Neoadjuvant nivolumab improves overall survival in resectable NSCLC

The final, 5-year analysis from CheckMate 816 demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of neoadjuvant nivolumab-chemotherapy combination over chemotherapy alone in participants with resectable non-small cell lung cancer (NSCLC).

Previously, results from the phase 3 CheckMate 816 study (NCT02998528) had shown that the addition of nivolumab to neoadjuvant chemotherapy significantly improved both event-free survival and pathological complete response (pCR) in participants with resectable NSCLC without actionable genomic alterations [1]. Prof. Patrick Forde (Trinity St James’s Cancer Institute, Ireland) now presented the 5-year OS data [2].

The CheckMate 816 randomised 358 participants 1:1 to receive 3 cycles of neoadjuvant treatment with nivolumab plus chemotherapy or chemotherapy alone. Optional adjuvant chemotherapy and/or radiotherapy was allowed. The addition of nivolumab to neoadjuvant chemotherapy significantly improved the 5-year OS rate: 65% versus 55% (HR 0.72; 95% CI 0.523–0.998; P=0.0479). The lung cancer-specific survival improved from 65% to 75% and the benefit of nivolumab was observed across all subgroups except participants with a PD-L1-negative tumour (see Figure).

Figure: OS rate by tumour PD-L1 expression in resectable NSCLC treated with nivolumab plus neoadjuvant chemotherapy versus chemotherapy alone [2]



Chemo, chemotherapy; CI, confidence interval; HR, hazard ratio; NIVO, nivolumab; NR, not reached; OS, overall survival; PD-L1, programmed cell death-ligand 1.

An exploratory analysis revealed that the pCR status predicted high 5-year OS rate compared to no pCR (95% vs 56%). In addition, clearance of ctDNA after 3 cycles of neoadjuvant therapy was associated with a better 5-year OS compared to no clearance of ctDNA (75% vs 53%).

Prof. Forde concluded that CheckMate 816 demonstrated a statistically significant OS benefit, affirming a paradigm shift in the treatment of resectable NSCLC without actionable genomic alterations.

In Europe, this combination is approved only for PD-L1-positive NSCLC, and these results clearly demonstrate its high clinical value.

1. Forde PM, et al. N Engl J Med. 2022;386:1973–1985.
2. Forde PM, et al. Overall survival with neoadjuvant nivolumab + chemotherapy in patients with resectable NSCLC in CheckMate 816. Abstract LBA8000, ASCO Annual Meeting 2025, 30 May–3 June, Chicago, IL, USA.

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Posted on 30 July 2025