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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.

Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.

Authors :
Wang ZX
Cui C
Yao J
Zhang Y
Li M
Feng J
Yang S
Fan Y
Shi J
Zhang X
Shen L
Shu Y
Wang C
Dai T
Mao T
Chen L
Guo Z
Liu B
Pan H
Cang S
Jiang Y
Wang J
Ye M
Chen Z
Jiang D
Lin Q
Ren W
Wang J
Wu L
Xu Y
Miao Z
Sun M
Xie C
Liu Y
Wang Q
Zhao L
Li Q
Huang C
Jiang K
Yang K
Li D
Liu Y
Zhu Z
Chen R
Jia L
Li W
Liao W
Liu HX
Ma D
Ma J
Qin Y
Shi Z
Wei Q
Xiao K
Zhang Y
Zhang Y
Chen X
Dai G
He J
Li J
Li G
Liu Y
Liu Z
Yuan X
Zhang J
Fu Z
He Y
Ju F
Liu Z
Tang P
Wang T
Wang W
Zhang J
Luo X
Tang X
May R
Feng H
Yao S
Keegan P
Xu RH
Wang F
Source :
Cancer cell [Cancer Cell] 2022 Mar 14; Vol. 40 (3), pp. 277-288.e3. Date of Electronic Publication: 2022 Mar 03.
Publication Year :
2022

Abstract

Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43-0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile.<br />Competing Interests: Declaration of interests X.L. is employed by Shanghai Junshi Biosciences. X.T., H.F., and S. Yao are employed by Shanghai Junshi Biosciences and TopAlliance Biosciences. R.M. and P.K. are employed by TopAlliance Biosciences. R.-H.X. has served as a consulting or advisory role for Bristol-Myers Squibb, Merck Serono, Roche, Astellas, and AstraZeneca. All other authors have no competing interests.<br /> (Copyright © 2022 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1878-3686
Volume :
40
Issue :
3
Database :
MEDLINE
Journal :
Cancer cell
Publication Type :
Academic Journal
Accession number :
35245446
Full Text :
https://doi.org/10.1016/j.ccell.2022.02.007