other_material
confidence high
sentiment positive
materiality 0.75
Positive Phase 1b firmonertinib data; 16.0 mo mPFS at 240 mg; global Phase 3 ALPACCA planned H2 2025
ArriVent BioPharma, Inc.
- 16.0 months median PFS by BICR at 240 mg dose in first-line EGFR PACC mutant NSCLC; 68.2% confirmed ORR at 240 mg.
- 41% (7/17) confirmed CNS complete response; 53% CNS ORR in CNS-evaluable patients by BICR.
- Safety consistent with prior data: no Grade 4/5 TRAEs, no discontinuations due to TRAEs; most common TRAEs diarrhea, elevated liver enzymes, rash.
- Firmonertinib 240 mg selected for pivotal Phase 3; ALPACCA trial enrollment expected to start H2 2025.
item 7.01item 8.01item 9.01