Abstract
The PD-1 inhibitor nivolumab has activity in advanced, refractory squamous NSCLC.
Major finding: The PD-1 inhibitor nivolumab has activity in advanced, refractory squamous NSCLC.
Concept: Nivolumab induces durable objective responses and has a manageable safety profile.
Impact: Further studies of nivolumab as a first-line and second-line treatment in NSCLC are ongoing.
Treatment options for patients with advanced squamous non–small cell lung cancer (NSCLC) are limited, and the prognosis for patients with refractory disease is very poor. A phase I clinical trial suggested that treatment with nivolumab, a fully human antibody that inhibits the immune checkpoint protein programmed cell death 1 (PD-1), enhanced antitumor immune responses in patients with NSCLC, prompting Rizvi and colleagues to further evaluate the safety and efficacy of nivolumab in patients with advanced, refractory squamous NSCLC in a single-arm phase II trial. Nivolumab was administered to 117 patients with refractory stage IIIB or stage IV squamous NSCLC, most of whom had previously received at least three systemic treatments. Nivolumab treatment induced a partial response in 17 (14.5%) patients, including two patients with nontarget baseline central nervous system metastases, with a reduction in tumor burden of at least 50% for 11 (65%) of these responding patients. Treatment responses to nivolumab were ongoing in 13 (77%) of 17 responding patients and the median duration of response was not reached, indicative of durable responses. In addition, nivolumab treatment resulted in stable disease in 30 (26%) patients, with a median duration of 6 months. Median overall survival was 8.2 months and overall survival at one year was 40.8%. Analysis of archival pretreatment tumor samples revealed that nivolumab had activity in patients whose tumors expressed the PD-1 ligand PD-L1, as well as in patients with PD-L1–negative tumors. Consistent with phase I data, nivolumab exhibited a manageable safety profile; treatment-related immune-mediated adverse events were generally low grade, and grade 3–4 treatment-related adverse events occurred in 20 (17%) of 117 patients. These findings demonstrate the antitumor activity of nivolumab in advanced, refractory squamous NSCLC and support additional ongoing clinical studies of this inhibitor as first-line and second-line treatment.
Note: Research Watch is written by Cancer Discovery Science Writers. Readers are encouraged to consult the original articles for full details. For more Research Watch, visit Cancer Discovery online at http://CDnews.aacrjournals.org.
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