By Fineline Cube 
China-based Lepu Biopharma Co., Ltd (HKG: 2157) announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase II clinical study for its MRG003 combined with pucotenlimab versus MRG003 alone in locally advanced head and neck squamous cell carcinoma (HNSCC). Patient enrollment is expected to begin in Q3 2025.
Clinical Trial Significance
This study represents the world’s first clinical trial evaluating an EGFR-targeted antibody-drug conjugate (ADC) in combination with a PD-1 inhibitor for locally advanced HNSCC. The Phase II trial will focus on patients with locally advanced disease, investigating the efficacy and safety of MRG003 as a monotherapy or in combination with immunotherapy prior to first-line treatment for advanced cases.
Drug Mechanism
MRG003 is an ADC composed of an EGFR-targeting monoclonal antibody conjugated to the potent microtubule inhibitor MMAE via a vc linker. It specifically binds with high affinity to EGFR-expressing tumor cells, undergoes internalization, and releases the cytotoxic payload to induce tumor cell death.-Fineline Info & Tech