OncoImmunology (Jan 2020)

Effectiveness and safety of nivolumab in the treatment of lung cancer patients in France: preliminary results from the real-world EVIDENS study

  • Fabrice Barlesi,
  • Adrien Dixmier,
  • Didier Debieuvre,
  • Christophe Raspaud,
  • Jean-Bernard Auliac,
  • Nicolas Benoit,
  • Pierre Bombaron,
  • Denis Moro-Sibilot,
  • Clarisse Audigier-Valette,
  • Bernard Asselain,
  • Thomas Egenod,
  • Audrey Rabeau,
  • Jérôme Fayette,
  • Myriam Locatelli Sanchez,
  • Jean-Luc Labourey,
  • Virginie Westeel,
  • Pauline Lamoureux,
  • François-Emery Cotte,
  • Victoria Allan,
  • Melinda Daumont,
  • Juliette Dumanoir,
  • Dorothée Reynaud,
  • Christophe Yannick Calvet,
  • Nicolas Ozan,
  • Maurice Pérol

DOI
https://doi.org/10.1080/2162402X.2020.1744898
Journal volume & issue
Vol. 9, no. 1

Abstract

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EVIDENS is an ongoing, prospective, non-interventional study evaluating the effectiveness and safety of nivolumab in lung cancer patients in France (ClinicalTrials.gov NCT03382496). Adults with a pathologically confirmed diagnosis of lung cancer and initiating treatment with nivolumab were recruited from 146 sites in France. This analysis included only patients with non-small cell lung cancer (NSCLC) who received ≥1 nivolumab infusion, and evaluated patient characteristics at the time of nivolumab initiation and its effectiveness and safety after a median follow-up of 18 months. A total of 1,420 patients with NSCLC were included, most of whom had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1 (82.9%), non-squamous histology (69.2%) and stage IV disease (91.4%). Brain metastases were present in 19.9% of patients. Nivolumab was a second-line or ≥third-line regimen in 73.6% and 26.1% of patients, respectively. Almost all patients had prior chemotherapy (99.7%). Median overall survival was 11.2 months (95% confidence interval [CI]: 10.0–12.4). ECOG PS, smoking status, corticosteroids at baseline, epidermal growth factor receptor mutation status, presence of symptomatic brain metastases and treatment-related adverse events (TRAEs) were independent predictors of survival. Grade 3 and 4 TRAEs were reported in 105 (7.4%) and 12 (0.8%) patients, respectively; no treatment-related deaths were reported. Preliminary results of the EVIDENS study confirm the effectiveness and safety of nivolumab, mostly in pre-treated advanced NSCLC patients, with similar benefits to those observed in the phase III randomized clinical trials, despite a broader study population.

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