Use of nivolumab in elderly patients with advanced non-squamous NSCLC: Results from the Italian expanded access program (EAP)

Abstract

Background: The efficacy and safety of nivolumab in patients with non-squamous nonsmall cell lung cancer (Non-Sq-NSCLC) have been demonstrated in several trials including the phase 3, randomized, controlled CheckMate 057 study which led to the approval of the product for this indication. However, data on the use of nivolumab in the real- BVLworld setting is still limited. The Italian nivolumab EAP forNon-Sq-NSCLC represents an important source of information. The current analysis describes results of the use of nivolumab in the group of EAP patients (pts) aged>70 and>75 years. Methods: Nivolumab was available upon physician request for pts aged ≥18 yearswho had relapsed after a minimumof one prior systemic treatment for stage IIIB/IVNon-Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to amaximumof 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events. Results: Of 1588 Italian pts with advanced non-Sq-NSCLC participating in the EAP in Italy, 522 (33%) were ≥70 years and 232 (15%) were ≥75 years. Themedian follow up was 7.6months (0.1-20.8) and 8.3 (0.1-20), respectively. For pts aged ≥70, median number of doses was 9 (1-44) and the disease control rate (DCR) was 48%, including 2 pts with a complete response (CR), 106pts with a partial response (PR) and 145 with stable disease (SD). For pts aged ≥75, median number of doses was 11 (1-39) and theDCR was 53%, including 58pts with a PR and 64 with SD. Among pts aged>70, 403 discontinued treatment for any reason, with only 25 (5%) discontinuation due to related AEs vs 177 discontinuation for any reason, with only 13 (6%) due to related AEs among pts aged>75. As of March 2017, median overall survival was 11.5months (10.0-13.0) and 12.0months (9.2-14.8) respectively in ptsaged ≥70 and ≥75. The efficacy, safety and drug-related discontinuation results are in line with what observed in the general population. Conclusions: These results suggest that elderly population receive similar benefit from nivolumab treatment both in term of efficacy and safety than younger patients, supporting the use of nivolumab in this subpopulation.