CheckMate 77T: Perioperative Nivolumab Shows Long-Term EFS and ‘Favorable’ OS Trend in Resectable NSCLC

Perioperative nivolumab “continued to demonstrate long-term” event-free survival (EFS) with a “favorable trend” in overall survival (OS) compared with placebo for patients with resectable non–small cell lung cancer (NSCLC), according to CheckMate 77T results presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Mariano Provencio, MD, PhD, of the Hospital Universitario Puerta de Hierro, Madrid, Spain, presented the results as a late-breaking abstract at the meeting.

“In this updated analysis, perioperative nivolumab continued to demonstrate event-free survival benefits versus placebo in patients with resectable non–small cell lung cancer,” Dr. Provencio said as he introduced his presentation. “CtDNA [circulating tumor DNA] clearance and pCR [pathologic complete response] were associated with improved EFS regardless of treatment.”

The phase 3 study previously demonstrated a “statistically significant and clinically meaningful improvement” in EFS with perioperative nivolumab versus placebo in patients with resectable NSCLC. In addition, pCR rates “were also improved.”

At the 2025 ASCO Annual Meeting, Dr. Provencio reported updated EFS and OS from the first prespecified interim analysis of CheckMate 77T, along with exploratory biomarker analyses.

Study investigators randomized patients with resectable stage IIA to IIIB NSCLC 1:1 to receive one of two treatment regimens:

• Neoadjuvant nivolumab plus chemotherapy every 3 weeks for up to four cycles, followed by adjuvant nivolumab every 4 weeks for up to 13 cycles
• Neoadjuvant placebo plus chemotherapy every 3 weeks for up to four cycles, followed by adjuvant placebo every 4 weeks for up to 13 cycles

The primary end point was EFS as assessed by blinded independent central review, with secondary end points including pCR, OS, and safety. The exploratory analyses evaluated treatment efficacy by pCR status, presurgery ctDNA clearance, and tumor genomic alterations.

With a median follow-up of 41 months, nivolumab “continued to provide an EFS benefit” compared with placebo in all randomized patients, “regardless of disease stage, tumor histology, or PD-L1 expression,” showing a hazard ratio (HR) of 0.61 (95% CI, 0.46-0.80). The 30-month EFS rate was 61% for those receiving nivolumab, compared with 43% for those receiving placebo.

In addition, among the patients who were biomarker-evaluable, those who had ctDNA clearance had greater EFS compared with those who did not, showing an HR of 0.41 among those receiving nivolumab and an HR of 0.62 among those receiving placebo.

At the first prespecified interim OS analysis, nivolumab showed a “trend of OS improvement” versus placebo for all randomized patients, showing an HR of 0.85. The median OS was not reached in either treatment arm, with 30-month OS rates of 78% with nivolumab and 72% with placebo.

This update showed that perioperative nivolumab “continued to show long-term EFS benefit” and a “favorable OS trend” compared with placebo for patients with resectable NSCLC without any new safety signals, the study authors concluded, noting that in exploratory analyses, presurgery ctDNA clearance “was associated with EFS benefit” and that EFS “favored” nivolumab “regardless of KRAS, STK11, or KEAP1 mutation status.”