Junshi Biosciences gets FDA nod for JS207 lung cancer study

Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug application for a phase II/III clinical study of JS207. This open-label, two-arm, randomized, active-controlled, international multi-center study will evaluate JS207 for the neoadjuvant treatment of patients with stage II/III, resectable, actionable genomic aberration-negative non-small cell lung cancer (NSCLC).

JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by the company, designed to simultaneously bind to PD-1 and VEGFA. This dual-action mechanism aims to block PD-1 binding to PD-L1/PD-L2 and VEGF binding to its receptor, offering both immunotherapeutic and anti-angiogenic properties. The study compares JS207 against nivolumab, marking the first PD-1/VEGF dual-target drug approved for a confirmatory study in surgically eligible patients.

Lung cancer remains a leading cause of cancer-related mortality globally, with NSCLC accounting for approximately 85% of cases. JS207 seeks to address unmet needs in patient survival and cure rates for resectable NSCLC.