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Becotatug vedotin + PD-1 inhibitor is a combination therapy developed by Lepu Biopharma, primarily for the treatment of EGFR-positive advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC). The combination consists of **becotatug vedotin** (MRG003), an antibody-drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), and a **PD-1 inhibitor**, most specifically **pucotenlimab** (HX008). Becotatug vedotin utilizes a humanized anti-EGFR monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable valine-citrulline linker. Pucotenlimab is a humanized IgG4 monoclonal antibody that blocks the PD-1 receptor to restore anti-tumor immune responses. This combination has demonstrated significant clinical activity, with objective response rates (ORR) of 60% in HNSCC and 73.3% in heavily pretreated NPC patients who had failed prior immunotherapy and platinum-based therapy. While becotatug vedotin received its first regulatory approval in China in October 2025 for recurrent/metastatic NPC as a monotherapy, the combination is currently undergoing Phase 2 and Phase 3 clinical trials to establish its efficacy as a first-line or later-line treatment.
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