Literature DB >> 25059519

"Companion diagnostics": has their time come and gone?

Fred R Hirsch1, Paul A Bunn2, Roy S Herbst3.   

Abstract

Rapid development of molecularly targeted drugs requires a "companion diagnostic" that could delay drug development and limit availability of active drugs for relevant patients. Were the negative results from MetMab studies in patients with advanced non-small cell lung cancer due to drug failure or failure of the right companion diagnostic? ©2014 American Association for Cancer Research.

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Year:  2014        PMID： 25059519      PMCID： PMC4155019          DOI： 10.1158/1078-0432.CCR-14-0932

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


  8 in total

1.  Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib±onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit.

Authors:  Hartmut Koeppen; Wei Yu; Jiping Zha; Ajay Pandita; Elicia Penuel; Linda Rangell; Rajiv Raja; Sankar Mohan; Rajesh Patel; Rupal Desai; Ling Fu; An Do; Vaishali Parab; Xiaoling Xia; Tom Januario; Sharianne G Louie; Ellen Filvaroff; David S Shames; Ignacio Wistuba; Marina Lipkind; Jenny Huang; Mirella Lazarov; Vanitha Ramakrishnan; Lukas Amler; See-Chun Phan; Premal Patel; Amy Peterson; Robert L Yauch
Journal:  Clin Cancer Res       Date:  2014-03-31       Impact factor: 12.531

2.  Erlotinib in previously treated non-small-cell lung cancer.

Authors:  Frances A Shepherd; José Rodrigues Pereira; Tudor Ciuleanu; Eng Huat Tan; Vera Hirsh; Sumitra Thongprasert; Daniel Campos; Savitree Maoleekoonpiroj; Michael Smylie; Renato Martins; Maximiliano van Kooten; Mircea Dediu; Brian Findlay; Dongsheng Tu; Dianne Johnston; Andrea Bezjak; Gary Clark; Pedro Santabárbara; Lesley Seymour
Journal:  N Engl J Med       Date:  2005-07-14       Impact factor: 91.245

3.  Next-generation sequencing identifies and immunohistochemistry confirms a novel crizotinib-sensitive ALK rearrangement in a patient with metastatic non-small-cell lung cancer.

Authors:  Nir Peled; Gary Palmer; Fred R Hirsch; Murry W Wynes; Maya Ilouze; Marileila Varella-Garcia; Lior Soussan-Gutman; Geoff A Otto; Philip J Stephens; Jeffrey S Ross; Maureen T Cronin; Doron Lipson; Vincent A Miller
Journal:  J Thorac Oncol       Date:  2012-09       Impact factor: 15.609

Review 4.  Mechanisms of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer.

Authors:  Jeffrey A Engelman; Pasi A Jänne
Journal:  Clin Cancer Res       Date:  2008-05-15       Impact factor: 12.531

5.  Randomized phase II trial of Onartuzumab in combination with erlotinib in patients with advanced non-small-cell lung cancer.

Authors:  David R Spigel; Thomas J Ervin; Rodryg A Ramlau; Davey B Daniel; Jerome H Goldschmidt; George R Blumenschein; Maciej J Krzakowski; Gilles Robinet; Benoit Godbert; Fabrice Barlesi; Ramaswamy Govindan; Taral Patel; Sergey V Orlov; Michael S Wertheim; Wei Yu; Jiping Zha; Robert L Yauch; Premal H Patel; See-Chun Phan; Amy C Peterson
Journal:  J Clin Oncol       Date:  2013-10-07       Impact factor: 44.544

6.  Atypical negative ALK break-apart FISH harboring a crizotinib-responsive ALK rearrangement in non-small-cell lung cancer.

Authors:  Shengxiang Ren; Fred R Hirsch; Marileila Varella-Garcia; Dara L Aisner; Theresa Boyle; Caicun Zhou; D Ross Camidge
Journal:  J Thorac Oncol       Date:  2014-03       Impact factor: 15.609

7.  An international interpretation study using the ALK IHC antibody D5F3 and a sensitive detection kit demonstrates high concordance between ALK IHC and ALK FISH and between evaluators.

Authors:  Murry W Wynes; Lynette M Sholl; Manfred Dietel; Ed Schuuring; Ming S Tsao; Yasushi Yatabe; Raymond R Tubbs; Fred R Hirsch
Journal:  J Thorac Oncol       Date:  2014-05       Impact factor: 15.609

8.  Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.

Authors:  Shakun M Malik; Richard Pazdur; Jeffrey S Abrams; Mark A Socinski; William T Sause; David H Harpole; John J Welch; Edward L Korn; Claudio Dansky Ullmann; Fred R Hirsch
Journal:  J Thorac Oncol       Date:  2014-10       Impact factor: 15.609
  8 in total
  7 in total

Review 1.  A 2015 update on predictive molecular pathology and its role in targeted cancer therapy: a review focussing on clinical relevance.

Authors:  M Dietel; K Jöhrens; M V Laffert; M Hummel; H Bläker; B M Pfitzner; A Lehmann; C Denkert; S Darb-Esfahani; D Lenze; F L Heppner; A Koch; C Sers; F Klauschen; I Anagnostopoulos
Journal:  Cancer Gene Ther       Date:  2015-09-11       Impact factor: 5.987

Review 2.  Next-generation clinical trials: Novel strategies to address the challenge of tumor molecular heterogeneity.

Authors:  Daniel V T Catenacci
Journal:  Mol Oncol       Date:  2014-10-18       Impact factor: 6.603

3.  Identification of a novel MET mutation in high-grade glioma resulting in an auto-active intracellular protein.

Authors:  Anna C Navis; Sanne A M van Lith; Sander M J van Duijnhoven; Maaike de Pooter; Bahar Yetkin-Arik; Pieter Wesseling; Wiljan J A J Hendriks; Hanka Venselaar; Marco Timmer; Patricia van Cleef; Paul van Bergen En Henegouwen; Myron G Best; Thomas D Wurdinger; Bastiaan B J Tops; William P J Leenders
Journal:  Acta Neuropathol       Date:  2015-04-11       Impact factor: 17.088

Review 4.  PD-L1 testing, fit for routine evaluation? From a pathologist's point of view.

Authors:  Georg Hutarew
Journal:  Memo       Date:  2016-10-28

5.  An appraisal of drug development timelines in the Era of precision oncology.

Authors:  Denis Leonardo Jardim; Maria Schwaederle; David S Hong; Razelle Kurzrock
Journal:  Oncotarget       Date:  2016-08-16

Review 6.  Changes in Companion Diagnostic Labelling: Implementation of FDA's April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups.

Authors:  Lisa Cooper; Joyce Chen
Journal:  Ther Innov Regul Sci       Date:  2022-06-10       Impact factor: 1.337

7.  A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753).

Authors:  Saiama N Waqar; Mary W Redman; Susanne M Arnold; Fred R Hirsch; Philip C Mack; Lawrence H Schwartz; David R Gandara; Thomas E Stinchcombe; Natasha B Leighl; Suresh S Ramalingam; Saloni H Tanna; Ryan S Raddin; Katherine Minichiello; Jeffrey D Bradley; Karen Kelly; Roy S Herbst; Vassiliki A Papadimitrakopoulou
Journal:  Clin Lung Cancer       Date:  2020-10-14       Impact factor: 4.785
  7 in total

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