CheckMate 77T QOL Data Further Support Perioperative Nivolumab in Resectable NSCLC

Perioperative nivolumab (Opdivo) did not negatively impact health-related quality of life (HRQOL) and reduced the risk of deterioration compared with placebo, irrespective of nodal status or surgical outcomes, in patients with stage III N2 or non-N2 non–small cell lung cancer (NSCLC), according to long-term data from the phase 3 CheckMate 77T trial (NCT04025879) presented during a press briefing at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer.¹

The study evaluated HRQOL by nodal status and surgical outcomes by leveraging patient-reported outcome (PRO) measures like the NSCLC-Symptom Assessment Questionnaire (NSCLC-SAQ) and the EQ-5D-3L visual analogue scale (VAS). Findings from the exploratory analysis showed that those with stage III N2 disease had a lower risk of HRQOL deterioration and delayed median time to definitive deterioration (TTDD) with nivolumab vs placebo, including those with simple lobectomy or complete resection based on NSCLC-SAQ total scores (HR, 0.45; 95% CI, 0.26-0.79) and EQ-5D-3L VAS (HR, 0.53; 95% CI, 0.31-0.92).

Specifically, according to the NSCLC-SAQ instrument, the TTDD was 44.5 months in the nivolumab arm (n = 91) vs 31.4 months in the placebo arm (n = 90). The 12-, 24-, and 30-month TTDD rates in the respective arms were 88% and 69%, 77% and 55%, and 77% and 53%. According to the EQ-5D-3L VAS instrument, the median TTDD was 44.5 months with nivolumab and 35.7 months with placebo. In the nivolumab arm, the TTDD rates at 12, 24, and 30 months were 81%, 77%, and 73%; in the placebo arm, these rates were 66%, 53%, and 53%.

“What’s important to note is that both in the N2 and non-N2 patients, if you look at departure of baseline QOL, other than the brief period after surgery, most patients remain within the nonclinically significant range, indicating that perioperative nivolumab did not harm these patients,” Jonathan D. Spicer, MD, PhD, medical director of the Thoracic Oncology Program at McGill University Health Centre, in Montreal, Quebec, said in the briefing. “In fact, it provided benefit in a significant majority of them, and this is durable throughout the course of observation.”

CheckMate-77T: What Is the Significance of the Trial, and What Prior Data Have Read Out?

The randomized, global, phase 3 study showed that perioperative nivolumab led to a statistically significant and clinically meaningful event-free survival (EFS) benefit and an improved pathologic complete response (pCR) rate vs placebo plus chemotherapy in patients with resectable NSCLC.² The median EFS was not reached (NR; 95% CI, 28.9-not estimable) in the nivolumab arm vs 18.4 months (95% CI, 13.6-28.1) in the placebo arm (HR, 0.58; 95% CI, 0.43-0.78; P = .00025).³

The data supported the October 2024 FDA approval of nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment followed by nivolumab monotherapy after surgery as adjuvant treatment for adults with resectable NSCLC without EGFR mutations or ALK rearrangements.

In a past interview with OncLive®, Mark Awad, MD, PhD, of Memorial Sloan Kettering Cancer Center, in New York, NY, discussed the significance of the trial and the approval:⁴ “What CheckMate 77T and other [trials] are beginning to show is that using chemotherapy and immunotherapy before surgery, and immunotherapy after surgery, significantly reduces the risk of recurrence. As patients are followed more longitudinally in these trials, we’re seeing a clear separation in terms of how often the cancer tends to come back, depending on whether patients were randomly assigned to the arm of the trial that included immunotherapy, or to the placebo arm of the trial, where patients only received chemotherapy before surgery but did not receive immunotherapy before or after surgery. This is an exciting development in early-stage lung cancer.”

Findings shared during the 2024 ASCO Annual Meeting showed that clinical benefit was observed with perioperative nivolumab vs placebo in those with stage III N2 NSCLC, at a median EFS of 30.2 months (95% CI, 26.9-not reached) vs 10.0 months (95% CI, 8.1-15.1; HR, 0.46; 95% CI, 0.30-0.70).⁵ The pCR rates in the respective arms were 22.0% and 5.6% (difference, 16.4%). These benefits were also observed in those with single- (HR, 0.49; 95% CI, 0.29-0.84) or multistation (HR, 0.43; 95% CI, 0.21-0.88) N2 NSCLC, and those with stage III non-N2 NSCLC (HR, 0.60; 95% CI, 0.33-1.08).

What Else Was Learned From the Current QOL Analysis?

HRQOL was evaluated per mean changes from baseline NSCLC-SAQ or EQ-5D-3L VAS scores was maintained among patients with stage III N2 NSCLC who had simple lobectomy or complete resection.¹

Specifically, per the NSCLC-SAQ instrument, the median TTDD was NR in those who received nivolumab and had a simple lobectomy (n = 58) vs 36.0 months in those who received placebo (n = 49; HR, 0.41; 95% CI, 0.21-0.82). By the EQ-5D-3L VAS instrument, those who received nivolumab and had a simple lobectomy experienced a median TTDD of 50.8 months vs 3.57 months with placebo (HR, 0.35; 95% CI, 0.17-0.69). By the NSCLC-SAQ instrument, the median TTDD was 44.5 months in those who received nivolumab and achieved complete resection (n = 60) vs 36.0 months with placebo (n = 57; HR, 0.48; 95% CI, 0.24-0.93). By the EQ-5D-3L VAS instrument, the median TTDD was 50.8 months with nivolumab vs NR with placebo (HR, 0.37; 95% CI, 0.18-0.76).

“Looking at the impact of surgical outcomes, specifically the extent of resection and the completeness of resection, we see benefits in terms of TTDD for patients who had a simple lobectomy, as well as those with complete resection; this was true both on the symptom assessment and visual analog scales,” Spicer explained. “The number of patients with R+ resections or extended lobectomies was few, and therefore, we cannot generate curves to represent those patients.”

He concluded by saying that these findings further support perioperative nivolumab as an efficacious treatment option in eligible patients with resectable NSCLC, including those with stage III N2 disease.

Editor’s Note: No disclosures were listed.

References

1. Spicer JD, Pulla MP, Cascone T, et al. Patient-reported outcomes with perioperative nivolumab by nodal status in patients with resectable NSCLC from CheckMate 77T. Presented at: International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract 3005.
2. Cascone T, Award MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med. 2024;390(19):1756-1769. doi:10.1056/NEJM0a2311926
3. FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer. FDA. October 3, 2024. Accessed September 6, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-nivolumab-resectable-non-small-cell-lung-cancer
4. Wahner A. Perioperative nivolumab plus chemotherapy represents the future of personalized NSCLC care. November 14, 2024. Access September 6, 2025. https://www.onclive.com/view/perioperative-nivolumab-plus-chemotherapy-represents-the-future-of-personalized-nsclc-care
5. Provencio M, Awad MM, Spicer J, et al. Clinical outcomes with perioperative nivolumab (NIVO) by nodal status among patients (pts) with stage III resectable NSCLC: Results from the phase 3 CheckMate 77T study. J Clin Oncol. 2024;42(suppl 17):LBA8007. doi:10.1200/JCO.2024.42.17_suppl.LBA8007