Adjuvant nivolumab following neoadjuvant nivolumab plus chemotherapy and surgery may be effective at reducing the risk of disease recurrence or mortality in patients with resectable non–small cell lung cancer (NSCLC) compared with neoadjuvant nivolumab plus chemotherapy alone, according to new findings presented by Forde et al at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (Abstract PL02.08).
Background
The phase III CheckMate 816 trial evaluated neoadjuvant nivolumab plus chemotherapy in patients with NSCLC. Researchers demonstrated statistically significant and clinically meaningful improvements in event-free survival and the pathologic complete response rate.
Building on this foundation, researchers initiated the phase III CheckMate 77T trial, which assessed perioperative nivolumab in patients with NSCLC. The researchers revealed statistically significant and clinically meaningful improvements in event-free survival and a meaningful increase in the pathologic complete response rate compared with control.
Study Methods and Results
In the study, investigators analyzed individual patient-level data from both phase III trials—CheckMate 77T and CheckMate 816—to examine which patients with stage I to III NSCLC may derive benefit from adjuvant nivolumab following neoadjuvant nivolumab plus chemotherapy and surgery.
The new analysis compared event-free survival from the time of surgery among 139 patients involved in the CheckMate 77T trial—who received neoadjuvant nivolumab plus chemotherapy followed by definitive surgery and at least one dose of adjuvant nivolumab—with 147 patients who participated in the CheckMate 816 trial, 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 demonstrated improved event-free survival compared with neoadjuvant nivolumab plus chemotherapy alone. Specifically, the hazard ratios for event-free survival were 0.61 (stabilized average treatment effect for the treated population) and 0.56 (stabilized average treatment effect). Notably, the event-free survival benefit was observed regardless of pathologic complete response status; however, the benefit was clearer in patients without pathologic complete response who received additional adjuvant nivolumab treatment following surgery. Benefit was observed regardless of baseline disease stage, with a greater magnitude of benefit in patients with tumor PD-L1 < 1%.
The investigators reported no new safety signals with perioperative nivolumab.
Conclusions
“The individual patient-level data analysis from [the] CheckMate 77T and CheckMate 816 [trials] indicates that perioperative nivolumab offers a notable improvement in [event-free survival] over neoadjuvant nivolumab plus chemotherapy alone in patients with resectable NSCLC, including those with PD-L1 < 1% expression,” highlighted lead study author Patrick Forde, MD, PhD, of The Bloomberg-Kimmel Institute for Cancer Immunotherapy and the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University.
“While the findings should be considered with caution [because of] the limitations of propensity score weighting, this cross-trial analysis provides compelling evidence supporting perioperative nivolumab as an effective treatment option for resectable NSCLC,” underscored senior study author Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center. “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. 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,” she concluded.
Disclosure: For full disclosures of the study authors, visit cattendee.abstractsonline.com.
