Perioperative Nivolumab in Resectable Lung Cancer

Tina Cascone*, Mark M. Awad, Jonathan D. Spicer, CheckMate 77T Investigators, Jie He, Shun Lu, Boris Sepesi, Fumihiro Tanaka, Janis M. Taube, Robin Cornelissen, Libor Havel, Nina Karaseva, Jaroslaw Kuzdzal, Lubos B. Petruzelka, Lin Wu, Jean Louis Pujol, Hiroyuki Ito, Tudor Eliade Ciuleanu, Ludmila De Oliveira Muniz Koch, Annelies JanssensAurelia Alexandru, Sabine Bohnet, Fedor V. Moiseyenko, Yang Gao, Yasutaka Watanabe, Cinthya Coronado Erdmann, Padma Sathyanarayana, Stephanie Meadows-Shropshire, Steven I. Blum, Mariano Provencio Pulla

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)

Abstract

Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable non-small-cell lung cancer (NSCLC). Perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes. METHODS In this phase 3, randomized, double-blind trial, we assigned adults with resectable stage IIA to IIIB NSCLC to receive neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary outcome was event-free survival according to blinded independent review. Secondary outcomes were pathological complete response and major pathological response ac¬cording to blinded independent review, overall survival, and safety. RESULTS At this prespecified interim analysis (median follow-up, 25.4 months), the percent¬age of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (hazard ratio for disease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% confidence interval [CI], 0.42 to 0.81; P<0.001). A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4.01; 95% CI, 2.48 to 6.49). Grade 3 or 4 treatment-related adverse events occurred in 32.5% of the patients in the nivolumab group and in 25.2% of those in the chemotherapy group. CONCLUSIONS Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. No new safety signals were observed. (Funded by Bristol Myers Squibb; CheckMate 77T ClinicalTrials.gov number, NCT04025879.).

Original languageEnglish
Pages (from-to)1756-1769
Number of pages14
JournalNew England Journal of Medicine
Volume390
Issue number19
DOIs
Publication statusPublished - 15 May 2024

Bibliographical note

Publisher Copyright:
© 2024 Massachussetts Medical Society. All rights reserved.

Fingerprint

Dive into the research topics of 'Perioperative Nivolumab in Resectable Lung Cancer'. Together they form a unique fingerprint.

Cite this