Advanced RCC: dalantercept shows promise in phase 2 trial

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Takeaway
  • Dalantercept plus axitinib (Inlyta) demonstrated a favorable safety profile and clinically meaningful antitumor activity in patients with previously treated renal cell carcinoma (RCC).
Why this matters
  • Dual angiogenic blockade is appealing considering the limited duration of activity of vascular endothelial growth factor (VEGF) inhibitors due to the development of resistance.

Key results

  • 62% of participants had ≥2 prior therapies. 
  • No dose-limiting toxicities, grade 4/5 drug-related adverse events (AEs), or serious bleeding in dose-escalation cohorts. 
  • Common treatment-emergent AEs included fatigue, diarrhea, peripheral edema, nausea, increased creatinine, epistaxis, pericardial effusion, and telangiectasias. 
  • Pericardial and pleural effusions occurred in 21% and 14%, respectively, and were deemed to be possibly related to dalantercept. 
  • 7 (25.0%) patients achieved partial response, 17 (60.7%) had stable disease, and 4 (14.3%) had progressive disease as best response. 
  • No patients achieved complete response. 
  • Median PFS was 8.3 mo. 
  • After cycle 1, there was a 73% mean reduction in VEGFR3 compared with baseline (P<.001).

Study design

  • Open-label phase 2 trial of dalantercept 0.6 (n=6), 0.9 (n=4), or 1.2 mg/kg (n=5) subcutaneously every 3 wk plus axitinib 5 mg twice-daily in 29 patients assigned to dose-escalation (n=15) and expansion (n=14) cohorts. 
  • Funding: Acceleron Pharma.

Limitations

  • Small sample. 
  • Open-label.