Pennsylvania-based ArriVent BioPharma (Nasdaq: AVBP) reported that the Phase III FURVENT trial of firmonertinib in previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations did not meet its primary blinded independent central review (BICR)-assessed PFS endpoint despite a stronger investigator-assessed efficacy signal.
The global, three-arm FURVENT trial (NCT05607550) enrolled 398 patients and compared firmonertinib at 160 mg or 240 mg once daily with platinum-based chemotherapy plus pemetrexed. Median PFS by BICR was 11.0 months with firmonertinib 240 mg, 8.4 months with 160 mg, and 9.5 months with chemotherapy, corresponding to hazard ratios of 0.75 (95% CI 0.55–1.02; p=0.0654) and 0.91 (95% CI 0.67–1.25), respectively. Confirmed objective response rates by BICR were 60%, 35%, and 33%.
Investigator assessment showed a stronger efficacy signal than the independent central review, with median PFS of 11.1 months with firmonertinib 240 mg, 8.3 months with 160 mg, and 7.1 months with chemotherapy. The 240 mg dose produced a hazard ratio of 0.61 (95% CI 0.46–0.81) versus control by investigator assessment, compared with 0.75 by BICR. ArriVent said overall survival data were not yet mature but showed a trend toward improvement.
Grade ≥3 treatment-related adverse events occurred in 26% of patients receiving firmonertinib 240 mg, 22% receiving firmonertinib 160 mg, and 40% in the control arm. ArriVent said no new safety signals were identified.
Firmonertinib, a third-generation EGFR tyrosine kinase inhibitor developed by Shanghai Allist Pharmaceuticals and licensed to ArriVent in 2021 for development and commercialization outside Greater China, holds US FDA Breakthrough Therapy Designation for previously untreated non-squamous NSCLC with EGFR exon 20 insertion mutations. The drug is already approved and commercially available in China for first-line classical EGFR-mutant NSCLC, while Allist received NMPA accelerated approval in February 2026 for second-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations following progression on, or intolerance to, platinum-based chemotherapy.