Nivolumab, a fully human anti–PD-1 antibody, restores the function of existing antitumor T cells and has shown a survival benefit in patients with metastatic non–small-cell lung cancer (NSCLC); now a new study published on The New England Journal of Medicine shows that neoadjuvant nivolumab plus chemotherapy increases event-free survival and the percentage of patients with pathological complete response in resectable NSCLC.
Almost one in four patients with a diagnosis of NSCLC has a resectable disease, however 30 to 55% of patients who undergo surgery have recurrency of the disease. Neoadjuvant chemotherapy can be used for the treatment of patients whose disease is at stages that warrant adjuvant chemotherapy, but the absolute difference in 5-year recurrence-free survival and overall survival with neoadjuvant chemotherapy as compared with surgery alone is only 5 to 6 percentage points and few patients have a complete pathological response. In this phase III trial authors randomly assigned patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. The median event-free survival was 31.6 months with nivolumab plus chemotherapy and 20.8 months with chemotherapy alone; the percentage of patients with a pathological complete response was 24.0% and 2.2%, respectively. The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery. On the basis of this trial, nivolumab in combination with chemotherapy has been approved in the United States as neoadjuvant treatment for adult patients with resectable NSCLC (tumors ≥4 cm or node positive).