ADC landscape relevant to recurrent or metastatic nasopharyngeal carcinoma
| Study | Target/payload | Stage | Population/setting | Key data | Safety |
|---|---|---|---|---|---|
| BL-B01D1-303 (iza-bren)7 | EGFR × HER3/TOP1 inhibitor payload | Published randomised phase 3; approved in China | R/M NPC after at least 2 systemic lines including platinum and PD-1/PD-L1 inhibitor | ORR 54.6% vs. 27.0%; mPFS 8.38 vs. 4.34 months; median DoR 8.51 vs. 4.76 months | Grade ≥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)11 | EGFR/MMAE payload | Phase 2b; approved in China | Heavily pretreated R/M NPC vs. capecitabine or docetaxel | ORR 30.2% vs. 11.5%; mPFS 5.8 vs. 2.8 months; interim mOS 17.1 vs. 12.0 months | Grade ≥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 2a12 | EGFR/MMAE payload | Published, phase 2a | Previously treated R/M NPC, including patients after PD-1/PD-L1 and multiple chemotherapy lines | ORR 42%; median DoR 8.0 months; mPFS 5.8 months; mOS 15.8 months | Grade ≥3 TRAEs 39%; no treatment-related deaths reported |
| YL201 phase 1/1b NPC cohort14 | B7-H3/TOP1 inhibitor payload | Published, phase 1/1b | Heavily pretreated advanced solid tumours; NPC subgroup had prior anti-PD-L1 and platinum, and 84.3% had at least 2 prior systemic lines | ORR 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 payload | Recruiting, phase 3 | R/M NPC after prior PD-(L)1 inhibitor and at least 2 lines of chemotherapy | N/A | N/A |
| MRG003 + pucotenlimab (Magic-C002, NCT06976190) | EGFR ADC + PD-1 inhibitor | Recruiting, phase 3 | R/M NPC after prior standard therapy | N/A | N/A |
| MRG003 + pucotenlimab first-line study (NCT07381699) | EGFR ADC + PD-1 inhibitor | Not yet recruiting, phase 2 | First-line R/M NPC | N/A | N/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.