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

Cited 22 time in Web of Science Cited 20 time in Scopus
Authors
Kelly, Ronan J.; Lee, Jeeyun; Bang, Yung-Jue; Almhanna, Khaldoun; Blum-Murphy, Mariela; Catenacci, Daniel V. T.; Hyun Cheol Chung; Wainberg, Zev A.; Gibson, Michael K.; Lee, Keun-Wook; Bendell, Johanna C.; Denlinger, Crystal S.; Chee, Cheng Ean; Omori, Takeshi; Leidner, Rom; Lenz, Heinz-Josef; Chao, Yee; Rebelatto, Marlon C.; Brohawn, Philip Z.; He, Peng; McDevitt, Jennifer; Sheth, Siddharth; Englert, Judson M.; Ku, Geoffrey Y.
Issue Date
2020-02
Citation
Clinical Cancer Research, Vol.26 No.4, pp.846-854
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 IFN gamma 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 IFNg 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.
ISSN
1078-0432
URI
https://hdl.handle.net/10371/173049
DOI
https://doi.org/10.1158/1078-0432.CCR-19-2443
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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