The IND clearance comes after Legend terminated another clinical trial in T-cell lymphoma in July 2022.
The FDA has cleared Legend Biotech’s investigational new drug application (IND) for LB2102, a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with extensive stage small cell lung cancer (SCLC).1
“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,” Lida Pacaud, MD, vice president, clinical development, Legend Biotech, said in a statement.1 “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.”
Legend Biotech will soon initiate a phase 1, first-in-human, clinical trial to evaluate preliminary efficacy and safety of LB2102. The study will enroll patients with extensive stage SCLC as well as large cell neuroendocrine carcinoma and will seek to determine the recommended phase 2 dose of the therapy.
LB2102 is an autologous CAR T-cell therapy selectively targeted toward delta-like ligand 3 (DLL-3). DLL-3 is highly restricted to expression in malignancies including SCLC and LCNEC as well as some prostate cancers and neuroendocrine tumors. As shown in previous studies, the target is also linked to tumor growth, invasion, and migration.
Most recently, in July 2022, Legend Biotech revealed in an SEC filing that it had terminated its phase 1 clinical trial for LB1901, an investigational autologous anti-CD4+ CAR T-cell therapy for the treatment of adults with relapsed/refractory T-cell lymphoma (R/R TCL).2 The company stated that it had decided to prioritize other candidates in its pipeline with the termination, which was partially based on the lack of clinical benefit seen in an investigator-initiated study conducted in China on a similar Legend Biotech CAR T-cell therapy candidate which expresses the same CAR protein as LB1901.
The trial (NCT04712864) was an open-label, multicenter, first-in-human study with a target enrollment of 50 adult participants with histologically confirmed CD4+ R/R peripheral T-cell lymphoma (PTCL) or R/R cutaneous (TCL)who had previously been treated with at least 2 prior lines of systemic antineoplastic therapy. On May 25, 2022, just 6 weeks prior to the termination, the FDA lifted a clinical hold placed on February 11, 2022. The hold was placed after Legend voluntarily paused the trial due to a case of low CD4+ T-cell counts in the peripheral blood of the only patient who had been dosed at that time. As of February 2022, the patient had not experienced drug-related serious adverse events and was being monitored in accordance with protocol.