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.
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.
Photo by Komsan Loonprom via Shutterstock
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