Tab. 1 Teil 1: Studienübersicht aktueller Phase-III-Studien zur Immuntherapie des Ösophaguskarzinoms [Quelle: Autor:innen].
Therapielinie | Wirkstoff | Target | Studie | Autor | Ref # | n (Pat) | n (Nicht-Asien/Asien) | n (PEC/AEG) | Studiendesign | PD-L1-Score | Ergebnisse (primärer Endpunkt) | Zulassung Europa |
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Adjuvanz | Nivolumab | PD-1 | CM -577 | Kelly et al. | 10 | 794 | 85 %/15 % | 30 %/70 % | Adjuvant Nivo vs. Placebo | PD-L1-unabhängig | DFS (HR 0,69; 96,4%-KI 0,56–0,86) | ja |
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| TPS ≥ 1 % | DFS (HR 0,75; 95%-KI 0,45–1,24) | ||
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| TPS < 1 % | DFS (HR 0,73; 95%-KI 0,57–0,92) | ||
Erstlinie | Pembrolizumab | PD-1 | KN -590 | Sun et al. | 12 | 749 | 48 %/51 % | 73 %/27 % | Pembro vs. Placebo + FP | Gesamt PEC + AEG | OS (HR 0,73; 95%-KI 0,62–0,86) | ja (CPS ≥ 10) |
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| Gesamt PEC | OS (HR 0,72; 95%-KI 0,60–0,88) | ||
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| CPS ≥ 10 PEC | OS (HR 0,57; 95%-KI 0,43–0,75) | ||
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| CPS < 10 PEC | OS (HR 0,99; 95%-KI 0,74–1,32) | ||
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| CPS ≥ 10 AEG | OS (HR 0,83; 95%-KI 0,52–1,34) | ||
Nivolumab | PD-1 | CM- 648 | Chau et al. | 13 | 970 | 30 %/70 % | 100 %/0 % | Nivo + Cis/5-FU vs. Cis/5-FU | PD-L1-unabhängig | OS (HR 0,74; 99,1%-KI 0,58–0,96) | ja, Nivo + FP (TPS ≥ 1 %) | |
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| TPS ≥ 1 % | OS (HR 0,54; 99,5%-KI 0,37–0,80) | ||
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| TPS < 1 % | OS (HR 0,98) | ||
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| Nivo + Ipi vs. Cis/5-FU | PD-L1-unabhängig | OS (HR 0,78; 98,2%-KI 0,62–0,98) | ja, Nivo + Ipi (TPS ≥ 1 %) | |
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| TPS ≥ 1 % | OS (HR 0,64; 98,6%-KI 0,46–0,90) | ||
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| TPS < 1 % | OS (HR 0,96) | ||
Tislelizumab | PD-1 | RATIONALE- 306 | Yoon et al. | 14 | 649 | 25 %/75 % | 100 %/0 % | Tisle + Platin/FP oder Platin/Pacli vs. Chemo | PD-L1-unabhängig | OS (HR 0,66; 95%-KI 0,54–0,80) |
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| PD-L1 > 10 % | OS (HR 0,62; 95%-KI 0,44–0,86) |
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Camrelizumab | PD-1 | ESCORT-1 | Luo et al. | 15 | 596 | 0 %/100 % | 100 %/0 % | Camre + Cis/Pacli vs. Cis/Pacli | PD-L1-unabhängig | OS (HR 0,70; 95%-KI 0,56–0,88) |
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| TPS ≥ 1 % | OS (HR 0,59; 95%-KI 0,43–0,80) |
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| TPS < 1 % | OS (HR 0,79; 95%-KI 0,57–1,11) |
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Sintilimab | PD-1 | ORIENT-15 | Shen et al. | 16 | 659 | 0 %/100 % | 100 %/0 % | Sinti + Chemo (Cis/5-FU or Cis/Pacli) vs. Chemo | PD-L1-unabhängig | OS (HR 0,63; 95%-KI 0,51–0,78) |
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| CPS ≥ 10 | OS (HR 0,64; 95%-KI 0,48–0,85) |
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| CPS < 10 | OS (HR 0,62; 95%-KI 0,45–0,85) |
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Toripalimab | PD-1 | JUPITER-06 | Xu et al. | 17 | 659 | 0 %/100 % | 100 %/0 % | Tori + Cis/Pacli vs. Cis/Pacli | PD-L1-unabhängig | OS (HR 0,58; 95%-KI 0,43–0,78) |
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| CPS ≥ 10 | OS (HR 0,61; 95%-KI 0,44–0,87) |
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| CPS < 10 | OS (HR 0,61; 95%-KI 0,30–1,25) |
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PEC: Plattenepithelkarzinom; AEG: Adenokarzinom des gastroösophagealen Übergangs; Nivo: Nivolumab; Ipi: Ipilimumab; Tisle: Tislelizumab; Camre: Camrelizumab; Sinti: Sintilimab; Tori: Toripalimab; Cis: Cisplatin; Chemo: Chemotherapie; 5-FU: 5-Fluoro-uracil; FP: Fluoropyrimidin; Doce: Docetaxel; Irino: Irinotecan; KN: KEYNOTE; CM = CheckMate; PD-1: „programmed cell death protein-1 “; PD L1: „programmed cell death ligand-1 “, CPS: „combined positive score“; TPS: „tumor proportion score“;
HR: Hazard Ratio; KI: Konfidenzintervall.