Nintedanib (Vargatef®), an oral triple angiokinase inhibitor of VEGF-, PDGF- and FGF-receptors, is 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 scarce regarding efficacy and safety of nintedanib in NSCLC pts who had been pre-treated with ICIs.
This interim analysis is part of this ongoing trial and included 22 treated pts with locally advanced or metastatic lung adenocarcinoma who received nintedanib and docetaxel in 3rd line following ICIs in 2nd line.
Median age was 58 years (range: 45 – 76); 15/22 pts (68.2%) were men, 9/22 pts (40.9%) 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 included pemetrexed (15/22 pts, 68.2%), carboplatin (12/22 pts, 54.6%), cisplatin (12/22pts, 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 treatment included nivolumab (17/22 pts, 77.3%) and pembrolizumab (5/22 pts, 22.7%). Under nintedanib and docetaxel, 7/12 pts (58.3%) showed a partial response, and 3/12 pts (25.0%) showed stable disease, resulting in a DCR of 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 occurred in 13/22 pts (59.1%), 11/22 pts (50.0%), and 7/22 pts (31.8%), respectively.
Nintedanib, in combination with docetaxel, showed clinically meaningful efficacy and an acceptable safety profile in a limited number of stage IIIB/IV lung adenocarcinoma patients following chemotherapy and ICIs. Larger studies are warranted to further explore the potential of nintedanib and docetaxel in this novel setting supporting anti-angiogenesis plus docetaxel as a subsequent therapeutic principle in patients progressing under ICI therapy.
NCT02392455.
Boehringer Ingelheim Pharma GmbH & Co. KG.
Boehringer Ingelheim Pharma GmbH & Co. KG.
W. Gleiber: Membership on an advisory board. J. Atz, R. Kaiser: Employee of Boehringer Ingelheim Pharma GmbH & Co KG. All other authors have declared no conflicts of interest.