Key insights
- ArriVent BioPharma's stock plummeted 63% after its Phase 3 FURVENT trial for firmonertinib in first-line EGFR exon 20 insertion mutant non-small cell lung cancer failed to meet its primary endpoint of progression-free survival. While secondary endpoints showed some clinical benefit, the drug did not demonstrate a statistically significant improvement over chemotherapy, leading to a substantial stock price decline.
Investing.com -- ArriVent BioPharma (NASDAQ:AVBP) shares fell 63% Tuesday after the company announced its Phase 3 FURVENT trial of firmonertinib in first-line EGFR exon 20 insertion mutant non-small cell lung cancer failed to meet its primary endpoint.
The trial, which evaluated firmonertinib monotherapy in patients with previously untreated, locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 20 insertion mutations, did not achieve its primary endpoint of progression free survival by blinded independent central review. The study compared firmonertinib at 160 mg and 240 mg doses against platinum-based chemotherapy with pemetrexed.
According to the results, 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 240 mg dose versus control was 0.0654, failing to reach statistical significance. The hazard ratio for the 240 mg dose versus control was 0.75.
Clinical benefit was observed with secondary endpoints including PFS by investigator’s assessment and confirmed objective response rate by BICR. The confirmed objective response rate by BICR was 60% for the 240 mg dose, 35% for the 160 mg dose, and 33% for the control arm. Although not yet mature, a trend toward an improvement in overall survival was also observed.
"These disappointing results are not what we hoped for, particularly for the patients with EGFR exon 20 insertion-mutant NSCLC who urgently need more effective treatment options," commented Bing Yao, Chairman and Chief Executive Officer of ArriVent. "While the safety profile observed with firmonertinib was consistent with previous clinical studies, FURVENT did not show a meaningful improvement in PFS over chemotherapy by BICR in this study."
The safety profile observed in FURVENT was consistent with previous clinical studies of firmonertinib, with no new safety signals identified. The FURVENT trial enrolled 398 patients globally.
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