1468PGECP 1605/NIVEX TRIAL nivolumab in the real world: The SPANISH expanded access program experience in pretreated advanced NSCLC

Background: Nivolumab is a standard treatment for second line in patients (pts) with advanced NSCLC. Real world data about toxicity and efficacy of nivolumab is lacking. Methods: We have analyzed 665 pts from the Expanded Access Program, which included pts with pretreated NSCLC who received ≥1dose of nivolumab 3mg/kg q2w from 01/2015 for squamous (Sq) and 06/2015 for non‐Sq NSCLC, to 11/2017. Results: Median age was 61 (32-85) years, 73% were men, 85% had ECOG 0-1, 88% were current/former smokers and 15% had brain M1. 128 (19.2%) pts presented Sq and 537 (80.8%) Non‐Sq NSCLC. 7% of pts presented EGFR mutation. PD-L1 was ≥1% in 33% of analyzed pts. Nivolumab was administered as 2nd/≥3rd line in 33% and 67% of pts. Post-nivolumab treatment was administered to 25% pts that received nivolumab in 2nd line and to 23% that received nivolumab in 3rd line. After a median follow‐up of 8.2 months, the median OS was 8-97 (95% CI 7.69-10.24) months, and the median PFS was 3.23 (95% CI 2.77-3.70) months. Estimated 1-year OS was 42.4% (95%CI 38.5-42.8%) and estimated 1-year PFS was 22.2% (95% CI 19.1-25.3%). No differences in OS or PFS were observed according to histologies. Among pts that received nivolumab in 2nd line, the median OS was 9.8 (95% CI 7.3-12.0) months and the median PFS was 3.3 (95%CI 2.4-4.2) months. Among pts that received nivolumab in ≥ 3rd line the median OS was 8.6 (95% CI 7.2-10.0) months and the median PFS was 3.1 (95% CI 2.6-3.7) months. Median OS for pts that received post-nivolumab treatment in 3rd line was 9.3 (95 CI% 7.0-11.6) months. 296 (44.5%) pts presented toxicity to nivolumab, which was grade ≥3 in 69 (10.4%) pts. According to the presence of grade ≥3 toxicity, the median OS was 14.57 (CI 95% 8.45-20.68) months for pts with and 8.73 (CI 95% 7.50-9.96) months for pts without grade≥3 toxicity (p = 0.074). Additional efficacy and safety data, including PS2, brain M1, response to first line, or post-nivolumab treatment will be presented. Conclusions: Efficacy and safety of nivolumab was in line with previously shown data. There was a trend to a better OS for those pts experiencing grade≥3 toxicity. Clinical trial identification: NCT03132493. Legal entity responsible for the study: Spanish Lung Cancer Group. Funding: BMS. Disclosure: All authors have declared no conflicts of interest.