119OEfficacy and safety of nintedanib + docetaxel in lung adenocarcinoma patients (pts) following treatment with immune checkpoint inhibitors (ICIs): First results of the ongoing non-interventional study (NIS) VARGADO

Background: Nintedanib (Vargatef®) is an oral triple angiokinase inhibitor of VEGF-, PDGF- and FGF-receptors approved in the EU and other countries for treatment of locally advanced or metastatic NSCLC of adenocarcinoma histology in combination with docetaxel after 1st line chemotherapy. Data are sparse regarding efficacy and safety of nintedanib in NSCLC pts who had been treated with ICIs. Methods: This interim analysis included 22 pts with locally advanced or metastatic lung adenocarcinoma who received nintedanib and docetaxel in 3rd line following ICIs in 2nd line within the ongoing NIS VARGADO (cohort B). Results: Median age was 58 years (range: 45 – 76), 15/22 pts (68.2%) were men, and 16/22 pts (72.7%) were ECOG PS0/1. 4/22 pts (18.2%) had brain metastases, and 19/22 pts (86.4%) were current or former smokers. 1st line chemotherapy treatments included pemetrexed (15/22 pts, 68.2%), carboplatin (12/22 pts, 54.6%), cisplatin (12/22 pts, 54.6%), bevacizumab (6/22 pts, 27.3%), vinorelbine (4/22 pts, 18.2%), paclitaxel (2/22 pts, 9.1%), and docetaxel (1/22 pts, 4.4%). 2nd line treatments consisted of nivolumab (17/22 pts, 77.3%) or pembrolizumab (5/22 pts, 22.7%). Under nintedanib and docetaxel, 7/12 pts (58.3%) developed a partial response and 3/12 pts (25.0%) showed stable disease; DCR was 83.3% (10/12 pts). Median PFS was 5.5 months (95%CI 1.9 – 8.7). Treatment emergent adverse events (TEAEs) grade ≥3, serious TEAEs, and TEAEs leading to discontinuation were observed in 13/22 pts (59.1%), 11/22 pts (50.0%), and 7/22 pts (31.8%), respectively. Conclusions: Nintedanib, in combination with docetaxel, showed clinically relevant efficacy and an adequate safety profile in stage IIIB/IV lung adenocarcinoma pts following treatment with chemotherapy and ICIs. Further studies are justified to fully explore the potential of nintedanib and docetaxel in this novel setting. Therefore, anti-angiogenesis plus docetaxel may emerge as a subsequent therapeutic principle in patients progressing under ICI therapy. Clinical trial identification: NCT02392455. Legal entity responsible for the study: Boehringer Ingelheim Pharma GmbH & Co. KG. Funding: Boehringer Ingelheim Pharma GmbH & Co. KG. Disclosure: C. Grohe: Research funding/honoraria: AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, MSD, Pfizer, Hoffmann-La Roche, Lilly including membership on advisory boards. W. Gleiber: Honoraria for membership on advisory boards: Boehringer Ingelheim. J. Atz, R. Kaiser: Employee: Boehringer Ingelheim Pharma GmbH & Co. KG All other authors have declared no conflicts of interest.