FDA Grants Fast Track Designation to PD-1/VEGF Bispecific Antibody in NSCLC
核心洞察
The FDA has granted fast track designation to cesalatamig (搜索) (AI-081), an investigational PD-1 (搜索)/VEGF (搜索) bispecific antibody, for previously treated non-small cell lung cancer (搜索).
The designation covers NSCLC that has progressed after PD-(L)1-targeted immunotherapy and platinum-based chemotherapy, a setting with limited treatment options.
OncoC4 (搜索) said the agent is being evaluated in the global phase 1/2 BiPAVE-001 trials in the US and China and is advancing toward registrational phase 3 development.
The FDA has granted fast track designation to cesalatamig (搜索) (AI-081), an investigational PD-1 (搜索)/VEGF (搜索) bispecific antibody, for patients with non-small cell lung cancer (搜索) (NSCLC) whose disease has progressed following concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy, according to developer OncoC4 (搜索). The designation is intended to support expedited development in a setting with limited treatment options.
Cesalatamig (搜索) is being evaluated in the global phase 1/2 BiPAVE-001 trials in the US (NCT06635785) and China (CTR20253261). Part A is a phase 1 dose-escalation and dose-expansion study, and Part B comprises phase 2 dose-optimization cohorts testing the agent as monotherapy or in combination with standard-of-care or novel agents. The trials are running at more than 50 sites across the US and China, with most patients enrolled in the US. Primary end points are maximum tolerated dose and dose-limiting toxicities; secondary end points include peak serum concentration after intravenous infusion and serum half-life.
The antibody has high affinity for PD-1 (搜索) and more than 40-fold higher affinity for VEGF (搜索) than bevacizumab-based bispecific PD-(L)1/VEGF inhibitors, a profile the company says favors activity in a PD-1- and VEGF-rich tumor microenvironment. Cesalatamig (搜索) also carries Fc-silencing modifications designed to avoid depletion of PD-1-positive effector T cells. OncoC4 (搜索), based in Rockville, Maryland, wholly owns the agent and said it is advancing it toward registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications.
Source: CancerNetwork