New data from landmark analysis presented today report a decreased risk of disease recurrence or death in patients with resectable NSCLC who received adjuvant nivolumab following neoadjuvant nivolumab plus chemotherapy and surgery compared to those who received only neoadjuvant nivolumab plus chemotherapy.

The data was reported at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer.

This is the first analysis of individual patient-level data from two phase 3 trials, CheckMate 77T and CheckMate 816, to examine which patients may derive benefit from adjuvant nivolumab following neoadjuvant nivolumab plus chemotherapy and surgery for stage I-III NSCLC.  

CheckMate 816, which was led by Dr. Patrick Forde of The Bloomberg-Kimmel Institute for Cancer Immunotherapy, The Sidney Kimmel Comprehensive Cancer, in Baltimore, MD. evaluated neoadjuvant nivolumab plus chemotherapy.

The study demonstrated statistically significant and clinically meaningful improvements in event-free survival and pathological complete response and is the sole approved, neoadjuvant only immunotherapy-based treatment for resectable NSCLC.

Building on this foundation, Dr. Tina Cascone of the MD Anderson Cancer Center, in Houston, and her collaborators developed CheckMate 77T, which assessed perioperative nivolumab, revealing statistically significant and clinically meaningful improvement in event-free survival and a meaningful increase in pathological complete response rate compared to control.

This analysis compared event-free survival from the time of surgery among patients from CheckMate 77T, who received neoadjuvant nivolumab plus chemotherapy followed by definitive surgery and at least one dose of adjuvant nivolumab, with patients from CheckMate 816, who also received neoadjuvant nivolumab plus chemotherapy followed by definitive surgery but without adjuvant nivolumab.

After applying propensity score weights to account for differences in baseline characteristics, perioperative nivolumab (N=139) showed improved event-free survival compared to neoadjuvant nivolumab plus chemotherapy only (N=147).

Specifically, the hazard ratios for EFS were 0.61 (weighted ATE) and 0.56 (weighted ATT). Of note, EFS benefit was observed regardless of pCR status although the benefit was clearer in patients without pCR who received additional adjuvant nivolumab treatment after surgery.

Benefit was seen regardless of baseline disease stage, with a greater magnitude of benefit in patients with tumor PD-L1 <1%.   No new safety signals were seen with perioperative nivolumab.

“The individual patient-level data analysis from CheckMate 77T and CheckMate 816 indicates that perioperative nivolumab offers a notable improvement in EFS over neoadjuvant nivolumab plus chemotherapy alone in patients with resectable NSCLC, including those with PD-L1 <1% expression,” reported Dr. Forde.

“While the findings should be considered with caution due to the limitations of propensity score weighting, this cross-trial analysis provides compelling evidence supporting perioperative nivolumab as an effective treatment option for resectable NSCLC.” Dr. Cascone added

“This is the first individual patient-level analysis demonstrating improved efficacy of perioperative nivolumab compared with the standard of care neoadjuvant only nivolumab plus chemotherapy in resectable NSCLC.” She continued,

“These results should be interpreted with caution given the exploratory nature of the analysis. Nevertheless, the findings are very encouraging and provide a foundation for thoughtful discussions with our patients regarding treatment options for their disease.”

Source: International Association for the Study of Lung Cancer