Parabilis Medicines Presents Updated Phase 1/2 Data for Zolucatetide Demonstrating Compelling Efficacy and Favorable Safety and Tolerability Profile in Patients with Desmoid Tumors
Parabilis Medicines presented updated Phase 1/2 data for zolucatetide in desmoid tumors at ESMO 2026, showing a 72.2% objective response rate at the 32-week landmark among patients starting at ≥450 mg. Disease control was 100% across 46 response-evaluable patients with no disease progression and no treatment discontinuations due to side effects, and responses occurred regardless of prior gamma-secretase inhibitor exposure. The company has reached FDA alignment on dose, placebo-controlled design, and progression-free survival as the primary endpoint for the PEDESTAL Phase 3 trial, planned to start in the first half of 2027 with topline results in 2029.
Key figures
- Drug Name
- zolucatetide
- Phase Of Trial
- Phase 1/2
- Dcr
- 100% across 46 response-evaluable patients
- Orr
- 72.2% (13/18) at 32-week landmark for ≥450 mg starting dose
- Phase3 trial
- PEDESTAL, initiation planned H1 2027, topline anticipated 2029
- Patients enrolled
- 76
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