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    Home > Active Ingredient News > Antitumor Therapy > The first phase III clinical study of immune neoadjuvant CheckMate -816 results released: Nivolumab combined with chemotherapy can significantly improve the pCR of lung cancer patients

    The first phase III clinical study of immune neoadjuvant CheckMate -816 results released: Nivolumab combined with chemotherapy can significantly improve the pCR of lung cancer patients

    • Last Update: 2021-04-18
    • Source: Internet
    • Author: User
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    ● Among the patients who received Odivo combined with chemotherapy before surgery, nearly 1/4 of the patients did not find tumor cells in the surgically removed specimens, and this proportion was only 2.
    2% of the patients who received chemotherapy alone.

    ● The Odivo-based treatment program has achieved positive results in phase III clinical studies of four types of early cancers, including non-small cell lung cancer, esophageal cancer/gastroesophageal junction cancer, bladder cancer and melanoma.

    ● The research results will be published as an oral report at the 2021 American Association for Cancer Research (AACR) Annual Conference Clinical Research Plenary.

    On April 10, 2021, Bristol-Myers Squibb (NYSE: BMY) announced the clinical study data of CheckMate -816.

    The results showed that compared with chemotherapy alone, patients with stage Ib to IIIa resectable non-small cell lung cancer who received 3 cycles of Odivo combined chemotherapy treatment before surgery can significantly improve tumor pathological complete remission (pCR) and achieve major Study endpoint.

    In this study, pCR was defined as: after blinded independent pathological review, no cancer cells were found in surgically resected specimens.
    24% of patients who received Odivo’s combined chemotherapy treatment before surgery achieved pCR, while chemotherapy alone Of the patients, this proportion is only 2.
    2%.

    (Odds ratio [OR] 13.
    94, 99% confidence interval [CI]: 3.
    49-55.
    75; p<0.
    0001).

    In addition, Odivo combined with chemotherapy is well tolerated, regardless of the patient's PD-L1 expression level, tumor type or disease stage, the pCR is improved.

    CheckMate -816 is the first randomized, phase III clinical study to prove that neoadjuvant immune combination therapy can bring significant improvement to the pathological complete remission of patients with resectable non-small cell lung cancer.

    The data of the research results will be released for the first time in the form of an oral report (abstract number #5218) at the clinical research plenary meeting of the American Association for Cancer Research (AACR) on April 11, 2021, 00:30-00:45, Beijing time.
    .

    Professor Nicolas Girard, Director of the Medical Oncology Department of the Curie Institute of France, said: “The ultimate goal of early cancer treatment is to prevent the recurrence of the disease and at the same time strive to find a cure for the patient.

    Unfortunately, even after surgery, more than half of the available The disease in patients with non-small cell lung cancer will relapse and die.

    CheckMate-816 pathological complete remission data provides us with early evidence that Odivo combined with chemotherapy as a neoadjuvant treatment for non-small cell lung cancer is expected to bring patients to the potential benefits.

    we hope that these encouraging results ultimately prolong event-free survival of patients (EFS), and, ultimately, overall survival (OS).

    "Oudi Wo same combination chemotherapy in key secondary endpoints Improvement, including major pathological remission (MPR).

    The results of the study showed that in patients who received Odivo combined with chemotherapy before surgery, the main pathological remission rate was 4 times that of patients with chemotherapy alone (36.
    9% vs 8.
    9%; odds ratio [OR] 5.
    70, 99% confidence interval [CI] : 3.
    16-10.
    26), which means that the proportion of tumor cells in the surgically removed specimen is reduced to 10% or less after the patient receives neoadjuvant combination therapy.

    Three cycles of Odivo combined with chemotherapy is safe, and no new safety signals have been observed.

    In the Odivo combined chemotherapy group and the chemotherapy alone group, the incidence of grade 3-4 treatment-related adverse events was 34% and 37%, respectively.

    Few patients canceled surgery due to adverse events, and only two patients in each group experienced such conditions.

    In addition, compared with chemotherapy alone, more patients in this study who used Odivo combined with chemotherapy as neoadjuvant treatment underwent surgery (83% vs 75%), which indicates that Odivo combined with chemotherapy did not reduce the cost of surgery.
    possibility. At the same time, the proportion of patients who achieved complete tumor resection (R0) in the Odivo combined chemotherapy group was more than that in the chemotherapy alone group (83% vs.
    78%).

    The incidence of surgery-related adverse events was similar between the two treatment groups.

    Dr.
    Abderrahim Oukessou, Vice President of Bristol-Myers Squibb and Head of Thoracic Tumor Development, said: “Odivo-based combination therapy has proven to continuously improve the survival of patients with advanced breast tumors.

    Today, CheckMate-816 data shows that In the early stage of non-small cell lung cancer, Odivo combined with chemotherapy is expected to improve the clinical outcome of patients in the long run.
    The
    existing results of the CheckMate-816 study further confirm that tumor immunotherapy is expected to become an important treatment method for doctors in patients who have not yet developed metastasis.
    In resectable tumors, four phase III clinical studies based on Odivo have achieved positive results.

    We sincerely thank the patients and researchers who participated in CheckMate-816, and look forward to seeing Odivo’s combined chemotherapy in Improving another primary endpoint of the study, the potential for event-free survival (EFS).

    At present, this part of the data is still blinded.

    "In the broader field of early-stage non-small cell lung cancer, Bristol-Myers Squibb and partners are working together Explore the use of immunotherapy in neoadjuvant, adjuvant or perioperative period, as well as the combination with concurrent radiotherapy and chemotherapy.

    The use of tumor immunotherapy in neoadjuvant therapy has a double scientific basis: on the one hand, it is expected to seize the earliest opportunity to treat cancer cells that have spread in the body without being discovered.

    On the other hand, when using tumor immunotherapy, the presence of tumors may make the immune response stronger, which is expected to make the treatment more effective.

    About CheckMate-816 Checkmate-816 is a randomized, open-label, multi-center phase III clinical study designed to evaluate the efficacy of Odivo combined with chemotherapy for neoadjuvant therapy in patients with non-small cell lung cancer that can be cut compared with chemotherapy alone .

    In the main analysis, 358 patients were randomized to receive Odivo (360 mg) combined with platinum-based dual-agent chemotherapy based on histological classification (every 3 weeks, up to 3 cycles), or platinum-containing dual-agent alone Chemotherapy (once every 3 weeks, up to 3 cycles).

    The primary study endpoints are pathological complete remission (pCR) and event-free survival (EFS).
    Key secondary endpoints include overall survival (OS), major pathological remission (MPR), and time to death or distant metastasis.

    About Lung Cancer Lung cancer is the leading cause of cancer deaths worldwide.

    Non-small cell lung cancer and small cell lung cancer are the two main types of lung cancer.
    Among them, non-small cell lung cancer (NSCLC) is the most common, accounting for 84% of all confirmed cases.

    Most NSCLC patients (about 60%) have not yet metastasized at the time of diagnosis.

    Although many patients with non-metastatic non-small cell lung cancer have undergone surgery, 30% to 55% of patients will relapse and die of the disease after surgery.

    Therefore, a variety of treatment options are needed, including preoperative (neo-adjuvant therapy) and/or post-operative (adjuvant therapy) to improve the long-term survival of patients.

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