Legend Biotech Corporation has announced that the U.S. Food and Drug Administration (FDA) has cleared Legend Biotech’s investigational new drug (IND) application to proceed with the clinical development of LB2102, an investigational, autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC).
LB2102 is designed to selectively target delta-like ligand 3 (DLL-3), which is highly restricted to various malignancies, including SCLC, large cell neuroendocrine carcinoma (LCNEC), certain other neuroendocrine tumors and some prostate cancers. DLL-3 has also been linked to tumor growth, migration and invasion.
The phase 1, first-in-human, open-label clinical study is designed to evaluate the safety and preliminary efficacy of LB2102 in subjects with extensive stage SCLC and patients with LCNEC, as well as to determine the recommended dose for phase 2.
“Lung cancer is a debilitating disease that often spreads quickly. On average, only seven percent of patients with SCLC are alive five years after receiving their diagnosis,” said Lida Pacaud, vice-president of clinical development at Legend Biotech.
“We are eagerly awaiting the start of this phase 1 trial, and we hope that the study will provide much needed insight into the potential of this investigational CAR-T therapy.”
Small cell lung cancer
Lung cancer is a leading cause of cancer deaths, contributing to 25% of all cancer-related fatalities annually in the U.S. SCLC is the most aggressive, and accounts for roughly 10 to 15% of lung cancer cases in the U.S.
An estimated 30,000 to 35,000 people are diagnosed with the disease each year. The cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70% of SCLC patients are diagnosed with metastatic SCLC.
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, N.J., the company is developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.