China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced receiving Investigational New Drug (IND) approval for its LB2102, an autologous chimeric antigen receptor-T (CAR-T) therapy designed to treat adult patients with small cell lung cancer (SCLC) by targeting DLL3, a cell surface protein highly expressed in SCLC.
Clinical Study Design
The open-label first-in-human Phase I study is designed to assess the safety and preliminary efficacy of LB2102 in patients with extensive-stage (ES-SCLC) or large cell neuroendocrine lung cancer (LCNEC). The study aims to determine the recommended Phase II dosage for the therapy.
Disease Context
Small cell lung cancer (SCLC) is the most aggressive form of lung cancer, accounting for 10% to 15% of lung cancer cases in the United States. Approximately 30,000 to 35,000 people are newly diagnosed with SCLC each year, with 60% to 70% of patients diagnosed with metastatic SCLC, which is particularly challenging to treat. The approval of LB2102 for clinical study represents a significant step forward in addressing this unmet medical need.-Fineline Info & Tech
