LBL-024

LBL-024 Medication Report

Name: LBL-024 Name (English): LBL-024

Drug Type: Bispecific antibody

Target: PD-L1 and 4-1BB

Mechanism of Action: LBL-024 is a bispecific antibody that simultaneously targets Programmed Death Ligand-1 (PD-L1) and the co-stimulatory receptor 4-1BB (CD137). It blocks the PD-1/PD-L1 immunosuppressive pathway and selectively co-stimulates 4-1BB in the tumor microenvironment, enhancing T-cell activation and anti-tumor immune responses. Upon 4-1BB binding, LBL-024 acts as a conditional 4-1BB agonist in the tumor microenvironment (TME), resulting in T-cell co-stimulation and enhanced T-lymphocyte-mediated anti-tumor activity.

Therapeutic Areas: Neoplasms, Respiratory Diseases

Active Indication: Advanced Malignant Tumors, Neuroendocrine Carcinoma (EP-NEC), Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), Biliary Tract Cancer (BTC), Ovarian Cancer (OC), Esophageal Squamous Cell Carcinoma (ESCC).

R&D Status:

• Phase 2: Non-Small Cell Lung Cancer (China), Advanced Lung Non-Small Cell Carcinoma (China), Advanced Malignant Solid Neoplasm (China), Advanced Neuroendocrine Carcinoma (China), Advanced cancer (China).
• Pivotal Study (Phase IIb): Extrapulmonary Neuroendocrine Carcinomas (China).

Clinical Trial Information:

• NCT05170958: A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors.

Efficacy Data:

• In a Phase I/II study, LBL-024 demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC.
• At a dose of 15 mg/kg, the Objective Response Rate (ORR) was 37.5% and the Disease Control Rate (DCR) was 50.0% in second-line EP-NEC.
• An ORR of 54.5% was observed in patients with PD-L1 negative expression (CPS<1).
• In a Phase Ib/II trial combining LBL-024 with etoposide/platinum-based chemotherapy in treatment-naive advanced EP-NEC, encouraging efficacy was observed.