Heavily treated ovarian cancer: avelumab does well in phase 1b JAVELIN

  • Disis ML & al.
  • JAMA Oncol
  • 24 Jan 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Avelumab shows antitumor activity and acceptable safety in heavily pretreated patients with recurrent or refractory ovarian cancer who progressed on platinum-based chemotherapy.
  • Responses were irrespective of programmed death-ligand 1  (PD-L1) and BRCA status.

Why this matters

  • Standard therapies for platinum-resistant or -refractory disease show limited benefits.
  • Findings warrant further evaluation.

Study design

  • Phase 1b, open-label JAVELIN Solid Tumor study of 125 patients with heavily pretreated recurrent or refractory ovarian cancer who progressed on platinum-based chemotherapy.
  • Funding: Merck KGaA, Darmstadt, Germany.

Key results

  • Patients received median 3 lines of prior chemotherapy.
  • Objective response rate (ORR) was 9.6% and immune-related ORR was 12.8%.
  • 8.8% of patients had partial responses and 0.8% had complete response.
  • Disease control rate was 52.0%.
  • Median time to response was 8.9 weeks and median duration of response was 10.4 months.
  • Median PFS was 2.6 (95% CI, 1.4-2.8) months and OS was 11.2 (95% CI, 8.7-15.4) months.
  • ORR in patients with PD-L1-positive and -negative tumors was 11.8% and 7.9%, respectively.
  • ORR in patients with BRCA-mutated and -wildtype tumors was 12.5% and 7.9%, respectively.
  • Treatment-related adverse event (AE) rate: any grade, 68.8%; grade 3-4, 7.2%.
  • 33.6% of patients reported serious AEs.
  • 20.0% of patients experienced infusion-related AEs and 16.8% had immune-related AEs.
  • Other common any-grade AEs were fatigue (13.6%), diarrhea (12.0%), and nausea (11.2%).

Limitations

  • Single-arm design.

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