Boehringer Ingelheim announced today the first interim results of VARGADO, an ongoing non-interventional study in routine clinical practice in Germany evaluating the efficacy and safety of Vargatef (nintedanib) and docetaxel in patients with stage III/IV locally advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma histology. The study consists of three cohorts, two of which allow for prior treatment with immune checkpoint inhibitors (ICIs) either in combination with chemotherapy in the first-line or as monotherapy in the second-line of treatment. The interim results from Cohort B (first-line chemotherapy, second-line immune checkpoint inhibitors, third-line Vargatef plus docetaxel) were presented today at ESMO Immuno-Oncology Congress 2018 in Geneva.1 Despite a limited sample size, the VARGADO study adds to the body of evidence for nintedanib in lung adenocarcinoma following pre-treatment with chemotherapy and ICIs.1,3
The addition of nintedanib to docetaxel has a proven survival benefit as a second-line treatment following chemotherapy in a broad population of lung adenocarcinoma patients.4 However, data are scarce regarding the efficacy and safety of nintedanib in adenocarcinoma patients who have been pre-treated with chemotherapy as well as ICIs.
The results support a recent update to the ESMO guidelines around the treatment of NSCLC, which now recommend nintedanib in combination with chemotherapy as a second-line treatment following prior chemotherapy +/- ICIs.2 A recent report by Jesus Corral et al (WCLC, 2017) which evaluated nintedanib in combination with docetaxel in a similar setting showed similar efficacy and safety information.3
Professor Christian Groh, Department of Respiratory Diseases, ELK Berlin, said: As immunotherapy becomes the first-line treatment of choice in advanced lung adenocarcinoma, its important to have effective and safe treatment options following immunotherapy. The results from VARGADO provide important evidence supporting the use of nintedanib following initial treatment with immunotherapy and are in line with the recent update to the ESMO guidelines.
Dr Victoria Zazulina, Global Head of Solid Tumour Oncology, Medicine at Boehringer Ingelheim, said: With a devastating disease like lung cancer, every option matters. Todays results provide evidence that nintedanib, when added to docetaxel, is a good therapeutic option for patients that progress following treatment with immunotherapy.
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