NEWTOWN SQUARE, PA – ArriVent BioPharma, Inc. (Nasdaq: AVBP) presented final proof-of-concept results from its global Phase 1b FURTHER trial of firmonertinib, an oral targeted therapy for patients with non-small cell lung cancer (NSCLC) carrying rare EGFR PACC mutations, at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer in Barcelona.
The data showed firmonertinib delivered a median progression-free survival of 16 months in patients who received the 240 mg dose, with most participants remaining on treatment. Progression-free survival refers to the length of time a patient lives without the disease worsening. Median duration of response reached nearly 15 months, and confirmed response rates were 68 percent at the higher dose and 44 percent at 160 mg. Notably, patients with brain metastases responded strongly: six of 14 saw their tumors shrink, and five achieved complete disappearance of brain lesions.
“We are particularly encouraged by the CNS responses, including complete responses,” said Bing Yao, Ph.D., ArriVent’s chairman and chief executive officer. “This data reinforces the potential of firmonertinib to address key unmet needs in the EGFR mutant NSCLC treatment landscape. We expect to enroll the first patient in our global registrational ALPACCA Phase 3 trial later this year.”
The safety profile of firmonertinib remained consistent with earlier findings and with other EGFR inhibitors, showing manageable side effects such as diarrhea, skin rash, and elevated liver enzymes. No new safety concerns emerged with longer follow-up.
The study also tracked circulating tumor DNA (ctDNA), fragments of cancer DNA found in the blood that provide clues about tumor activity. More than 80 percent of patients had rapid clearance of ctDNA, suggesting firmonertinib’s effectiveness across a wide range of uncommon PACC mutations.
Firmonertinib, first approved in China in 2021 for certain common EGFR mutations, is engineered to penetrate the brain and block a broad spectrum of genetic alterations. It has received Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration for specific subsets of NSCLC patients.
Globally, lung cancer remains the leading cause of cancer deaths, and NSCLC accounts for about 85 percent of cases. Mutations in the epidermal growth factor receptor (EGFR) gene drive many of these cancers. While therapies exist for the more common mutations, patients with exon 20 insertions and PACC mutations—together representing more than 20 percent of EGFR-positive NSCLC—have few effective treatment options.
ArriVent is currently advancing firmonertinib in two global Phase 3 trials: the FURVENT study for exon 20 insertion mutations and the ALPACCA study for PACC mutations. Both aim to establish the drug as a frontline alternative to chemotherapy, with topline results from FURVENT expected in 2026.
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