Abstract 2739
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.
Editorial acknowledgement
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. Krüger: 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.
Resources from the same session
4615 - Proteomic Profiling Identifies Molecular Basis of Adverse Event to BPM31510 Exposure: Rationale for Comprehensive Molecular Pharmacodynamics (PD) in Phase 1 Clinical Trial Design
Presenter: Vivek Subbiah
Session: Poster Display session 1
Resources:
Abstract
5052 - Identification of first-in-class, naturally occurring LAG3 checkpoint inhibitor
Presenter: Gennady Bratslavsky
Session: Poster Display session 1
Resources:
Abstract
5336 - Are Epigenetic therapies modifying sensitivity to conventional chemotherapy?
Presenter: Alexandra Bizot
Session: Poster Display session 1
Resources:
Abstract
5739 - Oncogenic mutations at the dimer interface of EGFR lead to formation of covalent homo-dimers and allosteric activation of the kinase domain: A mechanism which alters the selectivity profile of oncogenic EGFR.
Presenter: Elizabeth Buck
Session: Poster Display session 1
Resources:
Abstract
5492 - Basic selective estrogen receptor degraders (B-SERDs) in combination with novel BET inhibitors in ER+ breast cancer
Presenter: Rui Xiong
Session: Poster Display session 1
Resources:
Abstract
5965 - EPI-7386 is a novel N-terminal domain androgen receptor inhibitor for the treatment of prostate cancer
Presenter: Ronan Le Moigne
Session: Poster Display session 1
Resources:
Abstract
3582 - AVID200 neutralizes TGF-beta1 and -beta3, the principal immunosuppressive TGF-beta isoforms overexpressed by tumors, and sensitizes tumors to immune checkpoint inhibitors.
Presenter: Tina Gruosso
Session: Poster Display session 1
Resources:
Abstract
1996 - High NAMPT expression and anti-tumor activity of NAMPT inhibitor in adult T-cell leukemia/lymphoma
Presenter: Tomohiro Kozako
Session: Poster Display session 1
Resources:
Abstract
4307 - TPX-0046 is a novel and potent RET/SRC inhibitor for RET-driven cancers
Presenter: Alexander Drilon
Session: Poster Display session 1
Resources:
Abstract
4869 - In Vivo Evaluation of Cisplatin-loaded PEG-PCL Block Copolymeric Nanoparticles for Anticancer Drug Delivery
Presenter: Yingtzu Yen
Session: Poster Display session 1
Resources:
Abstract