Co-development of a companion diagnostic for targeted cancer therapy

New Biotechnology - Tập 29 - Trang 682-688 - 2012
Suzanne Cheng1, Walter H. Koch1, Lin Wu1
1Roche Molecular Systems, Inc, 4300 Hacienda Dr, Pleasanton, CA, 94588, USA

Tài liệu tham khảo

Kola, 2008, The state of innovation in drug development, Clin. Pharmacol. Ther., 83, 227, 10.1038/sj.clpt.6100479 Hait, 2010, Anticancer drug development: the grand challenges, Nat. Rev. Drug Discov., 9, 253, 10.1038/nrd3144 Westhouse, 2010, Safety assessment considerations and strategies for targeted small molecule cancer therapeutics in drug discovery, Toxicol. Pathol., 38, 165, 10.1177/0192623309354341 McDermott, 2009, Personalized cancer therapy with selective kinase inhibitors: an emerging paradigm in medical oncology, J. Clin. Oncol., 27, 5650, 10.1200/JCO.2009.22.9054 Bozic, 2010, Accumulation of driver and passenger mutations during tumor progression, Proc. Natl. Acad. Sci. U. S. A., 107, 18545, 10.1073/pnas.1010978107 Haber, 2007, Cancer: drivers and passengers, Nature, 446, 145, 10.1038/446145a Stratton, 2009, The cancer genome, Nature, 458, 719, 10.1038/nature07943 Vandin, 2011, De novo discovery of mutated driver pathways in cancer, Genome Res., 22, 375, 10.1101/gr.120477.111 Weinstein, 2002, Addiction to oncogenes – the Achilles heal of cancer, Science, 297, 63, 10.1126/science.1073096 Zhang, 2009, Targeting cancer with small molecule kinase inhibitors, Nat. Rev. Cancer, 9, 28, 10.1038/nrc2559 Jordan, 2006, Tamoxifen (ICI46,474) as a targeted therapy to treat and prevent breast cancer, Br. J. Pharmacol., 147, S269, 10.1038/sj.bjp.0706399 Slamon, 1989, Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer, Science, 244, 707, 10.1126/science.2470152 Baselga, 2001, Mechanism of action of trastuzumab and scientific update, Semin. Oncol., 28, 4, 10.1016/S0093-7754(01)90276-3 Yamauchi, 2001, When is a tumor marker ready for prime time? A case study of c-erbB-2 as a predictive factor in breast cancer, J. Clin. Oncol., 19, 2334, 10.1200/JCO.2001.19.8.2334 Deininger, 1997, The tyrosine kinase inhibitor CGP57148B selectively inhibits the growth of BCR-ABL-positive cells, Blood, 90, 3691, 10.1182/blood.V90.9.3691 Druker, 1996, Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells, Nat. Med., 2, 561, 10.1038/nm0596-561 Gambacorti-Passerini, 1997, Inhibition of the ABL kinase activity blocks the proliferation of BCR/ABL+ leukemic cells and induces apoptosis, Blood Cells Mol. Dis., 23, 380, 10.1006/bcmd.1997.0155 Papadopoulos, 2006, The role of companion diagnostics in the development and use of mutation-targeted cancer therapies, Nat. Biotechnol., 24, 985, 10.1038/nbt1234 Riely, 2006, Update on epidermal growth factor receptor mutations in non-small cell lung cancer, Clin. Cancer Res., 12, 7232, 10.1158/1078-0432.CCR-06-0658 Amado, 2008, Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer, J. Clin. Oncol., 26, 1626, 10.1200/JCO.2007.14.7116 Lièvre, 2006, KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer, Cancer Res., 66, 3992, 10.1158/0008-5472.CAN-06-0191 Geller, 2011, Reducing mortality in individuals at high risk for advanced melanoma through education and screening, J. Am. Acad. Dermatol., 65, S87, 10.1016/j.jaad.2011.05.045 Balch, 2009, Final version of 2009 AJCC melanoma staging and classification, J. Clin. Oncol., 27, 6199, 10.1200/JCO.2009.23.4799 Chapman, 2011, Improved survival with vemurafenib in melanoma with BRAF V600E mutation, N. Engl. J. Med., 364, 2507, 10.1056/NEJMoa1103782 Atkins, 1999, High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993, J. Clin. Oncol., 17, 2105, 10.1200/JCO.1999.17.7.2105 Robert, 2011, Ipilimumab plus dacarbazine for previously untreated metastatic melanoma, N. Engl. J. Med., 364, 2517, 10.1056/NEJMoa1104621 Wolchok, 2010, Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study, Lancet Oncol., 11, 155, 10.1016/S1470-2045(09)70334-1 Davies, 2002, Mutations of the BRAF gene in human cancer, Nature, 417, 949, 10.1038/nature00766 Pollock, 2003, High frequency of BRAF mutations in nevi, Nat. Genet., 33, 19, 10.1038/ng1054 Curtin, 2005, Distinct sets of genetic alterations in melanoma, N. Engl. J. Med., 353, 2135, 10.1056/NEJMoa050092 Wellcome Trust Sanger Institute. Catalogue of Somatic Mutations in Cancer Database. http://www.sanger.ac.uk/genetics/CGP/cosmic [accessed July 2011] Long, 2011, Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma, J. Clin. Oncol., 29, 1239, 10.1200/JCO.2010.32.4327 Wan, 2004, Mechanism of activation of the RAF-ERK signaling pathway by oncogenic mutations of B-RAF, Cell, 116, 855, 10.1016/S0092-8674(04)00215-6 Bollag, 2010, Clinical efficacy of a RAF inhibitor needs broad target blockade in BRAF-mutant melanoma, Nature, 467, 596, 10.1038/nature09454 Søndergaard, 2010, Differential sensitivity of melanoma cell lines with BRAFV600E mutation to the specific Raf inhibitor PLX4032, J. Transl. Med., 8, 39, 10.1186/1479-5876-8-39 Yang, 2010, RG7204 (PLX4032), a selective BRAFV600E inhibitor, displays potent antitumor activity in preclinical melanoma models, Cancer Res., 70, 5518, 10.1158/0008-5472.CAN-10-0646 Halait, 2012, The analytic performance of a real-time PCR-based assay for V600 mutations in the BRAF gene, used as the companion diagnostic test for the novel BRAF inhibitor vemurafenib in metastatic melanoma, Diagn. Mol. Pathol., 21, 1, 10.1097/PDM.0b013e31823b216f Klopfleisch, 2011, Excavation of a buried treasure – DNA, mRNA, miRNA and protein analysis in formalin fixed, paraffin embedded tissues, Histol. Histopathol., 26, 797 Ogino, 2005, Sensitive sequencing method for KRAS mutation detection by pyrosequencing, J. Mol. Diagn., 7, 413, 10.1016/S1525-1578(10)60571-5 Pichler, 2009, Evaluation of high-resolution melting analysis as a diagnostic tool to detect the BRAF V600E mutation in colorectal tumors, J. Mol. Diagn., 11, 140, 10.2353/jmoldx.2009.080100 Tan, 2008, Detection of BRAF V600E mutation by pyrosequencing, Pathology, 40, 295, 10.1080/00313020801911512 Tsiatis, 2010, Comparison of Sanger sequencing, pyrosequencing, and melting curve analysis for the detection of KRAS mutations: diagnostic and clinical implications, J. Mol. Diagn., 12, 425, 10.2353/jmoldx.2010.090188 Anderson, S. et al. (2012) Multisite analytic performance studies of a real-time polymerase chain reaction assay for the detection of BRAF V600E mutations in formalin-fixed paraffin-embedded tissue specimens of malignant melanoma. Arch. Pathol. Lab. Med. epub 14Feb12 [http://dx.doi.org/10.5858/arpa.2011-0505-OA]. Thomas, 2006, Sensitive mutation detection in heterogeneous cancer specimens by massively parallel picoliter reactor sequencing, Nat. Med., 12, 852, 10.1038/nm1437 Flaherty, 2010, Inhibition of mutated, activated BRAF in metastatic melanoma, N. Engl. J. Med., 363, 809, 10.1056/NEJMoa1002011 Sosman, 2012, Survival in BRAF V600–mutant advanced melanoma treated with vemurafenib, New Engl. J. Med., 366, 707, 10.1056/NEJMoa1112302 US Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff. In Vitro Companion Diagnostic Devices. Document 1737, issued July 14, 2011. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm [accessed August 2011] Hoffmann-La Roche Ltd. Zelboraf™ (vemurafenib) Prescribing Information. 2011. Basel, Switzerland Roche Molecular Systems Inc. cobas® 4800 BRAF V600 Mutation Test Package Insert. 2011. Hoffmann-La Roche Ltd. Zelboraf™ (vemurafenib) EU Summary of Product Characteristics. 2012. Basel, Switzerland. Garrett, 2011, Resistance to HER2-directed antibodies and tyrosine kinase inhibitors, Cancer Biol. Ther., 11, 793, 10.4161/cbt.11.9.15045 Stegmeier, 2010, Targeted cancer therapies in the twenty-first century: lessons from imatinib, Clin. Pharmacol. Ther., 87, 543, 10.1038/clpt.2009.297 Wagle, 2011, Dissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profiling, J. Clin. Oncol., 29, 3085, 10.1200/JCO.2010.33.2312