other material
confidence high
sentiment positive
materiality 0.85
Actuate Therapeutics: elraglusib Phase 2 meets primary endpoint; 1-year survival 43.6% vs 22.5% in mPDAC
ACTUATE THERAPEUTICS, INC.
- 1-year survival rate 43.6% in elraglusib+GnP arm vs 22.5% in GnP alone (p=0.002); median OS 9.3 vs 7.2 months (HR=0.63, p=0.016).
- 37% reduction in risk of death; ORR 27.7% vs 20.5%; multiple patients with complete/partial responses and 100% target lesion reduction.
- Favorable safety profile; TEAEs and SAEs similar between arms; 2 patients with previously inoperable lesions successful resected.
- Trial fully enrolled (286 patients); topline data expected 1H 2025; planned FDA engagement for Phase 3 registration trial.