ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer
12/22/2025 08:00 AM • ArriVent BioPharma announced the first patient dosing in the Phase 3 ALPACCA pivotal trial evaluating firmonertinib for first-line treatment of EGFR PACC mutant NSCLC. The trial compares firmonertinib 240 mg once daily against osimertinib or afatinib, with primary endpoints of overall response rate and progression-free survival. The company estimates approximately 42,000 patients globally and 6,200 in the US annually with this mutation type.
AVBP - The company achieved a significant clinical milestone by initiating a pivotal Phase 3 trial for an underserved patient population. The drug has demonstrated compelling efficacy data (16-month median PFS, 68% ORR) and has received FDA Breakthrough Therapy Designation. The trial is designed to support accelerated and full regulatory approval pathways, indicating strong potential for commercialization.