NEWTOWN SQUARE, PA — ArriVent BioPharma has dosed the first patient in a global Phase 3 study that could reshape first-line treatment for a small but hard-to-treat group of lung cancer patients.
The pivotal ALPACCA trial is evaluating firmonertinib as a once-daily oral monotherapy for patients with EGFR PACC mutant non-small cell lung cancer, a subset with limited approved options and historically poor outcomes. The study pits firmonertinib against existing targeted therapies in a randomized, global design intended to support both accelerated and full regulatory approvals.
Firmonertinib is designed to be broadly active across uncommon EGFR mutations and to penetrate the brain, a key limitation of many current therapies. If successful, the drug could offer a chemo-free alternative for patients who often face rapid disease progression and few effective first-line choices.
“Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib,” said ArriVent Chairman and Chief Executive Officer Bing Yao. He said patients with EGFR PACC mutations represent a clear unmet medical need and argued that the drug’s clinical profile positions it to become a cornerstone therapy across the EGFR-mutant spectrum.
PACC mutations account for roughly 12 percent of EGFR mutations in non-small cell lung cancer and are distinct from both classical mutations and exon 20 insertions. There is no broadly accepted standard of care for first-line treatment in this population, leaving physicians to rely on therapies developed for other mutation types with mixed results.
The ALPACCA study, also known as FURMO-006, is testing firmonertinib at a 240-milligram daily dose against investigator-selected osimertinib or afatinib. Primary endpoints include overall response rate and progression-free survival, both assessed by blinded independent central review. The selected dose is based on earlier trial data showing a median progression-free survival of 16 months and a confirmed overall response rate of 68 percent.
ArriVent estimates the annual incidence of EGFR PACC mutant non-small cell lung cancer at roughly 42,000 patients globally outside China, including about 6,200 in the United States, making the market modest in size but clinically significant given the lack of effective options.
The trial is part of a broader development strategy for firmonertinib, which is already approved in China for certain classical EGFR mutations and has received U.S. regulatory designations aimed at speeding development in other mutation subtypes. Additional late-stage studies are underway in exon 20 insertion mutations, another area of high unmet need.
For ArriVent, a clinical-stage biopharmaceutical company, the ALPACCA trial represents a defining test of its lead asset. For patients with EGFR PACC mutant lung cancer, it may determine whether a long-standing treatment gap can finally be closed.
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