FDA approves maintenance olaparib-bevacizumab for HRD-positive advanced ovarian cancer

  • FDA
  • 8 May 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved olaparib+bevacizumab for first-line maintenance treatment of adult patients with homologous recombination deficiency (HRD)-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who experienced a response to first-line platinum-based chemotherapy.
  • The recommended dose:
    • Olaparib: 300 mg twice daily, with or without food.
    • Bevacizumab: 15 mg/kg intravenously every 3 weeks.
  • The FDA also approved the Myriad myChoice CDx as a companion diagnostic for olaparib.

Why this matters

  • HRD testing in ovarian cancer is critical for the diagnosis and tailoring of treatment.

Key highlights

  • Approval was based on a randomized, phase 3 PAOLA-1 trial.
  • Randomization was stratified by first-line treatment outcome and tumor BRCA mutation (tBRCAm) status.
  • All clinical samples were retrospectively tested with Myriad myChoice CDX test.
  • Patients were randomly allocated (2:1) to receive first-line maintenance olaparib+bevacizumab (n=537) or placebo+bevacizumab (n=269).
  • Estimated median PFS in the patients with HRD-positive tumors with olaparib+bevacizumab vs placebo+bevacizumab was 37.2 vs 17.7 months (HR, 0.33; 95% CI, 0.25-0.45).
  • OS data were not mature.
  • The most common adverse reactions (≥10% of patients) were nausea, fatigue (including asthenia), anemia, lymphopenia, vomiting, diarrhea, neutropenia, leukopenia, urinary tract infection, and headache.

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