by A recent study conducted by The University of Texas MD Anderson Cancer Center has revealed that the addition of perioperative immunotherapy to pre-surgical chemotherapy significantly improves event-free survival (EFS) in patients with resectable early-stage non-small cell lung cancer (NSCLC). The findings from the Phase III CheckMate 77T study were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
With a median follow-up of 25.4 months, the study found that patients who received perioperative nivolumab, an immunotherapy drug, experienced significantly prolonged EFS compared to those who only received chemotherapy. The median EFS for patients receiving chemotherapy alone was 18.4 months, while the median had not yet been reached for patients receiving perioperative nivolumab. This translates to a 42% reduction in the risk of disease progression, recurrence, or death for patients treated with the perioperative combination.
Furthermore, patients who received the perioperative nivolumab-based regimen also demonstrated higher rates of pathological complete response (pCR) and major pathological response (MPR) compared to those who received chemotherapy alone. The study showed that 25.3% of patients in the immunotherapy group achieved a pCR, meaning no tumor remained at surgery, compared to only 4.7% in the chemotherapy group. Additionally, 35.4% of patients in the immunotherapy group achieved an MPR, with less than or equal to 10% of viable tumor cells remaining at the time of surgery, compared to 12.1% in the chemotherapy group.
Resectable early-stage NSCLC refers to patients whose tumors can be removed through surgical intervention. While surgery can potentially cure these patients, more than half of them experience cancer recurrence without additional treatment. Current standard therapies, such as chemotherapy given before or after surgery, offer minimal survival benefits. Therefore, the promising results of the CheckMate 77T study suggest that the addition of perioperative immunotherapy could significantly improve outcomes for this patient population.
The randomized, double-blind trial, which commenced in 2019, included over 450 NSCLC patients from various countries. Participants were randomly assigned to receive either neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, or neoadjuvant chemotherapy and a placebo followed by surgery and a placebo.
The study also assessed the safety of the perioperative nivolumab regimen and found no new safety concerns. The observed side effects were consistent with the known safety profiles of the individual agents. Grade 3-4 treatment-related side effects were observed in 32% and 25% of patients receiving the perioperative combination or control therapy, respectively. Surgery-related adverse events were reported in 12% of patients in both treatment arms.
These findings build on the success of previous studies that demonstrated the efficacy of neoadjuvant nivolumab combined with chemotherapy in NSCLC. In fact, the Phase III CheckMate 816 study, conducted in March 2022, led to the approval of the nivolumab and platinum-based chemotherapy combination by the U.S. Food and Drug Administration (FDA).
Dr. Bonnie Glisson, a researcher involved in the study, expressed enthusiasm for the initial findings and emphasized the need to identify patient and disease characteristics that will help determine the suitability of neoadjuvant immunotherapy as a standalone treatment or the need for more intensive treatment strategies. The researchers remain optimistic about the potential of perioperative immunotherapy to improve outcomes for patients with resectable early-stage lung cancer.
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- Source: Coherent Market Insights, Public sources, Desk research
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