- 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).
- 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.
- 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.
- Open-label design.