Nivolumab in Patients with Advanced Platinum-resistant Urothelial Carcinoma: Efficacy, Safety, and Biomarker Analyses with Extended Follow-up from CheckMate 275.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Matthew D GalskyPadmanee Sharma

Abstract

We report efficacy and safety with extended follow-up, and exploratory biomarker analyses from the phase II CheckMate 275 trial to identify biomarkers of response to nivolumab in platinum-resistant metastatic or unresectable urothelial carcinoma (mUC). Patients received nivolumab 3 mg/kg once every 2 weeks until disease progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was objective response rate (ORR) per blinded independent review committee (BIRC; using RECIST v1.1) in all treated patients and by tumor PD-L1 expression. Key secondary endpoints were progression-free survival (PFS) per BIRC using RECIST v1.1 and overall survival (OS) in all patients and by PD-L1 expression. Exploratory endpoints included safety and biomarker analyses of tumor mutational burden (TMB), PD-L1, and previously identified mutational signatures. Of 270 treated patients, 139 had evaluable TMB. With 33.7 months' minimum follow-up, ORR per BIRC, median PFS, and median OS [95% confidence interval (CI)] in all treated patients were 20.7% (16.1-26.1), 1.9 months (1.9-2.3), and 8.6 months (6.1-11.3), respectively. No new safety signals were identified. Higher TMB was associated (P < 0.05) with improved ORR [OR (95% C...Continue Reading

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Citations

Aug 28, 2020·Frontiers in Cell and Developmental Biology·Xue-Jiao HanXia-Wei Wei
Aug 3, 2020·Journal of Translational Medicine·Jiaping LiYanhong Deng
Oct 7, 2020·International Journal of Molecular Sciences·Olga Bednova, Jeffrey V Leyton
Aug 8, 2020·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Umang SwamiNeeraj Agarwal
Nov 4, 2020·Cancer Discovery·Dan ShaFrank A Sinicrope
Feb 12, 2021·Journal of Controlled Release : Official Journal of the Controlled Release Society·Jaehyun KimYong-Hee Kim
Feb 20, 2021·Seminars in Cancer Biology·Ionut-Gabriel FuninganaJames D Brenton
Mar 8, 2021·The AAPS Journal·Julianne D Twomey, Baolin Zhang
Mar 13, 2021·Targeted Oncology·Enrique GrandeAndrea Necchi
Apr 6, 2021·Current Opinion in Oncology·Alexander Y Andreev-DrakhlinJianjun Gao
Apr 28, 2021·Expert Opinion on Pharmacotherapy·Ariana L SantopietroJoaquim Bellmunt
May 8, 2021·Hematology/oncology Clinics of North America·Rosa NadalJoaquim Bellmunt
May 8, 2021·Hematology/oncology Clinics of North America·Guru P Sonpavde
Apr 11, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Li WangMatthew D Galsky

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