Firmonertinib Phase 3 trial misses primary endpoint in First-Line EGFR Exon 20 Insertion Mutant NSCLC (ArriVent BioPharma)

Nasdaq: AVBP−48.74% 24h move
Price before$28.46Oct 5, 2026, 4:00 PM ET
First trade after$12.00Oct 6, 2026, 8:33 AM ET
24h later$14.59Oct 7, 2026, 7:55 AM ET

Complete Announced during: Premarket · announced Tue 8:07a ET (premarket); before = Mon close; first trade Tue 8:33a ET; time = SEC 8-K acceptance

ArriVent BioPharma (Nasdaq: AVBP) reported results from a Phase 3 trial of firmonertinib in First-Line EGFR exon 20 insertion mutant NSCLC on October 6, 2026. The company said the trial did not meet its primary endpoint. ClinicalTrials.gov lists 398 enrolled participants (NCT05607550).

Trial details

Drug
FirmonertinibType Drug Route oral
Treats
Studied as a treatment for First-Line EGFR exon 20 insertion mutant NSCLC (registry condition: Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations).Conditions Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations
Patients
398 patients (actual enrollment)3 arms · 208 sites in 19 countries
Phase
Phase 3
Design
Randomized, open-label, parallel-group
Primary endpoint
Progression Free Survival (PFS) determined by blinded independent central review (BICR) (Up to 32 months after first dose)
Key secondary endpoints
  • Overall Survival (OS)
  • PFS determined by investigator assessment
  • Overall response rate (ORR)
Result
Missed endpoint(Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that the FURVENT (NCT05607550) Phase 3 trial evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20…
Safety
The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified.
Sponsor
ArriVent BioPharma Nasdaq: AVBPCollaborator Allist Pharmaceuticals, Inc.
Dates
Study start Jun 1, 2023Primary completion Aug 15, 2025 (anticipated)Announced Oct 6, 2026, 8:07 AM ET (SEC 8-K filing time)
Trial ID
NCT05607550 ClinicalTrials.gov

About this trial

This randomized, open-label, parallel-group Phase 3 trial (NCT05607550) tested Firmonertinib in Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer and EGFR Exon 20 Mutations. Studied as a treatment for First-Line EGFR exon 20 insertion mutant NSCLC (registry condition: Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations). It enrolled 398 patients across 3 arms at 208 sites in 19 countries. The primary endpoint was Progression Free Survival (PFS) determined by blinded independent central review (BICR) (Up to 32 months after first dose). ArriVent BioPharma reported that the trial did not meet its primary endpoint. The study started on Jun 1, 2023 and is expected to reach primary completion on Aug 15, 2025. The lead sponsor is ArriVent BioPharma, with Allist Pharmaceuticals, Inc. as a collaborator.

Sources

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