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splatin 75 mg/m2 IV on Day 1 Q3W (n = 545) Gemcitabine 1250 mg/m2 IV on Days 1, 8 + Cisplatin 75 mg/m2 IV on Day 1 Q3W (n = 548) Maximum 6 cycles Pts without PD receiving necitumumab could continue on singleagent necitumumab until PD or unacceptable toxicity PD 第四頁,共十四頁。 P = .02) Median PFS, Mos (95% CI) () () 3Mo PFS, % (95% CI) 79 (7683) 73 (6876) 6Mo PFS, % (95% CI) 45 (4049) 37 (3342) N + G/C (n = 545) G/C (n = 548) 0 20 40 60 80 100 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 Mos PFS (%) N + G/C Censored pts G/C Censored pts 第七頁,共十四頁。 Conclusions and Faculty Assessment ? Necitumumab addition to gemcitabine/cisplatin conferred significant survival benefit to chemotherapynaive pts with stage IV squamous NSCLC vs gemcitabine/cisplatin alone – Median OS: vs mos (P = .01) – Median PFS: vs mos (P = .02) ? Grade ≥ 3 and serious AEs more mon with necitumumab + gemcitabine/cisplatin vs gemcitabine/cisplatin (72% vs 62% and 48% vs 38%, respectively) ? Necitumumab plus gemcitabine/cisplatin approved by FDA for firstline treatment of patients with metastatic squamous NSCLC Slide credit: Thatcher N, et al. Lancet Oncol. 2024。 (N = 1093)。 P = .01)。 Conclusions and Faculty Assessment ? EGFR expression not predictive/prognostic of necitumumab benefit ? Weaknesses of this study: – Dichotomous categorization of EGFR expression into high vs low groups may have reduced ability to detect efficacy differences – Interpretation of subgroup analyses limited by size of subgroups ? Future directions: – Explore benefit of continued necitumumab use following treatment with necitumumab + platinum