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ArriVent’s Topline Pivotal Phase 3 FURVENT Data for Firmonertinib in First-Line NSCLC EGFR Exon20 Insertion Mutations is Projected to be Early 2026
Enrollment in FURVENT was completed in Q1 2025 Firmonertinib received FDA Breakthrough Therapy Designation in this patient population NEWTOWN SQUARE, Pa.,
About this update from Arrivent Biopharma, Inc.
[{"type":"text","content":"Enrollment in FURVENT was completed in Q1 2025 Firmonertinib received FDA Breakthrough Therapy Designation in this patient population NEWTOWN SQUARE, Pa., July 21, 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 topline firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study in first-line EGFR exon20 insertion mutant non-small cell lung cancer (NSCLC) is projected to be in early 2026. The primary endpoint will assess progression free survival (PFS) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In the first quarter of 2025, the study completed enrollment across global sites. About FURVENT FURVENT is a global, pivotal 3 arm Phase 3 clinical trial of firmonertinib in first-line non-squamous locally advanced or metastatic NSCLC patients with exon 20 insertion mutations being conducted jointly with our partner Allist. The FURVENT clinical trial is designed to assess the safety and efficacy of firmonertinib administered at either 160 mg or 240 mg, once-daily with each dose being compared to platinum-based chemotherapy with pemetrexed, the current first-line standard of care. The primary endpoint of this study is PFS by BICR per RECIST 1.1. Secondary endpoints in patients with brain metastases at baseline include brain-specific CNS overall response rate (CNS-ORR) and CNS-PFS by modified RECIST (mRECIST). The study enrolled 398 patients globally, including from sites in the United States, Europe and certain Asian countries including Japan and China. About Firmonertinib Firmonertinib is an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor active against both classical and uncommon EGFR mutations, including PACC and exon 20 insertion mutations. In March 2021, firmonertinib was approved in China for first-line advanced non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletion or L858R mutations and for patients with previously treated locally advanced or metastatic NSCLC with EGFR T790M mutation, otherwise known as EGFR classical mutations. Firmonertinib was granted U.S. Food and Drug Administrat...