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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
Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free
About this update from Arrivent Biopharma, Inc.
[{"type":"text","content":"Firmonertinib has the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapyALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals NEWTOWN SQUARE, Pa., Dec. 22, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC). Firmonertinib is an oral, once daily, highly brain-penetrant and broadly active mutation-selective EGFR inhibitor. “Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib,” said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. “Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. With a well-characterized safety profile and broad clinical systemic and central nervous system (CNS) activity in patients, we believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum.” PACC mutations represent a distinct and underserved population of EGFR mutant NSCLC, with limited approved first-line targeted therapies and historically poor outcomes. The ALPACCA (FURMO-006) randomized, global Phase 3 study is evaluating firmonertinib 240 mg once daily versus investigator’s choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. The primary endpoints are overall response rate (ORR) and progression-free survival (PFS) by blinded independent central review (BICR). The 240 mg dose of firmonertinib was selected for pivotal development based on compelling data showing a 16-month median PFS and a confirmed 68% ORR by BICR in the FURTHER trial. The ALPACCA study is designed to support potential global registration with endpoints for accelerated and full approval pathways. We estimate that the global ex-China annual incidence of NSCLC ...