Nivolumab is the first checkpoint inhibitor approved for the treatment of non-Squamous non-small cell lung cancer (non-Sq-NSCLC). In previous studies, a greater clinical benefit was shown in current and former smokers than in never smokers and in EGFR mutated patients (pts). Nevertheless, no data are available from a real-world setting. Here we report the data from Italian expanded access program (EAP) in the never smoker pts and EGFR mutated pts.
Nivolumab was provided upon physicians’ request for pts aged ≥18 years 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 for ≤24 months. Pts included in the analysis received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events.
Of 1588 patients with non-Sq-NSCLC, 305 (19%) were never smokers and, among 1455 pts evaluable for EGFR mutation, 102 (7%) were positive. In the never smoker group, EGFR status was available for 287 pts, with 51 (19%) who harbored an activating EGFR mutation. Among never smokers, with a median follow-up (FU) of 7.0 months (0.1-20.3) and a median of 7 doses (1-38), the objective response rate (ORR), the disease control rate (DCR) and the median overall survival (OS) were 9%, 42% and 10.0 months (8.1-11.9), respectively. Among all EGFR positive pts, with a median FU of 5.5 months (0.1-20.9) and a median of 6 doses (1-40), the ORR, DCR and median OS were 9%, 30% and 8.3 months (2.2-14.4), respectively. In the never smoker group, EGFR positive pts had 2% ORR, 26% DCR and 5.6 months (3.4-7.8) of median OS. However, it should be considered that these pts had poorer prognostic factors (ECOG performance status, brain metastasis) at baseline.
These preliminary results represent the first real-life data regarding the efficacy of nivolumab in special subpopulations, including never smokers and EGFR positive pts. Even if ORR and OS seem lower than in general population, due to lack of alternatives and good safety profile, nivolumab should be considered as a therapeutic option.
Clinical trial identification
Legal entity responsible for the study
M.C. Garassino: Potential conflict of interest with: Bristol-Myers Squibb, Roche, AstraZeneca. H.J. Soto Parra: Advisory board of: AstraZeneca, Bristol-Myers Squib, Lilly, MSD, Merck Sharp & Dohme AG. F. De Marinis: Potential COI with: Boehringer Ingelheim, MSD, AstraZeneca, BMS, Celgene, Novartis, Pfizer, Roche/Genentech, Pierre-Fabre All other authors have declared no conflicts of interest.