ArriVent reports 16-month PFS for lung cancer drug firmonertinib

NEWTOWN SQUARE - ArriVent BioPharma, Inc. (NASDAQ:AVBP), a clinical-stage biotech company with a market capitalization of $820 million, announced positive final proof-of-concept data from its Phase 1b FURTHER trial evaluating firmonertinib in first-line treatment of non-small cell lung cancer (NSCLC) with EGFR PACC mutations. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 12.74, indicating robust short-term financial stability.

The data, presented at the World Conference on Lung Cancer in Barcelona, showed a median progression-free survival of 16.0 months with once-daily 240 mg firmonertinib as assessed by blinded independent central review. Patients receiving this dose demonstrated a confirmed overall response rate of 68.2% with a median duration of response of 14.6 months. While the clinical results appear promising, InvestingPro analysis indicates the company is currently trading above its Fair Value, with analysts setting price targets ranging from $33 to $45.

The oral therapy also showed activity against brain metastases, with a 42.9% confirmed central nervous system response rate, including complete responses in 35.7% of CNS-evaluable patients.

"Our 16-month prolonged progression free survival with once daily oral firmonertinib monotherapy has been maintained with 16.5 months of median follow up," said Bing Yao, Chairman and CEO of ArriVent.

The drug demonstrated rapid clearance of circulating tumor DNA in 82% of patients at the 240 mg dose and 79% at the 160 mg dose across various PACC mutation types.

The safety profile remained consistent with the EGFR-TKI drug class, with common treatment-related adverse events including diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin.

ArriVent expects to enroll the first patient in its global Phase 3 ALPACCA study for first-line EGFR PACC mutant NSCLC in the second half of 2025.

Firmonertinib previously received FDA Breakthrough Therapy Designation for treating previously untreated locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations, and Orphan Drug Designation for NSCLC with EGFR, HER2, or HER4 mutations.

According to the press release statement, PACC mutations represent approximately 12% of all EGFR mutations in NSCLC, and patients with these mutations currently have limited treatment options. Despite current losses with earnings per share at -$4.02, InvestingPro data reveals the company holds more cash than debt, positioning it well for continued clinical development. Subscribers to InvestingPro can access 5 additional key insights about ArriVent’s financial health and growth prospects.

In other recent news, ArriVent BioPharma announced that top-line results from its pivotal Phase 3 FURVENT study of firmonertinib in first-line EGFR Exon20 insertion-positive non-small cell lung cancer (NSCLC) are expected in early 2026. The company completed enrollment for the trial in the first quarter of 2025, with 398 patients recruited across the United States, Europe, and parts of Asia, including Japan and China. H.C. Wainwright raised its price target on ArriVent BioPharma to $42.00 from $40.00, maintaining a Buy rating, citing the upcoming trial results as a major catalyst. Oppenheimer reiterated its Outperform rating with a price target of $44.00, noting the revised timeline for the trial results. Goldman Sachs resumed coverage with a Buy rating and a price target of $33.00, expressing confidence in the trial’s potential to demonstrate competitive clinical efficacy. These developments highlight the anticipation surrounding the FURVENT trial outcomes.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.