Nintedanib fails to boost survival in advanced ovarian cancer

  • Ray-Coquard I & al.
  • Int J Cancer
  • 5 Aug 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In final analysis of the AGO-OVAR 12 trial, add-on nintedanib failed to add survival benefit to standard front-line chemotherapy for newly diagnosed advanced epithelial ovarian cancer.
  • No new safety signals were reported.

Why this matters

  • Previously reported PFS advantage with nintedanib in a non-high-risk subgroup did not translate into an OS benefit; results do not favor nintedanib in ovarian cancer.

Study design

  • Final analysis of double-blind, randomized phase 3 GCIG/ENGOT/AGO-OVAR 12 trial of 1366 patients with newly diagnosed advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • After primary debulking surgery, patients were randomly assigned 2:1 to paclitaxel+carboplatin in combination with either oral nintedanib or placebo for 6 cycles; thereafter, nintedanib/placebo was continued as monotherapy for 120 weeks, disease progression, or unacceptable toxicity.
  • Funding: Boehringer Ingelheim, Ingelheim, Germany.

Key results

  • Median follow-up duration was 60.9 months.
  • In nintedanib vs placebo group:
    • Median OS was not significantly different (62.0 vs 62.8 months; HR, 0.99; P=.86).
    • Median PFS significantly improved (17.6 vs 16.6 months; HR, 0.86; P=.029).
    • PFS advantage was seen in non-high-risk patients (HR, 0.77; 95% CI, 0.64-0.93), but not in high-risk patients.
    • Grade ≥3 adverse events were more frequent (81% vs 67%).
  • No new safety signals were reported.

Limitations

  • 51.7% of nintedanib-treated patients required a dose reduction.