ArriVent BioPharma has begun its global Phase 3 ALPACCA study by dosing the first patient with firmonertinib, a third‑generation EGFR inhibitor, in patients who carry EGFR PACC‑mutations. The trial is designed to compare 240 mg of firmonertinib once daily with investigator‑chosen osimertinib or afatinib, the current standard options for this rare mutation.
EGFR PACC‑mutations account for roughly 12 % of all EGFR‑mutant non‑small‑cell lung cancers, representing about 42,000 patients worldwide and 6,200 in the United States each year. No approved targeted therapy exists for this group, so the ALPACCA trial addresses a clear unmet medical need and could open a new therapeutic niche for ArriVent.
The study will enroll approximately 600 patients across 200 sites worldwide, with enrollment expected to complete by the fourth quarter of 2026. The trial’s global reach and sizable patient cohort are intended to generate robust efficacy and safety data that can support accelerated and full regulatory submissions, positioning firmonertinib as a potential cornerstone therapy for the broader EGFR‑mutant spectrum.
CEO Bing Yao emphasized the drug’s safety profile and its demonstrated activity in both systemic and central nervous system disease, noting that firmonertinib’s brain‑penetrant properties could give it an advantage over existing options. He also acknowledged potential headwinds, including competition from other EGFR inhibitors, the challenge of enrolling a rare patient population, and the need to navigate regulatory pathways in multiple jurisdictions.
ArriVent’s financial position supports the continuation of late‑stage development: the company reports more cash than debt and liquid assets that exceed short‑term obligations, giving it the runway to fund the ALPACCA trial through 2026 and beyond. The first‑patient milestone therefore not only de‑risks the clinical program but also strengthens the company’s ability to pursue future growth opportunities in the oncology space.
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