ArriVent BioPharma Inc. (AVBP) had a rough Tuesday. The clinical-stage biopharma's stock got hammered after its Phase 3 FURVENT trial for firmonertinib missed its primary endpoint. Shares were down 49.07% at $14.49 at the time of publication, a new 52-week low, according to market data. Volume exploded to 14.10 million shares, compared to the average of just 524,163. That's a 27-fold spike, in case you're counting.
The trial tested firmonertinib as a standalone therapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer. Specifically, it targeted those with EGFR exon 20 insertion mutations. The goal was progression-free survival, and the drug didn't hit it. Simple as that.
Secondary Endpoints Show Clinical Benefit
But here's where it gets interesting. While the primary endpoint missed, firmonertinib did show clinical advantages across secondary endpoints. Investigators recorded noticeable improvements in progression-free survival based on their own assessments. And the blinded independent central review confirmed a strong objective response rate. There was also an encouraging trend toward enhanced overall survival, though the data still need to mature.
Detailed FURVENT Trial Efficacy Data
Let's dig into the numbers. Patients on the 240mg dose had a median progression-free survival of 11.0 months by blinded review, narrowly beating the 9.5 months in the control group. The lower 160mg dose gave an 8.4-month median. Under investigator assessment, the separation was clearer: 11.1 months for the 240mg dose versus just 7.1 months for the control arm.
The confirmed objective response rate by blinded review hit 60% for the 240mg group and 35% for the 160mg group. The control arm managed 33%. So the high dose clearly did something, even if it wasn't enough to satisfy the primary endpoint.
Firmonertinib Safety and Tolerability Profile
On the safety side, no new signals emerged. The profile aligned closely with previous studies. Grade 3 or higher treatment-emergent adverse events occurred in 52% of the 240mg cohort and 53% of the 160mg cohort, both slightly lower than the 55% rate in the control arm. For treatment-related adverse events of Grade 3 or higher, the numbers were 26% for the 240mg group and 22% for the 160mg group, notably better than the 40% in 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 market data.
