Co-development of a companion diagnostic for targeted cancer therapy

New Biotechnology

Volumn 29, Issue 6, 2012, Pages 682-688

  Cheng, Suzanne ^a   Koch, Walter H ^a   Wu, Lin ^a  

^a ROCHE MOLECULAR SYSTEMS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CO-DEVELOPMENT; DEVELOPMENT PROCESS; DEVELOPMENT TEAMS; DEVELOPMENT TIME; DIAGNOSTIC TESTS; DRUG DEVELOPMENT; INTEGRATED PROCESS; INVESTIGATIONAL NEW DRUGS; KEY SUCCESS FACTORS; METASTATIC MELANOMA; PARALLEL DEVELOPMENT; PERSONALIZED MEDICINES; SELECTIVE INHIBITORS; TARGETED CANCER THERAPY; THERAPEUTIC TARGETS;

DERMATOLOGY; DIAGNOSIS; ENZYMES; GENE THERAPY;

ONCOLOGY;

B RAF KINASE; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR 2; IMATINIB; IPILIMUMAB; PANITUMUMAB; TAMOXIFEN; VEMURAFENIB;

ALLELE; ANTIBODY DEPENDENT CELLULAR CYTOTOXICITY; ARTICLE; CANCER DIAGNOSIS; CANCER GROWTH; CANCER INHIBITION; CANCER SURVIVAL; CLINICAL TRIAL (TOPIC); CODON; COLORECTAL CANCER; DIAGNOSTIC TEST; DRUG EFFICACY; DRUG RECEPTOR BINDING; DRUG SELECTIVITY; GENE MUTATION; GENOMIC INSTABILITY; LIMIT OF DETECTION; METASTATIC MELANOMA; MOLECULARLY TARGETED THERAPY; OVERALL SURVIVAL; PERSONALIZED MEDICINE; PHASE 3 CLINICAL TRIAL (TOPIC); PHILADELPHIA 1 CHROMOSOME; PRIORITY JOURNAL;

HUMANS; INDOLES; MOLECULAR DIAGNOSTIC TECHNIQUES; MOLECULAR TARGETED THERAPY; MUTANT PROTEINS; NEOPLASMS; PROTO-ONCOGENE PROTEINS B-RAF; SULFONAMIDES;

EID: 84863590891     PISSN: 18716784     EISSN: 18764347     Source Type: Journal    
DOI: 10.1016/j.nbt.2012.02.002     Document Type: Article

References (53)

1. Kola I. The state of innovation in drug development. Clin. Pharmacol. Ther. 2008, 83:227-230.
2. Hait W.N. Anticancer drug development: the grand challenges. Nat. Rev. Drug Discov. 2010, 9:253-254.
3. Westhouse R.A. Safety assessment considerations and strategies for targeted small molecule cancer therapeutics in drug discovery. Toxicol. Pathol. 2010, 38:165-168.
4. McDermott U., Settleman J. Personalized cancer therapy with selective kinase inhibitors: an emerging paradigm in medical oncology. J. Clin. Oncol. 2009, 27:5650-5659.
5. Bozic I., et al. Accumulation of driver and passenger mutations during tumor progression. Proc. Natl. Acad. Sci. U. S. A. 2010, 107:18545-18550.
6. Haber D.A., Settleman J. Cancer: drivers and passengers. Nature 2007, 446:145-146.
7. Stratton M.R., et al. The cancer genome. Nature 2009, 458:719-724.
8. Vandin F., et al. De novo discovery of mutated driver pathways in cancer. Genome Res. 2011, 22:375-385.
9. Weinstein I.B. Addiction to oncogenes - the Achilles heal of cancer. Science 2002, 297:63-64.
10. Zhang J., et al. Targeting cancer with small molecule kinase inhibitors. Nat. Rev. Cancer 2009, 9:28-39.
11. Jordan V.C. Tamoxifen (ICI46,474) as a targeted therapy to treat and prevent breast cancer. Br. J. Pharmacol. 2006, 147(Suppl. 1):S269-S276.
12. Slamon D.J., et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989, 244:707-712.
13. Baselga J., et al. Mechanism of action of trastuzumab and scientific update. Semin. Oncol. 2001, 28(Suppl. 16):4-11.
14. Yamauchi H., et al. 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. 2001, 19:2334-2356.
15. Deininger M.W.N., et al. The tyrosine kinase inhibitor CGP57148B selectively inhibits the growth of BCR-ABL-positive cells. Blood 1997, 90:3691-3698.
16. Druker B.J., et al. Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat. Med. 1996, 2:561-566.
17. Gambacorti-Passerini C., et al. Inhibition of the ABL kinase activity blocks the proliferation of BCR/ABL+ leukemic cells and induces apoptosis. Blood Cells Mol. Dis. 1997, 23:380-394.
18. Papadopoulos N., et al. The role of companion diagnostics in the development and use of mutation-targeted cancer therapies. Nat. Biotechnol. 2006, 24:985-995.
19. Riely G.J., et al. Update on epidermal growth factor receptor mutations in non-small cell lung cancer. Clin. Cancer Res. 2006, 12:7232-7241.
20. Amado R.G., et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J. Clin. Oncol. 2008, 26:1626-1634.
21. Lièvre A., et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 2006, 66:3992-3995.
22. Geller A.C., et al. Reducing mortality in individuals at high risk for advanced melanoma through education and screening. J. Am. Acad. Dermatol. 2011, 65:S87-S94.
23. Balch C.M., et al. Final version of 2009 AJCC melanoma staging and classification. J. Clin. Oncol. 2009, 27:6199-6206.
24. Chapman P.B., et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 2011, 364:2507-2516.
25. Atkins M.B., et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J. Clin. Oncol. 1999, 17:2105-2116.
26. Robert C., et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N. Engl. J. Med. 2011, 364:2517-2526.
27. Wolchok J.D., et al. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010, 11:155-164.
28. Davies H., et al. Mutations of the BRAF gene in human cancer. Nature 2002, 417:949-954.
29. Pollock P.M., et al. High frequency of BRAF mutations in nevi. Nat. Genet. 2003, 33:19-20.
30. Curtin J.A., et al. Distinct sets of genetic alterations in melanoma. N. Engl. J. Med. 2005, 353:2135-2147.
31. Wellcome Trust Sanger Institute. Catalogue of Somatic Mutations in Cancer Database. [accessed July 2011]. http://www.sanger.ac.uk/genetics/CGP/cosmic.
32. Long G.V., et al. Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J. Clin. Oncol. 2011, 29:1239-1246.
33. Wan P.T., et al. Mechanism of activation of the RAF-ERK signaling pathway by oncogenic mutations of B-RAF. Cell 2004, 116:855-867.
34. Bollag G., et al. Clinical efficacy of a RAF inhibitor needs broad target blockade in BRAF-mutant melanoma. Nature 2010, 467:596-599.
35. Søndergaard J.N., et al. Differential sensitivity of melanoma cell lines with BRAFV600E mutation to the specific Raf inhibitor PLX4032. J. Transl. Med. 2010, 8:39.
36. Yang H., et al. RG7204 (PLX4032), a selective BRAFV600E inhibitor, displays potent antitumor activity in preclinical melanoma models. Cancer Res. 2010, 70:5518-5527.
37. Halait H., et al. 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. 2012, 21:1-8.
38. Klopfleisch R., et al. Excavation of a buried treasure - DNA, mRNA, miRNA and protein analysis in formalin fixed, paraffin embedded tissues. Histol. Histopathol. 2011, 26:797-810.
39. Ogino S., et al. Sensitive sequencing method for KRAS mutation detection by pyrosequencing. J. Mol. Diagn. 2005, 7:413-421.
40. Pichler M., et al. Evaluation of high-resolution melting analysis as a diagnostic tool to detect the BRAF V600E mutation in colorectal tumors. J. Mol. Diagn. 2009, 11:140-147.
41. Tan Y.H., et al. Detection of BRAF V600E mutation by pyrosequencing. Pathology 2008, 40:295-298.
42. Tsiatis A.C., et al. Comparison of Sanger sequencing, pyrosequencing, and melting curve analysis for the detection of KRAS mutations: diagnostic and clinical implications. J. Mol. Diagn. 2010, 12:425-432.
43. 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].
44. Thomas R.K., et al. Sensitive mutation detection in heterogeneous cancer specimens by massively parallel picoliter reactor sequencing. Nat. Med. 2006, 12:852-855.
45. Flaherty K.T., et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N. Engl. J. Med. 2010, 363:809-819.
46. Sosman J.A., et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. New Engl. J. Med. 2012, 366:707-714.
47. 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. [accessed August 2011]. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
48. Hoffmann-La Roche Ltd. Zelboraf™ (vemurafenib) Prescribing Information. 2011. Basel, Switzerland.
49. Roche Molecular Systems Inc. cobas® 4800 BRAF V600 Mutation Test Package Insert. 2011.
50. Hoffmann-La Roche Ltd. Zelboraf™ (vemurafenib) EU Summary of Product Characteristics. 2012. Basel, Switzerland.
51. Garrett J.T., Arteaga C.L. Resistance to HER2-directed antibodies and tyrosine kinase inhibitors. Cancer Biol. Ther. 2011, 11:793-800.
52. Stegmeier F., et al. Targeted cancer therapies in the twenty-first century: lessons from imatinib. Clin. Pharmacol. Ther. 2010, 87:543-552.
53. Wagle N., et al. Dissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profiling. J. Clin. Oncol. 2011, 29:3085-3096.