Risvutatug rezetecan (B7-H3 TOP1i ADC) + adebrelimab (PD-L1) posts 47% cORR and 11.2-mo mPFS in 2L+ nsq-NSCLC

Risvutatug rezetecan (Ris-Rez; HS-20093/GSK5764227) is a B7-H3–targeted antibody-drug conjugate delivering a topoisomerase-1 inhibitor payload, combined here with adebrelimab, an anti–PD-L1 monoclonal antibody, in ARTEMIS-101 Phase 1 (open-label; dose escalation/expansion; NCT06332170) in previously treated advanced non-squamous NSCLC without actionable genomic alterations. As of Oct 20, 2025, 40 patients were treated (34 efficacy-evaluable) after prior platinum chemo (100%), immunotherapy (75%), and antiangiogenic therapy (45%); confirmed ORR was 47.1% (DCR 94.1%), 9-month DoR rate 90.0%, and mPFS 11.2 months (95% CI: 11.2–NR), including activity in PD-L1 TPS<1 (cORR 33.3%; mPFS 11.2 months) and TPS≥1 (cORR 62.5%; mPFS immature). For context, common post-platinum benchmarks like docetaxel alone deliver ~12% ORR and mPFS ~2–4 months, while docetaxel+ramucirumab improves OS modestly vs docetaxel (REVEL) and typically does not approach double-digit mPFS—so the 11.2-month mPFS here stands out for a 2L+ population, albeit in a small Phase 1 single-arm subset. Grade ≥3 TEAEs ≥20% were myelosuppression-heavy (WBC ↓30%, lymphocytes ↓30%, neutrophils ↓30%, anemia 25%); TEAEs led to dose reduction in 20.0% and discontinuation in 7.5%, with no TEAE-related deaths reported.