ArriVent BioPharma Reports Positive Phase 1b Trial Results for Lung Cancer Drug Firmonertinib
ArriVent BioPharma, Inc. (AVBP) announced the publication of Phase 1b clinical study results evaluating its investigational drug firmonertinib in patients with EGFR PACC-mutant non-small cell lung cancer. Among front-line patients receiving a 240 mg daily dose, the treatment achieved a confirmed overall response rate of 68% and a median progression-free survival of 16.0 months, compared to a 43% response rate and 11.1 months of survival for those on a 160 mg dose.
The therapy also demonstrated activity in the central nervous system, recording a 47% confirmed intracranial overall response rate in patients with brain metastases, with 41% achieving complete responses. In addition, 80% of evaluable patients showed early clearance of circulating tumor DNA by the third treatment cycle, which strongly correlated with higher response rates and longer progression-free survival. Safety outcomes remained manageable and aligned with earlier trials.
Investors will be monitoring the next stage of development as ArriVent BioPharma, Inc. advances firmonertinib into its global Phase 3 ALPACCA trial to evaluate the treatment in a larger patient population.
Key points
- A 240 mg dose of firmonertinib achieved a 68% response rate and 16.0 months median progression-free survival in front-line lung cancer patients.
- Brain metastasis patients showed a 47% intracranial response rate, with 41% achieving a complete response.
- Early circulating tumor DNA clearance occurred in 80% of evaluable patients, correlating with improved survival metrics.
- ArriVent BioPharma, Inc. is advancing the therapy into a global Phase 3 clinical study called ALPACCA.
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What were the key Phase 1b trial results for firmonertinib?
In front-line lung cancer patients, firmonertinib achieved a 68% response rate and 16.0 months progression-free survival at a 240 mg dose, along with strong tumor DNA clearance.
Did ArriVent BioPharma's drug show effectiveness against brain metastases?
Yes, firmonertinib demonstrated a 47% confirmed intracranial response rate in patients with brain metastases, including complete responses in 41% of cases.
What is the next step for ArriVent BioPharma's firmonertinib trial?
ArriVent BioPharma, Inc. is progressing the treatment into a global Phase 3 clinical study known as ALPACCA.
