Compared with neoadjuvant chemotherapy alone, adding perioperative immunotherapy—given before and after surgery—significantly improved event-free survival in patients with resectable early-stage non–small cell lung cancer (NSCLC). Results from the phase III CheckMate 77T study were presented at the European Society for Medical Oncology (ESMO) Congress 2023 by Tina Cascone, MD, PhD, and colleagues (Abstract LBA1).
At a median follow-up of 25.4 months, the median event-free survival with chemotherapy alone was 18.4 months, whereas the median had not yet been reached for patients receiving perioperative nivolumab—meaning event-free survival was prolonged significantly over the control group. These results correspond to a 42% reduction in risk of disease progression, recurrence, or death for those receiving the perioperative combination.
Patients who received the perioperative nivolumab-based regimen also saw significantly higher rates of pathologic complete response (defined as no tumor remaining at surgery) compared with those who received chemotherapy alone (25.3% vs. 4.7%). Rates of major pathologic response (≤ 10% of viable tumor cells remaining at time of surgery) were also higher in patients who received perioperative immunotherapy (35.4% vs. 12.1%).
Tina Cascone, MD, PhD
“This study builds on the standard-of-care neoadjuvant treatment and supports perioperative nivolumab as an effective approach that reduces the risk of lung cancer relapse,” said principal investigator Dr. Cascone, Associate Professor of Thoracic/Head & Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “These findings add to evidence that the perioperative immunotherapy path gives patients with operable lung cancer an opportunity to live longer without their cancer returning.”
Roughly 30% of patients diagnosed with NSCLC have operable disease. Although many of these patients potentially can be cured by surgery, more than half will experience cancer recurrence without additional therapy. Chemotherapy given either before or after surgery provides only a minimal survival benefit.
More Details on CheckMate 77T
The randomized, double-blind CheckMate 77T trial, which began in 2019, included more than 450 patients with NSCLC over the age of 18 from around the globe. Participants were randomly assigned to receive treatment with either neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, or neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
The data showed no new safety signals with the perioperative nivolumab regimen and is consistent with known safety profiles of the individual agents. Grade 3 or 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 occurred in 12% of patients in both treatment arms.
These findings add to recent success seen with neoadjuvant nivolumab plus chemotherapy in NSCLC. In March 2022, the phase III CheckMate 816 study led to the U.S. Food and Drug Administration approval of nivolumab combined with platinum-based chemotherapy.
“I am enthusiastic about the initial findings of the study,” Dr. Cascone said. “Looking ahead, it will be critical to identify patient and disease characteristics that will tell us who can potentially be cured with neoadjuvant immunotherapy only and who will benefit from more intensified treatment strategies.”
Disclosure: The CheckMate 77T study was sponsored by Bristol Myers Squibb. For full disclosures of the study authors, visit cslide.ctimeetingtech.com/esmo2023.
