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Nivolumab shows promise in early-stage resectable NSCLC



Neoadjuvant nivolumab did not delay surgery and produced at least 90% tumor regression in nearly half of early-stage, resectable non–small cell lung cancers (NSCLC), according to the results of a 21-patient pilot trial.

Eighty percent of patients were alive and recurrence-free a year after surgery, said Patrick M. Forde, MBBCh, and his colleagues from Johns Hopkins University, Baltimore. The only grade 3 or higher adverse event was treatment-related pneumonia, which did not prevent surgery. The findings were reported at the annual meeting of the American Association for Cancer Research and simultaneously in the New England Journal of Medicine.

lung cancer ©Sebastian Kaulitzki/Thinkstock
Nivolumab targets the programmed cell death 1 (PD-1) pathway and is approved in several tumor types, including advanced NSCLC that has progressed despite platinum-based or epidermal growth factor receptor or anaplastic lymphoma kinase–targeted therapy. That approval was based on the CHECKMATE-057 trial, in which nivolumab significantly outperformed docetaxel in metastatic NSCLC (median overall survival, 12.2 vs. 9.4 months; P = .002). However, programmed cell death 1 inhibition in resectable NSCLC remained unexplored, Dr. Forde and his colleagues noted.

For the study (NCT02259621), 21 patients with treatment-naive, stage I, II, or III NSCLC received two preoperative doses of nivolumab (3 mg/kg) 2 weeks apart, with surgery timed for 4 weeks after the first dose. In all, 62% of patients had adenocarcinoma, 81% had stage II or IIIa disease, and 86% were current or former smokers. Patients were followed for a median of 12 months after surgery (range, 0.8-19.7 months), and the researchers assessed safety, tumor response, programmed death ligand 1 mutational burden, and T-cell response.

Among 20 patients with evaluable resected primary tumors, nine (45%) showed a major pathologic response, defined as having 10% or fewer residual viable tumor cells. Twelve-month, recurrence-free survival was 83% (95% confidence interval, 66%-100%). The three progressors included one patient with 75% residual tumor at resection who subsequently developed a brain lesion, a patient with 5% residual tumor at resection who developed mediastinal lymph node recurrence, and a patient with 80% residual tumor at resection. The first two patients had durable responses to stereotactic radiotherapy or chemoradiotherapy, while the third patient developed fatal distal metastatic disease.


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