Intervista a Angelo Delmonte Italian cohort of nivolumab Expanded Access Programme (EAP): preliminary data from a real-world population Lucio Crinò et al. Intervista a Angelo Delmonte

Background: Nivolumab is the first checkpoint inhibitor approved for the treatment of squamous non small cell lung cancer (Sq-NSCLC) to show a survival benefit in a randomised phase III trial. The experience of patients and physicians in routine clinical practice is often different from those in a controlled clinical trial setting. The purpose of this analysis is to evaluate nivolumab use in real world setting. Methods: Nivolumab was available upon physician request for patients (pts) aged ≥ 18 years 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: In total, 371 Italian pts participated in the EAP across 96 centres. Table 1 shows pts baseline characteristics. With a median follow-up of 2 months (range 0-7), 139 pts are not yet evaluable for response; the disease control rate (DCR) among others 232 pts evaluable for response is 35.8%: one patient (0,4%) with complete response, 32 pts (13.8%) with partial response and 50 pts (21.6%) with stable disease. DCR is comparable among pts regardless previous lines of therapy, brain metastasis, age and smoking habits. To date, median time of treatment is 2 months, with 42 patients treated beyond progression. Among 370 pts, 99 pts (27%) discontinued treatment for any reason except toxicity; 16 out of 370 discontinued due to AE (4%). Conclusions: To date, this is the largest clinical experience with nivolumab in current clinical practice: nivolumab seems to be an effective and safe therapy for pre-treated pts with Sq-NCSLC. These preliminary data provide insights into routine clinical use of nivolumab and seems to confirm data from pivotal trials.