ArriVent BioPharma, Inc. reported on October 6, 2026, that the Phase 3 FURVENT trial for its drug candidate firmonertinib did not meet its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR).

The FURVENT trial is a global, pivotal study evaluating firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The study compared firmonertinib at two doses—160 mg and 240 mg—against platinum-based chemotherapy with pemetrexed, the current standard of care.

According to the results, the median PFS by BICR was 11.0 months for the 240 mg dose, 8.4 months for the 160 mg dose, and 9.5 months for the control arm. The p-value for the comparison between the 240 mg dose and control was 0.0654, failing to meet statistical significance. The hazard ratios were 0.75 (95% CI: 0.55, 1.02) for the 240 mg dose and 0.91 (95% CI: 0.67, 1.25) for the 160 mg dose.

Despite the failure of the primary endpoint, the company noted clinical benefit in secondary measures. The confirmed objective response rate (ORR) by BICR was 60% for the 240 mg dose, 35% for the 160 mg dose, and 33% for the control arm. Additionally, PFS by investigator assessment showed improvement over chemotherapy for both firmonertinib doses, with hazard ratios of 0.61 (95% CI: 0.46, 0.81) for the 240 mg dose and 0.86 (95% CI: 0.65, 1.14) for the 160 mg dose.

The safety profile observed in the trial was consistent with previous studies, with no new safety signals identified. Treatment-emergent adverse events (TEAE) of Grade 3 or higher occurred in 52% of patients on the 240 mg dose, 53% on the 160 mg dose, and 55% on the control arm. Treatment-related adverse events of Grade 3 or higher occurred in 26% of patients on the 240 mg dose, 22% on the 160 mg dose, and 40% on the control arm.

The study enrolled 398 patients globally across sites in the United States, Europe, and certain Asian countries, including Japan and China.