Lepu Gains World's First EGFR ADC Approval for Nasopharyngeal Cancer in China

Lepu Biopharma has received China National Medical Products Administration (NMPA) approval for becotatug vedotinas, marking the first global EGFR-targeting antibody-drug conjugate (ADC) approval, in this case for recurrent or metastatic nasopharyngeal cancer (NPC) following failure of at least two systemic chemotherapy lines and PD-1/L1 inhibitor therapy. The candidate utilises a valine-citrulline linker conjugating a monoclonal antibody (mAb) to a MMAE payload, demonstrating 30.2% objective response rate (ORR) versus 11.5% for chemotherapy in a Phase II trial, with median progression-free survival (mPFS) improvement of 5.82 months versus 2.83 months and 37% risk reduction. The approval addresses an unmet need in nasopharyngeal cancer where 89% of advanced cases express EGFR, with limited treatment options after standard therapy failure. Lepu is exploring combination with PD-1 inhibitor pucotenlimab, and expansion into head and neck squamous cell carcinoma indications. PharmCube's NextBiopharm® database identifies four additional EGFR ADCs in clinical development, including candidates from CSPC Pharma, Bliss Biopharma, DAC Biotech and Henlius Biotech.

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