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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.
    S.
    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.
    45-0.
    87; P=0.
    0052)

    .
    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.
    0-26.
    7) in the chemotherapy-alone group

    .
    In addition, 24% of patients in the nivolumab-chemotherapy group achieved a pathological complete response (95% CI: 18.
    0-31.
    0) versus 2.
    2% in the chemotherapy-alone group (95% CI: 0.
    6-5.
    6; estimated treatment difference: 21.
    6; 95% CI: 15.
    1-28.
    2; P<0.
    0001)

    .
    A prespecified interim analysis of overall survival showed an HR of 0.
    57 (95% CI: 0.
    38-0.
    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.
    S.
    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

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