Legend Biotech’s small cell lung cancer drug has received FDA approval

Legend Biotech Corporation announced that the US Food and Drug Administration (FDA) has granted Legend Biotech an Investigational New Drug (IND) application to continue clinical development of LB2102, an investigational autologous T-cell receptor chimeric antigen (CAR-T) therapy for the treatment of adult patients with advanced stage small cell lung cancer cancer (SCLC).

LB2102 is designed to selectively target delta-like ligand 3 (DLL-3), which is highly restricted in a variety of malignancies, including SCLC, large cell neuroendocrine carcinoma (LCNEC), certain other neuroendocrine tumors, and certain types of prostate cancer. DLL-3 has also been associated with tumor growth, migration, and invasion.

The Phase 1, first-in-human, open-label clinical trial is designed to evaluate the safety and preliminary efficacy of LB2102 in subjects with extensive-stage SCLC and patients with LCNEC, and 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 diagnosis,” said Lida Paco, vice president of clinical development at Legend Biotech.

“We look forward to the start of this Phase 1 trial and 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 the leading cause of cancer death, contributing to 25% of all cancer-related deaths in the US each year. SCLC is the most aggressive and accounts for approximately 10 to 15% of lung cancers in the US

According to estimates, 30,000 to 35,000 people are diagnosed with this disease every year. Cancer becomes more difficult to treat when it has spread and progressed to the advanced stage of SCLC. Approximately 60-70% of patients with MCL are diagnosed with metastatic MCL.

About Legend Biotech

Legend Biotech is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. Headquartered in Somerset, NJ, the company develops advanced cell therapies across a variety of technology platforms, including autologous and allogeneic chimeric antigen receptor T cell and natural killer (NK) cell-based immunotherapy.