ArriVent BioPharma Lung Cancer Drug Fails Primary Trial Endpoint, Stock Hits 52-Week Low

ArriVent BioPharma Inc. (NASDAQ:AVBP) stock fell on Tuesday with a session volume of 14.10 million compared to the average volume of 524.163 thousand, according to Benzinga Pro data. The company announced that its Phase 3 FURVENT trial evaluating firmonertinib failed to achieve its primary endpoint. The clinical-stage biopharmaceutical company tested the drug as a standalone therapy for patients suffering from previously untreated, locally advanced, or metastatic non-squamous non-small cell lung cancer. Specifically, the study targeted patients harboring EGFR exon 20 insertion mutations. Ultimately, the trial missed the primary progression-free survival target. Secondary Endpoints Show Clinical Benefit Despite missing the principal metric, firmonertinib demonstrated clinical advantages across secondary endpoints. Evaluators recorded noticeable improvements in progression-free survival based on direct investigator assessments. Furthermore, the blinded independent central review confirmed a strong objective response rate for the experimental therapy. While the data require further maturation, researchers observed an encouraging trend toward enhanced overall survival among treated patients. Read Also: Merck, Daiichi Sankyo Scrap FDA Application for Lung Cancer Drug Detailed FURVENT Trial Efficacy Data Patients receiving the 240mg dose of firmonertinib posted a median progression-free survival of 11.0 months by blinded review, narrowly edging out the 9.5 months observed in the control group. The lower 160mg dose yielded an 8.4-month median. Under investigator assessment, the data showed clearer separation. The 240mg dose achieved an 11.1-month median progression-free survival compared to just 7.1 months for the control arm. The confirmed objective response rate by blinded review reached a robust 60% for the 240mg group and 35% for the 160mg group. In contrast, the control arm managed a 33% confirmed objective response rate. Firmonertinib Safety and Tolerability Profile The FURVENT study revealed no new safety signals, and the safety profile aligned closely with previous clinical evaluations of firmonertinib. Grade 3 or higher treatment-emergent adverse events occurred in 52% of the 240mg cohort and 53% of the 160mg cohort. Both treatment groups experienced slightly fewer events than the control arm, which reported a 55% rate. Additionally, Grade 3 or higher treatment-related adverse events affected 26% of the 240mg group and 22% of the 160mg group. These figures represent a notable improvement over the 40% rate documented within the control arm. AVBP Price Action: ArriVent BioPharma shares were down 49.07% at $14.49 at the time of publication on Tuesday. The stock is trading at a new 52-week low, according to Benzinga Pro data. Read Also: Tesla Rival Lucid Cuts Production Output by 38%, Misses Delivery Estimates Despite High Fuel Costs Leading to EV Surge Photo by Komsan Loonprom via Shutterstock