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.
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.
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.
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
Legal entity responsible for the study
Spanish Lung Cancer Group.
All authors have declared no conflicts of interest.