NEWTOWN SQUARE, PA — ArriVent BioPharma, Inc. (Nasdaq: AVBP) announced it expects topline data in early 2026 from its global Phase 3 FURVENT trial evaluating firmonertinib as a first-line treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations—a patient population with few effective options and limited survival outcomes.
The study completed enrollment in Q1 2025 with 398 patients across North America, Europe, and Asia. The trial compares once-daily doses of firmonertinib (160 mg or 240 mg) against platinum-based chemotherapy with pemetrexed, the current standard of care. The primary endpoint is progression-free survival (PFS) as measured by independent central review under RECIST 1.1 criteria. Secondary measures include central nervous system-specific response and PFS for patients with brain metastases at baseline.
Global Push for a Targeted Option
The FURVENT trial is being conducted in partnership with Allist Pharmaceuticals and is a key part of ArriVent’s broader strategy to bring targeted therapies to underserved NSCLC patient segments. Firmonertinib is already approved in China for certain classical EGFR mutations and previously treated T790M-positive NSCLC.
Unlike common EGFR mutations, exon 20 insertions represent an uncommon and more treatment-resistant form, making up roughly 9% of all EGFR mutations. Patients with these mutations often respond poorly to conventional therapies, and available treatments offer only modest improvements in survival.
Firmonertinib has already received Breakthrough Therapy Designation and Orphan Drug Designation from the U.S. FDA, reflecting its potential to address a serious unmet need. The drug is designed to be highly brain-penetrant and mutation-selective, offering potential benefits to patients with central nervous system involvement—common in advanced NSCLC.
Expanding the Pipeline
Beyond FURVENT, firmonertinib is also being evaluated in ALPACCA, another global Phase 3 study targeting PACC mutations, another uncommon EGFR subgroup. Additional trials are underway for combination therapies targeting classical EGFR mutations in collaboration with Beijing InnoCare Pharma.
Addressing a Major Global Burden
NSCLC accounts for around 85% of lung cancer cases, which remains the leading cause of cancer death worldwide. While targeted therapies have advanced outcomes for patients with classical EGFR mutations, those with rare mutations like exon 20 insertions and PACC variants continue to face limited options.
ArriVent is aiming to change that by building a late-stage pipeline centered on precision oncology. With firmonertinib now in pivotal trials globally, the company is positioning itself to enter a market segment where demand for novel, mutation-specific treatments continues to grow.
Topline results from the FURVENT trial will be closely watched as ArriVent pushes toward a potential regulatory submission. If successful, firmonertinib could provide a new first-line standard for a subset of NSCLC patients long underserved by existing therapies.
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