复发性鼻咽癌治疗新突破：MRG003的ORR与PFS分析

Discuss the finalized ORR and PFS efficacy endpoints of this study, highlighting its clinical significance. Previous studies exploring third-line or later treatment for recurrent/metastatic nasopharyngeal carcinoma (NPC) have primarily included patients who failed chemotherapy, which creates a gap with the current landscape where first-line treatment is predominantly immunotherapy. For patients with recurrent/metastatic NPC who have failed both immunotherapy and chemotherapy, third-line and beyond treatment options are very limited. To our knowledge, this is the first multicenter, randomized controlled trial conducted in patients with recurrent/metastatic NPC who have received at least two lines of systemic therapy and have failed PD-1/PD-L1 inhibitor treatment. It is also the first RCT to validate the efficacy and safety of EGFR-ADC in solid tumors. In this study, compared to monotherapy chemotherapy, MRG003 significantly improved ORR and prolonged PFS, providing a treatment option for heavily treated NPC patients who have previously received immunotherapy. The EGFR-ADC monotherapy used in this study may have certain advantages over combination strategies explored in previous studies, such as immunotherapy combined with EGFR-TKIs (e.g., camrelizumab plus famitinib [17]) or dual immunotherapy (e.g., Anti-LAG-3 antibody LBL-007 plus toripalimab [18]).