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Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Authors
 Ronan J. Kelly  ;  Jeeyun Lee  ;  Yung-Jue Bang  ;  Khaldoun Almhanna  ;  Mariela Blum-Murphy  ;  Daniel V.T. Catenacci  ;  Hyun Cheol Chung  ;  Zev A. Wainberg  ;  Michael K. Gibson  ;  Keun-Wook Lee  ;  Johanna C. Bendell  ;  Crystal S. Denlinger  ;  Cheng Ean Chee  ;  Takeshi Omori  ;  Rom Leidner  ;  Heinz-Josef Lenz  ;  Yee Chao  ;  Marlon C. Rebelatto  ;  Philip Z. Brohawn  ;  Peng He  ;  Jennifer McDevitt  ;  Siddharth Sheth  ;  Judson M. Englert  ;  Geoffrey Y. Ku 
Citation
 CLINICAL CANCER RESEARCH, Vol.26(4) : 846-854, 2020 
Journal Title
 CLINICAL CANCER RESEARCH 
ISSN
 1078-0432 
Issue Date
2020
Abstract
PURPOSE: This randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer. PATIENTS AND METHODS: Second-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months. RESULTS: A total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively. CONCLUSIONS: Response rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population.
Files in This Item:
T202000753.pdf Download
DOI
10.1158/1078-0432.CCR-19-2443
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/175571
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