Abstract 1372P
Background
Nintedanib (Vargatef®) is an oral triple angiokinase inhibitor targeting VEGF-, PDGF- and FGF receptor pathways. It is approved in the EU and other countries for treatment of advanced adenocarcinoma NSCLC after 1st line chemotherapy. The treatment landscape in advanced NSCLC has undergone significant changes and ICI +/- chemotherapy has changed the standard of care for 1st line treatment of metastatic non-mutated NSCLC. The evaluation of the therapeutic sequence in respect to efficacy is key to understand the underlying mechanism of resistance to ICI and to improve the long-term treatment of the patients.
Methods
This updated analysis is part of the ongoing NIS VARGADO. The study consists of three cohorts, two of which allow for prior treatment with ICIs either in combination with chemotherapy in 1st line (cohort C) or as monotherapy in 2nd line treatment (cohort B). The current analysis includes 65 pts of cohort B. In cohort C, currently 57 patients have been enrolled and are under treatment or are being followed up.
Results
In cohort B, median age was 62 years (range: 41 – 80), 34/65 pts (52.3%) were men, and 47/65 pts (72.3%) were ECOG PS 0/1. 1st line treatments included pemetrexed (43/65 pts, 66.2%), cisplatin (31/65 pts, 47.7%), carboplatin (39/65 pts, 60.0%), bevacizumab (13/65 pts, 20.0%), vinorelbine (13/65 pts, 20.0%), paclitaxel (10/65 pts, 15.4%). 2nd line treatments included nivolumab, pembrolizumab, and atezolizumab. Under nintedanib and docetaxel, ORR was 50% (26/52 pts); DCR was 82.7% (43/52 pts). Median PFS was 6.5 months (95%CI 4.8 – 7.3), median OS was 12.2 months (95%CI 11.4 – 14.1). Treatment emergent adverse events (TEAEs) grade ≥3, serious TEAEs, and TEAEs leading to discontinuation were observed in 36/65 pts (55.4%), 34/65 pts (52.3%), and 22/65 pts (33.9%), respectively.
Conclusions
The data show that nintedanib + docetaxel provides encouraging and clinically meaningful efficacy and a manageable safety profile in this patient population, providing further evidence for the use in lung adenocarcinoma following ICIs and chemotherapy.
Clinical trial identification
NCT02392455.
Editorial acknowledgement
Legal entity responsible for the study
Boehringer Ingelheim Pharma GmbH & Co. KG.
Funding
Boehringer Ingelheim Pharma GmbH & Co. KG.
Disclosure
C. Grohé, W. Gleiber: Honoraria (self), Membership of Advisory Boards: Boehringer Ingelheim. S. Haas: Research grant/Funding (institution): Boehringer Ingelheim. S. Hammerschmidt: Honoraria (self), Advice, Talks and Clinical Trial Participation: Boehringer Ingelheim; Honoraria (self), Advice, Talks and Clinical Trial Participation: Roche; Honoraria (self), Advice, Talks and Clinical Trial Participation: MSD; Honoraria (self), Advice, Talks and Clinical Trial Participation: BMS; Honoraria (self), Advice, Talks and Clinical Trial Participation: Pfizer. S. Krüger: Honoraria (self), Research grant/Funding (institution): Boehringer Ingelheim. H. Mueller-Huesmann: Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): BMS; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Janssen. T. Wehler: Honoraria (self), Advice, Talks : Boehringer Ingelheim; Honoraria (self), Advice, Talks: Roche; Honoraria (self), Advice, Talks: Lilly; Honoraria (self), Advice, Talks: Novartis; Honoraria (self), Advice, Talks: MSD; Honoraria (self), Advice, Talks: BMS; Honoraria (self), Advice, Talks: AstraZeneca; Honoraria (self), Advice, Talks: Pfizer; Honoraria (self), Advice, Talks: Takeda. J. Atz, R. Kaiser: Full/Part-time employment: Boehringer Ingelheim. All other authors have declared no conflicts of interest.