ArriVent to Present Firmonertinib Phase 1b Data at 2024 Lung Cancer Conference

ArriVent BioPharma, Inc., a clinical-stage company focused on advancing innovative biopharmaceutical therapeutics, has announced that it will present interim data from its randomized Phase 1b FURTHER study at the 2024 World Conference on Lung Cancer (WCLC). The study investigates the efficacy of firmonertinib as a first-line monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR PACC mutations. This presentation will occur during the Presidential Symposium on September 9, 2024, in San Diego, California.

Firmonertinib, an oral EGFR inhibitor, is highly brain-penetrant and effective against a range of EGFR mutations, including both classical and uncommon variants like PACC and exon 20 insertion mutations. This drug was approved in China in March 2021 for treating advanced NSCLC with EGFR exon 19 deletion or L858R mutations, as well as for patients with previously treated, locally advanced, or metastatic NSCLC harboring EGFR T790M mutations. Additionally, the U.S. FDA has granted firmonertinib Breakthrough Therapy and Orphan Drug Designations for treating NSCLC patients with specific EGFR mutations, including exon 20 insertions.

ArriVent's FURTHER study is a pivotal global, randomized trial assessing firmonertinib at two dosage levels in TKI-naïve, advanced NSCLC patients with EGFR PACC mutations. The presentation at the WCLC will provide the first prospectively designed randomized clinical data for a small-molecule EGFR tyrosine kinase inhibitor in this patient population. This data underscores the potential of firmonertinib as a significant treatment option for NSCLC patients with these uncommon EGFR mutations.

ArriVent is also conducting a global Phase 3 trial (FURVENT) to evaluate firmonertinib in first-line NSCLC patients with EGFR exon 20 insertion mutations. Furthermore, a clinical combination study is underway in partnership with Beijing InnoCare Pharma Tech Co., Ltd., targeting advanced or metastatic NSCLC patients with classical EGFR mutations.

NSCLC is the most common subtype of lung cancer, representing around 85% of all lung cancer cases globally. Mutational activation of the EGFR is a significant factor in the development of NSCLC, with mutations divided into classical and uncommon categories. Among these, EGFR exon 20 insertion mutations account for about 9% of all EGFR mutations, while PACC mutations represent approximately 12%. Patients with tumors harboring these uncommon EGFR mutations generally face a lower life expectancy with currently available treatments, highlighting an urgent unmet medical need.

ArriVent's mission is to address these needs by leveraging its extensive drug development expertise to maximize the potential of firmonertinib and other novel therapeutics. The company's pipeline includes next-generation antibody drug conjugates aimed at advancing through approval and commercialization stages.

The presentation of the FURTHER study results at the WCLC marks a significant milestone for ArriVent and its efforts to advance the treatment options for NSCLC patients with EGFR mutations. The firm is also organizing a virtual webinar on September 9, 2024, at 4:30 pm ET to discuss the firmonertinib program in more detail.

ArriVent remains committed to developing and commercializing differentiated medicines to meet the critical needs of cancer patients, continually pushing the boundaries of current treatment paradigms to improve patient outcomes.