Neoadjuvant treatment with nivolumab is feasible and safe for patients with early stage resectable non-small cell lung cancer (NSCLC), according to the first report of a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1

Nivolumab is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic NSCLC and progression on or after platinum-based chemotherapy. Researchers evaluated the activity and tolerability of PD-1 blockade with nivolumab among patients with early stage NSCLC in the neoadjuvant setting.

For the open-label, phase 2 study ( Identifier: NCT02259621), researchers enrolled 18 patients with untreated, resectable, stage I-IIIA NSCLC. After undergoing pretreatment tumor biopsy, all patients received 2 doses of nivolumab at 4 and 2 weeks prior to planned surgical resection. Adjuvant chemotherapy was administered at investigator’s discretion.

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Of the 18 patients, 16 completed surgical resection with no delays to surgery or surgical complications due to nivolumab therapy.

Results showed that 80% of 15 resected patients had pathologic evidence of tumor regression and 40% achieved major pathologic responses, with the final pathology report pending for the sixteenth patient.

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Three of the 6 patients with major pathologic response had no radiographic evidence of response, and 3 of 4 tested were positive for PD-L1 overexpression.

The findings suggest that neoadjuvant treatment with anti-PD1 immunotherapy may have significant activity among patients with early stage NSCLC.                              


  1. Forde PM, Smith KN, Chaft JE, et al. Neoadjuvant anti-PD1, nivolumab, in early stage resectable non-small cell lung cancer. Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.