Lepu Biotech has launched a Phase III trial for its TF-targeting ADC MRG004A in pancreatic cancer, following promising Phase I/II data presented in 2024. In the study, MRG004A demonstrated a 33.3% objective response rate (ORR) and 83.3% disease control rate (DCR) in 12 evaluable pancreatic cancer patients at 2.0 mg/kg dosing. The ADC also showed activity in triple-negative breast cancer (25% ORR) and cervical cancer (1 partial response among 2 patients), with manageable safety including grade 3 conjunctivitis (35%) and anaemia (17%) events.

MRG004A uses site-specific conjugation technology to enhance stability, targeting TF overexpression linked to thrombosis and metastasis in solid tumours. The Phase III trial will further evaluate efficacy in TF-high pancreatic cancer patients.

Lepu is advancing the candidate as part of its broader ADC pipeline, which includes collaborations with Excalipoint Therapeutics for T-cell engagers.

PharmCube's NextBiopharm® database lists 101 ADC active projects in pancreatic cancer, including 10 that successfully cleared the clinic. Click here to request a free trial for NextBiopharm®.