Literature DB >> 32532789

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

Abdel Saci1, Matthew D Galsky2, Peter M Szabo1, G Celine Han1, Gary Grossfeld1, Sandra Collette1, Arlene Siefker-Radtke3, Andrea Necchi4, Padmanee Sharma3.   

Abstract

PURPOSE: 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 AND METHODS: 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.
RESULTS: 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% CI): 2.13 (1.26-3.60)], PFS [HR: 0.75 (0.61-0.92)], and OS [HR: 0.73 (0.58-0.91)]. TMB combined with PD-L1 better predicted ORR, PFS, and OS than PD-L1 alone. Higher mutational signature 2 score was associated with better OS but did not improve the predictive value of TMB.
CONCLUSIONS: These results support the durable antitumor activity of nivolumab and suggest that TMB may enrich for better response in mUC. Future studies of TMB/PD-L1 as biomarkers for response to nivolumab in randomized trials are warranted.See related commentary by Swami et al., p. 5059. ©2020 American Association for Cancer Research.

Entities:  

Year:  2020        PMID： 32532789      PMCID： PMC8166422          DOI： 10.1158/1078-0432.CCR-19-4162

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  21 in total

1.  Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden.

Authors:  Matthew D Hellmann; Tudor-Eliade Ciuleanu; Adam Pluzanski; Jong Seok Lee; Gregory A Otterson; Clarisse Audigier-Valette; Elisa Minenza; Helena Linardou; Sjaak Burgers; Pamela Salman; Hossein Borghaei; Suresh S Ramalingam; Julie Brahmer; Martin Reck; Kenneth J O'Byrne; William J Geese; George Green; Han Chang; Joseph Szustakowski; Prabhu Bhagavatheeswaran; Diane Healey; Yali Fu; Faith Nathan; Luis Paz-Ares
Journal:  N Engl J Med       Date:  2018-04-16       Impact factor: 91.245

2.  Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial.

Authors:  Padmanee Sharma; Margitta Retz; Arlene Siefker-Radtke; Ari Baron; Andrea Necchi; Jens Bedke; Elizabeth R Plimack; Daniel Vaena; Marc-Oliver Grimm; Sergio Bracarda; José Ángel Arranz; Sumanta Pal; Chikara Ohyama; Abdel Saci; Xiaotao Qu; Alexandre Lambert; Suba Krishnan; Alex Azrilevich; Matthew D Galsky
Journal:  Lancet Oncol       Date:  2017-01-26       Impact factor: 41.316

3.  Tumor and Microenvironment Evolution during Immunotherapy with Nivolumab.

Authors:  Nadeem Riaz; Jonathan J Havel; Vladimir Makarov; Alexis Desrichard; Walter J Urba; Jennifer S Sims; F Stephen Hodi; Salvador Martín-Algarra; Rajarsi Mandal; William H Sharfman; Shailender Bhatia; Wen-Jen Hwu; Thomas F Gajewski; Craig L Slingluff; Diego Chowell; Sviatoslav M Kendall; Han Chang; Rachna Shah; Fengshen Kuo; Luc G T Morris; John-William Sidhom; Jonathan P Schneck; Christine E Horak; Nils Weinhold; Timothy A Chan
Journal:  Cell       Date:  2017-10-12       Impact factor: 41.582

Review 4.  The Cancer Immunogram as a Framework for Personalized Immunotherapy in Urothelial Cancer.

Authors:  Nick van Dijk; Samuel A Funt; Christian U Blank; Thomas Powles; Jonathan E Rosenberg; Michiel S van der Heijden
Journal:  Eur Urol       Date:  2018-09-28       Impact factor: 20.096

5.  Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial.

Authors:  Thomas Powles; Ignacio Durán; Michiel S van der Heijden; Yohann Loriot; Nicholas J Vogelzang; Ugo De Giorgi; Stéphane Oudard; Margitta M Retz; Daniel Castellano; Aristotelis Bamias; Aude Fléchon; Gwenaëlle Gravis; Syed Hussain; Toshimi Takano; Ning Leng; Edward E Kadel; Romain Banchereau; Priti S Hegde; Sanjeev Mariathasan; Na Cui; Xiaodong Shen; Christina L Derleth; Marjorie C Green; Alain Ravaud
Journal:  Lancet       Date:  2017-12-18       Impact factor: 79.321

6.  COSMIC: somatic cancer genetics at high-resolution.

Authors:  Simon A Forbes; David Beare; Harry Boutselakis; Sally Bamford; Nidhi Bindal; John Tate; Charlotte G Cole; Sari Ward; Elisabeth Dawson; Laura Ponting; Raymund Stefancsik; Bhavana Harsha; Chai Yin Kok; Mingming Jia; Harry Jubb; Zbyslaw Sondka; Sam Thompson; Tisham De; Peter J Campbell
Journal:  Nucleic Acids Res       Date:  2016-11-28       Impact factor: 16.971

7.  Implementing TMB measurement in clinical practice: considerations on assay requirements.

Authors:  Reinhard Büttner; John W Longshore; Fernando López-Ríos; Sabine Merkelbach-Bruse; Nicola Normanno; Etienne Rouleau; Frédérique Penault-Llorca
Journal:  ESMO Open       Date:  2019-01-24

8.  The immune response-related mutational signatures and driver genes in non-small-cell lung cancer.

Authors:  Hao Chen; Wei Chong; Changcai Teng; Yueliang Yao; Xin Wang; Xue Li
Journal:  Cancer Sci       Date:  2019-07-23       Impact factor: 6.716

9.  Signatures of mutational processes in human cancer.

Authors:  Ludmil B Alexandrov; Serena Nik-Zainal; David C Wedge; Samuel A J R Aparicio; Sam Behjati; Andrew V Biankin; Graham R Bignell; Niccolò Bolli; Ake Borg; Anne-Lise Børresen-Dale; Sandrine Boyault; Birgit Burkhardt; Adam P Butler; Carlos Caldas; Helen R Davies; Christine Desmedt; Roland Eils; Jórunn Erla Eyfjörd; John A Foekens; Mel Greaves; Fumie Hosoda; Barbara Hutter; Tomislav Ilicic; Sandrine Imbeaud; Marcin Imielinski; Marcin Imielinsk; Natalie Jäger; David T W Jones; David Jones; Stian Knappskog; Marcel Kool; Sunil R Lakhani; Carlos López-Otín; Sancha Martin; Nikhil C Munshi; Hiromi Nakamura; Paul A Northcott; Marina Pajic; Elli Papaemmanuil; Angelo Paradiso; John V Pearson; Xose S Puente; Keiran Raine; Manasa Ramakrishna; Andrea L Richardson; Julia Richter; Philip Rosenstiel; Matthias Schlesner; Ton N Schumacher; Paul N Span; Jon W Teague; Yasushi Totoki; Andrew N J Tutt; Rafael Valdés-Mas; Marit M van Buuren; Laura van 't Veer; Anne Vincent-Salomon; Nicola Waddell; Lucy R Yates; Jessica Zucman-Rossi; P Andrew Futreal; Ultan McDermott; Peter Lichter; Matthew Meyerson; Sean M Grimmond; Reiner Siebert; Elías Campo; Tatsuhiro Shibata; Stefan M Pfister; Peter J Campbell; Michael R Stratton
Journal:  Nature       Date:  2013-08-14       Impact factor: 49.962

Review 10.  Tumor mutational burden standardization initiatives: Recommendations for consistent tumor mutational burden assessment in clinical samples to guide immunotherapy treatment decisions.

Authors:  Albrecht Stenzinger; Jeffrey D Allen; Jörg Maas; Mark D Stewart; Diana M Merino; Madison M Wempe; Manfred Dietel
Journal:  Genes Chromosomes Cancer       Date:  2019-03-07       Impact factor: 5.006
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  20 in total

Review 1.  Coming of Age of Immunotherapy of Urothelial Cancer.

Authors:  Enrique Grande; Javier Molina-Cerrillo; Andrea Necchi
Journal:  Target Oncol       Date:  2021-03-12       Impact factor: 4.493

Review 2.  Evolution of predictive and prognostic biomarkers in the treatment of advanced gastric cancer.

Authors:  Nicole M Myer; Kohei Shitara; Hyun C Chung; Florian Lordick; Ronan J Kelly; Zsolt Szabo; Z Alexander Cao; Stephen Leong; David H Ilson; Wilko Weichert
Journal:  J Cancer Res Clin Oncol       Date:  2022-05-13       Impact factor: 4.322

3.  Identification of immune subtypes of cervical squamous cell carcinoma predicting prognosis and immunotherapy responses.

Authors:  Yimin Li; Shun Lu; Shubin Wang; Xinhao Peng; Jinyi Lang
Journal:  J Transl Med       Date:  2021-05-24       Impact factor: 5.531

4.  Tumor Mutational Burden as a Predictive Biomarker in Solid Tumors.

Authors:  Dan Sha; Zhaohui Jin; Jan Budczies; Klaus Kluck; Albrecht Stenzinger; Frank A Sinicrope
Journal:  Cancer Discov       Date:  2020-11-02       Impact factor: 38.272

Review 5.  Cancer Immunotherapy Update: FDA-Approved Checkpoint Inhibitors and Companion Diagnostics.

Authors:  Julianne D Twomey; Baolin Zhang
Journal:  AAPS J       Date:  2021-03-07       Impact factor: 4.009

6.  Comprehensive analysis of tumor mutation burden and immune microenvironment in gastric cancer.

Authors:  Jie Yu; QianYun Zhang; MengChuan Wang; SiJia Liang; HongYun Huang; Lang Xie; ChunHui Cui; JinLong Yu
Journal:  Biosci Rep       Date:  2021-02-26       Impact factor: 3.840

7.  Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer.

Authors:  Matthew D Galsky; Arjun V Balar; Peter C Black; Matthew T Campbell; Gail S Dykstra; Petros Grivas; Shilpa Gupta; Christoper J Hoimes; Lidia P Lopez; Joshua J Meeks; Elizabeth R Plimack; Jonathan E Rosenberg; Neal Shore; Gary D Steinberg; Ashish M Kamat
Journal:  J Immunother Cancer       Date:  2021-07       Impact factor: 13.751

Review 8.  Perioperative Systemic Treatment for Muscle-Invasive Bladder Cancer: Current Evidence and Future Perspectives.

Authors:  In-Ho Kim; Hyo-Jin Lee
Journal:  Int J Mol Sci       Date:  2021-07-04       Impact factor: 5.923

9.  Patient specific circulating tumor DNA fingerprints to monitor treatment response across multiple tumors.

Authors:  Jiaping Li; Wei Jiang; Jinwang Wei; Jianwei Zhang; Linbo Cai; Minjie Luo; Zhan Wang; Wending Sun; Shengzhou Wang; Chen Wang; Chun Dai; Jun Liu; Guan Wang; Jiping Wang; Qiang Xu; Yanhong Deng
Journal:  J Transl Med       Date:  2020-08-01       Impact factor: 5.531

Review 10.  Targeted Molecular Therapeutics for Bladder Cancer-A New Option beyond the Mixed Fortunes of Immune Checkpoint Inhibitors?

Authors:  Olga Bednova; Jeffrey V Leyton
Journal:  Int J Mol Sci       Date:  2020-10-01       Impact factor: 5.923
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