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NEOSTAR Results Indicate that Neoadjuvant Nivolumab Plus Ipilimumab Enhances Pathologic Responses in Operable NSCLC

Phase II randomised study met prespecified primary endpoint threshold in patients with operable non-small cell lung cancer
09 Mar 2021
Non-Small Cell Lung Cancer

Findings from the randomised phase II NEOSTAR study indicate that neoadjuvant treatment with nivolumab plus ipilimumab enhances pathologic responses, tumour immune infiltrates and immunologic memory in patients with operable non-small cell lung cancer (NSCLC). Tina Cascone of the Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center in Houston, TX, USA and colleagues reported the study results on 18 February 2021 in the Nature Medicine.

The authors underlined in the study background that a combination of nivolumab and ipilimumab improves clinical outcomes in metastatic NSCLC. However, efficacy and impact of this combination on the immune microenvironment in patients with operable NSCLC was not clear. It prompted the NEOSTAR investigators to perform the phase II randomised study (NCT03158129) of neoadjuvant nivolumab or nivolumab plus ipilimumab followed by surgery in patients with operable NSCLC.

This study of neoadjuvant nivolumab or nivolumab plus ipilimumab followed by surgery was conducted in 44 patients with operable NSCLC. Major pathologic response (MPR) served as the primary endpoint. The MPR rate for each treatment arm was tested against historical controls of neoadjuvant chemotherapy.

In combination arm treatment with nivolumab plus ipilimumab met the prespecified primary endpoint threshold of 6 MPRs in 21 patients. In particular, the MPR rate was 38% (8 of 21) in the combination arm. The MPR rate was 22% (5 of 23) in the nivolumab arm.

Among 37 patients who undergone resection in this study, the MPR rate was 24% (5 of 21) in nivolumab arm and 50% (8 of 18) in nivolumab plus ipilimumab arm.

Compared with nivolumab, nivolumab plus ipilimumab resulted in higher pathologic complete response rates (10% vs 38%), less viable tumour (median 50% vs 9%), and greater frequencies of effector, tissue-resident memory and effector memory T cells.

Increased abundance of gut Ruminococcus and Akkermansia spp. was associated with MPR to combination therapy with nivolumab plus ipilimumab.

The authors concluded that their findings merit further investigation of neoadjuvant therapy with nivolumab plus ipilimumab in patients with operable NSCLC.


Cascone T, William WN, Weissferdt A, et al. Neoadjuvant nivolumab or nivolumab plus ipilimumab in operable non-small cell lung cancer: the phase 2 randomized NEOSTAR trial. Nature Medicine; Published online 18 February 2021. DOI: https://doi.org/10.1038/s41591-020-01224-2

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