Arrivent Biopharma said its Phase 3 Furvent trial of firmonertinib in first-line EGFR exon 20 insertion mutant non-small cell lung cancer missed its primary endpoint, with blinded independent central review showing median progression-free survival of 11.0 months for the 240 mg dose and 8.4 months for the 160 mg dose versus 9.5 months for chemotherapy.
The 240 mg arm posted a hazard ratio of 0.75 and a p-value of 0.0654 versus control, while the 160 mg arm had a hazard ratio of 0.91. By investigator assessment, median progression-free survival was 11.1 months for 240 mg and 8.3 months for 160 mg, compared with 7.1 months for control, with hazard ratios of 0.61 and 0.86, respectively.
Confirmed objective response rates by blinded independent central review were 60% for 240 mg, 35% for 160 mg, and 33% for control. By investigator assessment, confirmed objective response rates were 61% for 240 mg, 41% for 160 mg, and 28% for control.
The safety profile was broadly in line with earlier studies. Grade 3 or higher treatment-emergent adverse events occurred in 52% of patients on 240 mg, 53% on 160 mg, and 55% in the control arm. Grade 3 or higher treatment-related adverse events were 26% with 240 mg, 22% with 160 mg, and 40% with control.
The study enrolled 398 patients globally. The market has reacted to these announcements by moving the company's shares 0.67% to a price of $28.46. For the full picture, make sure to review ArriVent BioPharma's 8-K report.
