Table 1

ADC landscape relevant to recurrent or metastatic nasopharyngeal carcinoma

StudyTarget/payloadStagePopulation/settingKey dataSafety
BL-B01D1-303 (iza-bren)7EGFR × HER3/TOP1 inhibitor payloadPublished randomised phase 3; approved in ChinaR/M NPC after at least 2 systemic lines including platinum and PD-1/PD-L1 inhibitorORR 54.6% vs. 27.0%; mPFS 8.38 vs. 4.34 months; median DoR 8.51 vs. 4.76 monthsGrade ≥3 TRAEs 80%; common grade ≥3 events were hematologic (anemia 50%, decrease in WBCs 43%, decrease in platelet count 43%, decrease in neutrophil count 38%); 4 treatment-related deaths
MRG003 randomised trial (Magic-M001)11EGFR/MMAE payloadPhase 2b; approved in ChinaHeavily pretreated R/M NPC vs. capecitabine or docetaxelORR 30.2% vs. 11.5%; mPFS 5.8 vs. 2.8 months; interim mOS 17.1 vs. 12.0 monthsGrade ≥3 TRAEs 45.3% (decrease in WBC count 9.3%, decrease in neutrophil count 9.3%, hyponatremia 9.3%); 3 deaths due to AEs reported
MRG003 phase 2a12EGFR/MMAE payloadPublished, phase 2aPreviously treated R/M NPC, including patients after PD-1/PD-L1 and multiple chemotherapy linesORR 42%; median DoR 8.0 months; mPFS 5.8 months; mOS 15.8 monthsGrade ≥3 TRAEs 39%; no treatment-related deaths reported
YL201 phase 1/1b NPC cohort14B7-H3/TOP1 inhibitor payloadPublished, phase 1/1bHeavily pretreated advanced solid tumours; NPC subgroup had prior anti-PD-L1 and platinum, and 84.3% had at least 2 prior systemic linesORR 48.6%; DCR 92.9%Overall study grade ≥3 TRAEs included a decrease in neutrophil count (31.7%), decrease in WBC count (29.5%), and anemia (25.0%)
YL201 (NCT06629597)B7-H3/TOP1 inhibitor payloadRecruiting, phase 3R/M NPC after prior PD-(L)1 inhibitor and at least 2 lines of chemotherapyN/AN/A
MRG003 + pucotenlimab (Magic-C002, NCT06976190)EGFR ADC + PD-1 inhibitorRecruiting, phase 3R/M NPC after prior standard therapyN/AN/A
MRG003 + pucotenlimab first-line study (NCT07381699)EGFR ADC + PD-1 inhibitorNot yet recruiting, phase 2First-line R/M NPCN/AN/A

ADC, antibody–drug conjugate; DCR, disease control rate; DoR, duration of response; MMAE, monomethyl auristatin E; NPC, nasopharyngeal carcinoma; ORR, objective response rate; mOS, median overall survival; mPFS, median progression-free survival; R/M, recurrent or metastatic; TRAE, treatment-related adverse event; AE, adverse event; WBC, white blood cell; N/A, not applicable.