The study found that adding perioperative immunotherapy to pre-surgical chemotherapy greatly improved event-free survival in patients with resectable early-stage non-small cell lung cancer (NSCLC), compared to using chemotherapy alone. This treatment was given before and after surgery and was found to be beneficial for patients. The research was conducted by The University of Texas MD Anderson Cancer Center.
The Phase III CheckMate 77T study results were released today in the New England Journal of Medicine. After 25.4 months, patients who received perioperative nivolumab had not yet reached the median EFS, while those who only had chemotherapy had a median EFS of 18.4 months. This means the perioperative combination significantly prolonged EFS compared to the control group. The data, which showed a 42% reduction in the risk of disease progression, recurrence, or death, was initially presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
Patients who were given the perioperative nivolumab-based regimen had higher rates of pathological complete response (pCR) compared to those who only got chemotherapy (25.3% vs. 4.7%). They also had higher rates of major pathological response (MPR) (35.4% vs. 12.1%). This study shows that perioperative nivolumab is an effective approach in reducing the risk compared to the standard-of-care neoadjuvant chemoimmunotherapy treatment.Principal investigator Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head & Neck Medical Oncology, stated that the study found evidence to suggest that perioperative immunotherapy could help patients with operable lung cancer live longer without the cancer recurring. Around 30% of NSCLC patients have operable disease, which means their tumor can be removed with surgery. However, more than half of these patients will experience cancer recurrence without additional therapy. Chemotherapy given before or after surgery has not been effective in preventing lung cancer relapse.
The CheckMate 77T trial, a randomized and double-blind study that started in 2019, involved over 450 NSCLC patients aged 18 and above from various locations. Participants were randomly assigned to receive neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, or neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo
The data indicated that the perioperative nivolumab regimen did not show any new safety concerns and was consistent with the known safety profiles of the individual agents. Grade 3-4 treatment-related side effects were observed in 32% and 25% of pat.Clients who received the perioperative combination or control therapy experienced surgery-related adverse events at a rate of 12% in both treatment arms. These results build upon the recent success of neoadjuvant nivolumab plus chemotherapy in NSCLC. The Phase III CheckMate 816 study, which took place in March 2022, led to FDA approval of nivolumab combined with platinum-based chemotherapy. “I am excited about the initial findings of the study,” Cascone stated. “In the future, it will be crucial to identify patient and disease characteristics that will help us determine who can potentially be cured with neoadjuvant therapy.”The CheckMate 77T study, sponsored by Bristol Myers Squibb, aimed to identify patients who would benefit from more intensified treatment strategies beyond juvant chemoimmunotherapy. The study concluded that it is important to distinguish between patients who will benefit from juvant chemoimmunotherapy only and those who will require more intensive treatment.
