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