(Esophageal Cancer) Is Serplulimab Plus Cisplatin Plus Fluorouracil Effective?
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- February 28, 2023
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On February 3, 2023, Yan Song and colleagues at the Chinese Academy of Medical Sciences and Peking Union Medical College published in the medical journal Nature Medicine the efficacy and safety results of a Phase 3 trial (NCT03958890) evaluating first-line serplulimab plus cisplatin plus fluorouracil in patients with PD-L1-positive locally advanced or metastatic esophageal squamous cell carcinoma.
Trial Design
This multicenter, double-blind Phase 3 trial enrolled 551 patients with PD-L1-positive locally advanced or metastatic esophageal squamous cell carcinoma, randomized to:
- Serplulimab (3 mg/kg Day 1) + cisplatin (50 mg/m² Day 1) + fluorouracil (1200 mg/m² Days 1–2) group: 2-week cycles (N=183)
- Placebo group: 2-week cycles
Primary endpoints: progression-free survival (PFS) and overall survival (OS). Secondary endpoints: objective response rate (ORR) and duration of response.
Efficacy Results
Median PFS:
- Serplulimab + cisplatin + fluorouracil group: 5.8 months / Placebo group: 5.3 months — significant improvement
Median OS:
- Serplulimab + cisplatin + fluorouracil group: 15.3 months / Placebo group: 11.8 months — significant improvement
Safety Profile
Grade 3 or higher adverse events:
- Serplulimab + cisplatin + fluorouracil group: 53% / Placebo group: 48%
Conclusions
Based on the Phase 3 trial results, Yan Song and colleagues concluded that first-line serplulimab plus cisplatin plus fluorouracil significantly improved both PFS and OS in patients with PD-L1-positive locally advanced or metastatic esophageal squamous cell carcinoma, with a manageable safety profile.
Source: https://www.nature.com/articles/s41591-022-02179-2#Sec6
- Clinical trial drug
- Immunotherapy
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