Efficacy and safety data from patients with advanced non-squamous NSCLC and brain metastases from 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 offered an opportunity to evaluate nivolumab treatment in these patients outside of a controlled clinical trial in Italy. Methods: Nivolumab was available upon physician request for pts aged ≥18 years with a diagnosis of non-squamous non-small cell lung cancer (non-Sq-NSCLC) who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non- Sq-NSCLC. Nivolumab 3 mg/kg was 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. Pts with brain metastasis were eligible if asymptomatic, neurologically stable and either off corticosteroids or on a stable dose or decreasing dose of ≥10 mg daily prednisone. Results: Of 1588 patients with non-Sq-NSCLC participating in the EAP in Italy, 409 (26%) had asymptomatic and controlled brain metastases. With a median number of 7 doses (1-45) and a median follow-up of 6.1 months (0.1-21.9), the disease control rate was 40%, including 3 pts with a complete response, 65 patients with a partial response and 96 with stable disease. As of March 2017, median overall survival among patients with brain metastases was 8.1 (6.2-10.1) months. Among these pts, 117 were receiving steroid therapy at baseline and 74 received concomitant radiotherapy. Overall, safety profile and discontinuations for drug-related toxicity were consistent with what observed in the general population. Conclusions: These preliminary data showed efficacy of nivolumab in patients with non-Sq-NSCLC with brain metastases, with safety results consistent to what already reported in controlled clinical trials, thus supporting the use of nivolumab in this population with poor prognosis.