The Phase III FURVENT trial of furmonertinib to treat first-line NSCLC with EGFR exon 20 insertion mutations is enrolling subjects. Credit: create jobs 51 / Shutterstock.com.

ArriVent Biopharma has received the US Food and Drug Administration’s (FDA) breakthrough therapy designation for its new, oral, highly brain-penetrant furmonertinib to treat non-small cell lung cancer (NSCLC).

The treatment is intended for previously untreated patients with locally advanced or metastatic non-squamous NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

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The latest development is based on interim data from the Phase Ib FAVOUR clinical trial of furmonertinib. 

FAVOUR is an open-label, randomised, multicentre trial designed to analyse the safety and efficacy of furmonertinib for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. 

Furmonertinib provided encouraging anti-tumour activity as monotherapy with a well-tolerated safety profile in the first line, as well as in previously treated subjects.

The EGFR kinase inhibitor furmonertinib is being developed by ArriVent Biopharma globally and by Allist Pharmaceuticals in China.

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The Phase III FURVENT trial of furmonertinib to treat first-line NSCLC is currently enrolling subjects across the world.

ArriVent research and development co-founder and president Stuart Lutzker stated: “This FDA designation underscores the encouraging clinical activity we have seen with furmonertinib in the FAVOUR study and reflects the critical need for effective and tolerable therapeutic options for these patients. 

“We look forward to continuing our work with the agency as we progress our furmonertinib clinical development programme in NSCLC, including our ongoing pivotal, global Phase III FURVENT trial evaluating furmonertinib in previously untreated NSCLC patients whose tumours contain EGFR exon 20 insertion mutations.”