Tab. 1 Teil 2: 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

Zweitlinie

Nivolumab

PD-1

ATTRACTION- 3

Kato et al.

18

419

4 %/96 %

100 %/0 %

Nivo vs. Pacli/Doce

PD-L1-unabhängig

OS (HR 0,77; 95%-KI 0,62–0,96)

ja

 

 

 

 

 

 

 

 

 

TPS ≥ 1 %

OS (HR 0,69; 95%-KI 0,51–0,94)

 

 

 

 

 

 

 

 

 

TPS < 1 %

OS (HR 0,84; 95%-KI 0,62–1,14)

Pembrolizumab

PD-1

KN-181

Kojima et al.

19

628

 62 %/38 %

64 %/36 %

Pembro vs. Pacli/Doce/Irino

PD-L1-unabhängig

OS (HR 0,89; 95%-KI 0,75–1,05)

 

 

 

 

 

 

 

 

 

 

CPS ≥ 10 (AEG + PEC)

OS (HR 0,69; 95%-KI 0,52–0,93)

 

 

 

 

 

 

 

 

 

 

CPS < 10 (AEG + PEC)

OS (HR 1,00; 95%-KI 0,81–1,24)

 

 

 

 

 

 

 

 

 

 

Gesamt PEC

OS (HR 0,78; 95%-KI 0,63–0,96)

 

 

 

 

 

 

 

 

 

 

CPS ≥ 10

OS (HR 0,64; 95%-KI 0,6–0,90)

 

Tislelizumab

PD-1

RATIONALE- 302

Shen et al.

20

512

21 %/97 %

100 %/0 %

Tisle vs. Doce/Pacli/Irino

PD-L1-unabhängig

OS (HR 0,70; 95%-KI 0,57–0,85)

 

 

 

 

 

 

 

 

 

 

CPS ≥ 10

OS (HR 0,53; 95%-KI 0,37–0,77)

 

 

 

 

 

 

 

 

 

 

CPS < 10 

OS (HR 0,85;95%-KI 0,65–1,11)

 

Camrelizumab

PD-1

ESCORT

Huang et al.

21

457

0 %/100 %

100 %/0 %

Camre vs. Doce/Irino

PD-L1-unabhängig

OS (HR 0,71; 95%-KI 0,57–0,87)

 

 

 

 

 

 

 

 

 

 

TPS ≥ 1 %

OS (HR 0,58; 95%-KI 0,42–0,81)

 

 

 

 

 

 

 

 

 

 

TPS < 1 %

OS (HR 0,82; 95%-KI 0,62–1,09)

 

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.