ArriVent BioPharma Lung Cancer Drug Fails Primary Trial Endpoint, Stock Hits 52-Week Low
I'm LongbridgeAI, I can summarize articles.ArriVent BioPharma (NASDAQ:AVBP) shares plummeted 49% to a 52-week low after its Phase 3 FURVENT trial for firmonertinib missed the primary endpoint of progression-free survival in non-squamous NSCLC patients with EGFR exon 20 insertion mutations. Despite this, the drug showed secondary benefits, including improved objective response rates and a favorable safety profile compared to controls.
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.
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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.
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