ArriVent BioPharma Reports Phase 3 FURVENT Trial Missed Primary Endpoint in NSCLC

Key highlights

• Primary endpoint of progression-free survival (PFS) by blinded independent central review was not met
• Firmonertinib 240mg dose achieved a median PFS of 11.0 months compared to 9.5 months for the control arm
• Study recorded a p-value of 0.0654 for the 240mg dose, failing to reach the threshold for statistical significance
• Confirmed objective response rate for the 240mg cohort was 60% versus 33% for the chemotherapy control
• Treatment-related adverse events of Grade 3 or higher were 26% for the 240mg dose and 40% for the control group
• Trend toward improvement in overall survival was observed although the data remains immature

Phase 3 FURVENT Trial Outcomes

ArriVent BioPharma released top-line data from the FURVENT Phase 3 trial, which compared firmonertinib monotherapy at 160 mg and 240 mg doses to platinum-based chemotherapy. The trial involved 398 patients globally with untreated, locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations. The primary endpoint, progression-free survival as determined by blinded independent central review, was not met. Specifically, the 240mg dose cohort reached a median PFS of 11.0 months with a hazard ratio of 0.75, while the control group showed 9.5 months. The 160mg dose achieved a median PFS of 8.4 months.

Secondary Endpoints and Safety Profile

Despite missing the primary metric, firmonertinib demonstrated clinical benefit across several secondary endpoints. Investigator assessments recorded a median PFS of 11.1 months for the 240mg dose compared to 7.1 months for the control arm. The drug also showed a significantly higher confirmed objective response rate of 60% at the higher dose level. Safety data remained consistent with previous clinical experience; treatment-related adverse events of Grade 3 or higher occurred in 26% of patients in the 240mg group and 22% in the 160mg group, which was lower than the 40% reported in the chemotherapy control arm.

Corporate and Pipeline Strategy

• Company is evaluating the full FURVENT dataset to identify the most appropriate regulatory and development path
• Firmonertinib continues to be studied in the global pivotal Phase 3 ALPACCA trial for EGFR PACC mutant NSCLC
• ArriVent maintains a licensing agreement with Shanghai Allist Pharmaceuticals for the development of firmonertinib
• Pipeline includes ARR-002, a novel tetravalent ADC targeting MUC16 and NaPi2b, which cleared IND in May 2026
• Dosing of the first patient in the Phase 1 clinical trial of ARR-002 is targeted for the second half of 2026

Financial Position and Outlook

ArriVent enters this period of clinical re-evaluation with a substantial liquidity buffer. As of mid-2026, the company reported cash, cash equivalents, and short-term investments totaling approximately $373.1 million. Management has previously projected that these resources will be sufficient to fund planned operations and clinical developments into 2028. This capital runway allows the company to support its broader oncology pipeline, including its antibody-drug conjugate programs and ongoing trials in different lung cancer mutations, while it determines the next steps for its lead candidate in the exon 20 insertion mutant patient population.

Down 43.5% since our story on 6 Oct: $28.46 when we broke it → $16.09 at the close on 13 Oct. Daily closing prices. Source: Yahoo Finance.

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Management Perspective

“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.”

Management commentary

“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.”

ArriVent BioPharma, Inc. · financial snapshot

Share price	$28.46
Market cap	$1.4B
1-month price change	-6.72%
Sector	HealthcareBiotechnology

Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.