Efficacy and safety data from patients with advanced squamous NSCLC and brain metastases participating in the nivolumab Expanded Access Programme (EAP) in Italy

Abstract

Background: Brain metastases are a very common secondary localization of disease in patients ( pts) with lung cancer. The prognosis of these pts is still poor and they are usually excluded from clinical trials. The EAP provided an opportunity to evaluate the feasibility of nivolumab treatment in this patient population outside of a controlled clinical trial in Italy. Methods: Nivolumab was available upon physician request for pts aged ≥18 years with a diagnosis of squamous non-small cell lung cancer (Sq-NSCLC) who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg is administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events using Common Terminology Criteria for Adverse Events. Results: Of 372 patients with Sq-NSCLC participating in the EAP in Italy, 38 (10.2%) had asymptomatic and controlled brain metastases. With a median number of doses 6 (range, 1-18) and a median follow-up of 4.5 months, the disease control rate was 47.3%, comprising 1 pt with a complete response, 6 patients with a partial response and 11 with stable disease. Four pts were treated beyond RECIST defined progression. As of April 2016, median progression-free survival and overall survival among patients with brain metastases were 5.5 months and 6.5 months, respectively. Among 38 pts, 21 pts (55.3%) discontinued treatment for any reason except toxicity; 1 out of 38 discontinued due to AE (2.6%). Conclusions: These preliminary data show efficacy of nivolumab in patients with Sq-NSCLC with brain metastases, with safety results consistent to what already reported in previous studies, thus encouraging the use of nivolumab in this population with poor prognosis.