A Phase III study from The University of Texas MD Anderson Cancer Center has revealed that combining perioperative immunotherapy with chemotherapy significantly improves outcomes for patients with resectable early-stage non-small cell lung cancer (NSCLC).
The research, published in the New England Journal of Medicine, demonstrates that administering nivolumab both before and after surgery enhances event-free survival (EFS) compared to chemotherapy alone.
The CheckMate 77T trial, which began in 2019, included over 450 NSCLC patients from around the world. Participants were randomized to receive either neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, or neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
At a median follow-up of 25.4 months, the median EFS for the chemotherapy-only group was 18.4 months. In contrast, the median EFS for those receiving the perioperative nivolumab combination had not yet been reached, indicating a significant extension in survival without disease progression, recurrence, or death. This translates to a 42 percent reduction in risk for those receiving the immunotherapy regimen.
The study also reported significantly higher rates of pathological complete response (pCR) and major pathological response (MPR) among patients treated with perioperative nivolumab. Specifically, 25.3 percent of these patients had no tumor remaining at surgery (pCR), compared to just 4.7 percent in the chemotherapy-only group. Additionally, 35.4 percent of patients receiving the immunotherapy combination had 10 percent or less viable tumor cells at surgery (MPR), compared to 12.1 percent in the control group.
“These findings support perioperative nivolumab as an effective approach that reduces the risk of lung cancer relapse,” said Tina Cascone, the principal investigator and associate professor of Thoracic/Head & Neck Medical Oncology at MD Anderson. “This study builds on the standard-of-care neoadjuvant chemoimmunotherapy treatment and gives patients with operable lung cancer an opportunity to live longer without their cancer returning.”
Approximately 30 percent of patients diagnosed with NSCLC have tumors that can be surgically removed. While surgery can potentially cure many of these patients, more than half will experience cancer recurrence without additional therapy. Historically, chemotherapy administered before or after surgery has offered only a minimal survival benefit.
The randomized, double-blind trial showed no new safety concerns with the perioperative nivolumab regimen. Grade 3-4 treatment-related side effects occurred in 32 percent of patients receiving the immunotherapy combination and 25 percent of those on the control therapy. Surgery-related adverse events were reported in 12 percent of patients in both groups.
This research builds on previous success with neoadjuvant nivolumab plus chemotherapy in NSCLC. The Phase III CheckMate 816 study led to FDA approval of nivolumab combined with platinum-based chemotherapy in March 2022.
Cascone expressed optimism about the findings, stating, “Looking ahead, it will be critical to identify patient and disease characteristics that will tell us who can potentially be cured with neoadjuvant chemoimmunotherapy only and who will benefit from more intensified treatment strategies.”
