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Judith Atz

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    Mini Oral session II (ID 63)

    • Event: ELCC 2019
    • Type: Mini Oral session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 16:40 - 17:40, Room C
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      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 (ID 467)

      16:40 - 17:40  |  Presenting Author(s): Judith Atz

      • Abstract
      • Presentation
      • Slides


      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.

      a9ded1e5ce5d75814730bb4caaf49419 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).

      20c51b5f4e9aeb5334c90ff072e6f928 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.

      fd69c5cf902969e6fb71d043085ddee6 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.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification


      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Boehringer Ingelheim Pharma GmbH & Co. KG.

      213f68309caaa4ccc14d5f99789640ad Funding

      Boehringer Ingelheim Pharma GmbH & Co. KG.

      682889d0a1d3b50267a69346a750433d 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.


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