-chemotherapy group and 20.
    8 months (95% CI: 14.
    7) in the chemotherapy-alone group

    In addition, 24% of patients in the nivolumab-chemotherapy group achieved a pathological complete response (95% CI: 18.
    0) versus 2.
    2% in the chemotherapy-alone group (95% CI: 0.
    6; estimated treatment difference: 21.
    6; 95% CI: 15.
    2; P<0.

    A prespecified interim analysis of overall survival showed an HR of 0.
    57 (95% CI: 0.
    87), which had not crossed the border of statistical significance


    "Considering that a large proportion of patients with resectable non-small cell lung cancer will have a postoperative recurrence occurs, so preoperative treatment is expected to help patients improve their chances of success with surgery while reducing the risk of cancer recurrence
    For how we treat resectable NSCLC, the combination of nivolumab and platinum-based doublet chemotherapy The approval is an important turning point in enabling us to use immunocombination chemotherapy for neoadjuvant treatment of preoperative patients

    The results published today also re-emphasize the importance of improving NSCLC screening and early detection, and patients discussing treatment options with their treating physicians necessity


    Nivolumab involves the following warnings and precautions: Serious and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis or hepatotoxicity, endocrinopathy, cutaneous adverse reactions, nephritis with renal insufficiency, and other immune-mediated adverse reactions adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; Mortality is increased, so use outside of controlled clinical trials is not recommended

    Adam Lenkowsky, senior vice president and general manager of Bristol-Myers Squibb's U.
    Cardiovascular, Immunology and Oncology business unit, said: "At Bristol-Myers Squibb, we have been leading the scientific innovation of immunotherapy in the treatment of early stage cancer and are committed to providing patients with Bringing new treatment options

    Today's approval is a good example of our commitment to expanding the use of nivolumab-based regimens in non-small cell lung cancer, the most common form of lung cancer , which is expected to allow patients to benefit from the disease at an early stage


    The application was approved under the FDA's Real-Time Oncology Review (RTOR) pilot program, which is designed to ensure safe and effective treatment for patients as early as possible
    The review is also based on the FDA's Orbis program, which enables simultaneous reviews by health regulators in Australia, Canada and the United Kingdom, which are currently ongoing

    Event-free survival data from the Phase III clinical study CheckMate-816 will be presented at the 2022 American Association for Cancer Research (AACR) annual meeting in April


    (This indication has not yet been approved in China
    The information contained in this document is for reference only, please follow the advice or guidance of doctors or other medical and health professionals)

    About CheckMate -816

    CheckMate -816 is a global randomized, open-label Phase III clinical study to evaluate the neoadjuvant treatment of nivolumab in combination with platinum-based doublet chemotherapy compared with chemotherapy alone in adult patients with resectable non-small cell lung cancer efficacy, regardless of PD-L1 expression levels
    The main inclusion criteria for the trial were: histologically confirmed stage IB (≥4 cm), stage II, or stage IIIA (according to the 7th edition of the AJCC/UICC staging criteria), ECOG performance status score of 0 or 1, and measurable disease (RECIST 1.
    1) non-small cell lung cancer patients

    Patients with unresectable or metastatic non-small cell lung cancer, known EGFR gene mutation or ALK gene translocation, peripheral neuropathy grade 2 or higher, active autoimmune disease, or requiring systemic immunosuppressive therapy were excluded outside of research

    In the primary analysis, 358 patients were randomized preoperatively to receive nivolumab (360 mg) in combination with same-day platinum-containing doublet chemotherapy based on histological type (every 3 weeks for 3 cycles), or nivolumab (360 mg) alone Platinum doublet chemotherapy (3 cycles every 3 weeks) followed by surgery


    The primary endpoints of the study were event-free survival as determined by blinded independent central review (BICR) and pathological complete response rate as determined by blinded independent pathological review (BIPR)
    Event-free survival was defined as the length of time from randomization to the occurrence of any of the following events: disease progression leading to inoperability, disease progression or recurrence after surgery, or death from any cause

    Pathological complete response was defined as 0% residual viable tumor cells in both the primary tumor and sampled lymph nodes as assessed by BIPR

    Another efficacy outcome measure was overall survival


    About Lung Cancer

    Lung cancer is the leading cause of cancer death worldwide
    Non-small cell lung cancer and small cell lung cancer are the two main types of lung cancer, with non-small cell lung cancer being the most common, accounting for 84% of all diagnosed cases

    Surgery (resection) remains the standard of care for patients with resectable NSCLC

    Even in patients with non-small cell lung cancer treated with surgery, 30% to 55% of patients will relapse and die of the disease after surgery


    Source: Bristol-Myers Squibb

    The original is abridged

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