Preliminary efficacy and safety data of nivolumab in never smoker patients with advanced squamous NSCLC: Experience from Italian sites participating in the Expanded Access Programme (EAP)

Background: Nivolumab is the first checkpoint inhibitor approved for the treatment ofsquamous non-small cell lung cancer (Sq-NSCLC) to show a survival benefit in arandomised phase III trial. In prior studies nivolumab has shown a better clinicalbenefit in current and former smokers compared to never smokers. Nevertheless, no data are available from a real world setting. The EAP provided an opportunity toevaluate the feasibility of treatment in this patient population outside of a controlledclinical trial in Italy.Methods: Nivolumab was available upon physician request for patients (pts) aged ≥18years 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 weeksto a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose ofnivolumab and were monitored for adverse events using Common TerminologyCriteria for Adverse Events.Results: Of 372 patients with Sq-NSCLC participating in the EAP in Italy, 38 (10.2%)were never smokers, in line to what observed in the registrational study Checkmate 017(10%). With a median number of doses 8 (range, 1–22) and a median follow-up of 5.6months, the disease control rate was 50%, including 9 patients with a partial responseand 10 with stable disease. Eight pts were treated beyond RECIST defined progression,with 4 of these pts achieving a disease control. As of April 2016, medianprogression-free survival and overall survival were 3.5 months and not reached,respectively. Among 38 pts, 17 pts (44.7%) discontinued treatment for any reasonexcept toxicity; 5 out of 38 discontinued due to AE (13.1%).Conclusions: With the limitation of a small sample size and type of study (EAP), thesedata seem to suggest that nivolumab might have a similar efficacy in non-smoker patientsto that observed in the overall population, warranting further investigation in this area.