119O - Efficacy 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

Abstract

Abstract Background Nintedanib (Vargatef®) is an oral triple angiokinase inhibitor of VEGF-, PDGF- and FGF-receptors approved in the EU and other countries in combination with docetaxel for treatment of locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma histology after 1st line chemotherapy. Data are sparse regarding efficacy and safety of nintedanib in adenocarcinoma pts who had been pre-treated with ICIs. Methods This interim analysis included 32 pts with locally advanced, metastatic or locally recurrent lung adenocarcinoma who received nintedanib and docetaxel in 3rd line following ICIs in 2nd line within the ongoing NIS VARGADO (cohort B); it updates and extends data previously presented at ESMO IO 2018. Results Median age was 60 years (range: 45 – 76), 21/32 pts (65.6%) were men, and 22/32 pts (68.8%) were ECOG PS0/1. 7/32 pts (21.9%) had brain metastases, and 25/32 pts (78.1%) were current or former smokers. 1st line chemotherapy treatments included pemetrexed (23/32 pts, 71.9%), cisplatin (20/32 pts, 62.5%), carboplatin (16/32 pts, 50.0%), bevacizumab (9/32 pts, 28.1%), vinorelbine (5/32 pts, 15.6%), paclitaxel (2/32 pts, 6.3%), and docetaxel (1/32 pts, 3.1%). 2nd line treatments included nivolumab (21/32 pts, 65.6%), pembrolizumab (7/32 pts, 21.9%), and atezolizumab (3/32 pts, 9.4%). Under nintedanib and docetaxel, 12/24 pts (50.0%) developed a partial response and 7/24 pts (29.2%) showed stable disease; DCR was 79.2% (19/24 pts). Median PFS was 7.1 months (95%CI 2.9 – 8.2). Treatment emergent adverse events (TEAEs) grade ≥3, serious TEAEs, and TEAEs leading to discontinuation were observed in 18/32 pts (56.3%), 16/32 pts (50.0%), and 12/32 pts (37.5%), respectively. Conclusions In this updated analysis, 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. Data highlight the potential clinical benefit of rational treatment sequencing with anti-angiogenic therapy after ICIs. 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: Advisory / Consultancy, Membership on advisory board: Boehringer Ingelheim. W. Gleiber: Advisory / Consultancy, Membership on advisory board: Boehringer Ingelheim. S. Kruger: Advisory / Consultancy, Membership on advisory board: Boehringer Ingelheim. M. Schulze: Advisory / Consultancy, Membership on advisory board: Boehringer Ingelheim. J. Atz: Full / Part-time employment: Boehringer Ingelheim. R. Kaiser: Full / Part-time employment: Boehringer Ingelheim. All other authors have declared no conflicts of interest.