Italian nivolumab expanded access programme: real-world results in non-squamous non-small cell lung cancer patients

Abstract

Background: Nivolumab monotherapy has shown survival benefit in patients (pts) with different tumors, including melanoma, lung cancer, renal cell carcinoma and head and neck cancer. The experience of pts and physicians in routine clinical practice is often different from that in a controlled clinical trial setting. Here, we report efficacy and safety of nivolumab monotherapy in pts with non-squamous non-small cell lung cancer (NSCLC) treated in the nivolumab Expanded Access Programme in Italy. Methods: Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Squamous NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received at least 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events. Results: In total, 1588 Italian pts participated in the EAP across 168 centers. Baseline characteristics of pts were representative of the population with non-squamous NSCLC, in the advanced disease setting. With a median follow-up of 7.8 months (1- 21.9) and a median of 7 doses, the overall response rate (ORR) was 18%, including 10 pts (<1%) with complete response and 280 pts (17%) with partial response. Stable disease has been defined for 414 pts (26%) and totally 279 patients were treated beyond progression. As of March 2017, median overall survival (OS) was 11 months (range: 10.0-12.0). Response rates and survival were comparable among pts regardless age (< and≥ 75 years), presence of brain metastasis and number of prior therapies. Overall, among 1588 pts, 1254 discontinued treatment for any reason, with only 80 pts (5%) who discontinued treatment due to related adverse events. Conclusions: To date, this is the largest clinical experience with nivolumab in a realworld setting. These preliminary EAP data confirm that nivolumab seems to be an effective and safe therapy for pre-treated patients with non-squamous NCSLC, supporting its use in current clinical practice.