Renal cancer: add-on dalantercept with axitinib fails phase 2 trial

  • Voss MH & al.
  • Cancer
  • 5 Apr 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The addition of dalantercept to axitinib fails to improve PFS in previously treated patients with advanced clear cell renal cell carcinoma (RCC).

Why this matters

  • Dalantercept+axitinib showed encouraging efficacy signal and tolerance in a dose-escalation study (part 1 DART study).

Study design

  • Phase 2, randomized, double-blind DART (part 2) study of 124 patients with advanced clear cell RCC who progressed on VEGF pathway inhibitor treatment.
  • Patients were randomly assigned to receive either axitinib plus dalantercept (n=59) or placebo+axitinib (n=65).
  • Primary endpoint: PFS
  • Funding: Acceleron Pharma Inc.

Key results

  • Median PFS was not significantly different in dalantercept+axitinib vs placebo group (median, 6.8 vs 5.6 months; HR, 1.11; P=.670).
  • Median OS was not reached in either group (HR, 1.39; P=.349).
  • The objective response rate was 19% with dalantercept+axitinib vs 25% in the placebo group (P=.432).
  • 59% of patients in the dalantercept+axitinib group and 64% in the placebo group experienced grade ≥3 adverse events.
  • 1 treatment-related death was reported in the placebo group.

Limitations

  • Open-label design.

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