DK3152577T3 - Signifikans af intratumoral her2-heterogenitet i brystkræft og anvendelser hefar - Google Patents
Signifikans af intratumoral her2-heterogenitet i brystkræft og anvendelser hefar Download PDFInfo
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- DK3152577T3 DK3152577T3 DK15726957.2T DK15726957T DK3152577T3 DK 3152577 T3 DK3152577 T3 DK 3152577T3 DK 15726957 T DK15726957 T DK 15726957T DK 3152577 T3 DK3152577 T3 DK 3152577T3
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57407—Specifically defined cancers
- G01N33/57415—Specifically defined cancers of breast
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- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
- C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
- C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
- G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
- G01N33/57492—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds localized on the membrane of tumor or cancer cells
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q2600/00—Oligonucleotides characterized by their use
- C12Q2600/158—Expression markers
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
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- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
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- Molecular Biology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
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- Urology & Nephrology (AREA)
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- General Physics & Mathematics (AREA)
- Food Science & Technology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
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- Biophysics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Claims (9)
1. In vitro-fremgangsmåde til forudsigelse af modtagelighed for en HER2-rettet behandling via vurdering af HER2-heterogenitet i en tumor, hvilken fremgangsmåde omfatter: • at bringe en prøve af tumoren i kontakt med et antistof, der specifikt binder sig til HER2-protein, og påvisning af HER2-protein i prøven, • at bringe prøven af tumoren i kontakt med en nukleinsyreprobe, der specifikt binder til HER2-genomisk DNA, og påvisning af HER2-genamplifikationsstatus i prøven, • at score HER2-proteinet (IHC) og HER2-genet (DISH), hvor scoringen er kategoriseret som: o gruppe A for prøver, der udviser IHC 3+ og DISH+, o gruppe B for prøver, der udviser IHC 3+ og DISH-, o gruppe C for prøver, der udviser IHC 2+ og DISH+, o gruppe D for prøver, der udviser IHC 2+ og DISH-, o gruppe E for prøver, der udviser IHC 0, 1+ og DISH+, og o gruppe F for prøver, der udviser IHC 0, 1+ og DISH-, • at forudsige, at tumoren er modtagelig for den HER2-rettede behandling, hvis tumoren afslører et første foci, der har en første score, som er gruppe F, og et andet foci, der har en anden score, som er valgt fra gruppe A til gruppe E.
2. Fremgangsmåde ifølge krav 1, hvor fremgangsmåden endvidere omfatter analyse af en anden prøve af tumoren for østrogenreceptor (ER) og progesteronreceptor (PR), hvor tumoren forudsiges at være modtagelig for den HER2-rettede behandling, hvis ER og PR er negative, således at tumoren forstås som triple-negativ brystkræft (TNBC).
3. Fremgangsmåde ifølge krav 1, hvor fremgangsmåden endvidere omfatter: • at bringe en prøve af tumoren i kontakt med et antistof, der specifikt binder til østrogenreceptor (ER)-protein, og påvisning af ER-protein i prøven, • at bringe en prøve af tumoren i kontakt med et antistof, der specifikt binder til progesteronreceptor (PR)-protein, og påvisning af PR-protein i prøven, hvor tumoren forudsiges at være modtagelig for den HER2-rettede behandling, hvis ER og PR er negative, således at tumoren forstås som triple-negativ brystcancer (TNBC).
4. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3, hvor den HER-2- rettede behandling er valgt fra gruppen bestående af trastuzumab, trastuzumab emtansin, pertuzumab, neratinib og lapatinib.
5. In vitro-fremgangsmåde til scoring en tumorprøve, hvilken fremgangsmåde omfatter: • at bringe tumorprøven i kontakt med et antistof, der specifikt binder til HER2-protein, og påvisning af HER2-protein i prøven, • at bringe tumorprøven i kontakt med en nukleinsyreprobe, der specifikt binder til HER2-genomisk DNA, og påvisning af HER2-genamplifikationsstatus i prøven, • at score HER2-proteinet (IHC) og HER2-genet (DISH), hvor scoringen er kategoriseret som: o gruppe A for prøver, der udviser IHC 3+ og DISH+, o gruppe B for prøver, der udviser IHC 3+ og DISH-, o gruppe C for prøver, der udviser IHC 2+ og DISH+, o gruppe D for prøver, der udviser IHC 2+ og DISH-, o gruppe E for prøver, der udviser IHC 0, 1+ og DISH+, og o gruppe F for prøver, der udviser IHC 0, 1+ og DISH-, • at score tumorprøven som heterogen, hvis tumoren afslører et første foci, der har en første score, som er gruppe F, og et andet foci, der har en anden score, som er valgt fra gruppe A til gruppe E.
6. Fremgangsmåde ifølge krav 5, hvor fremgangsmåden endvidere omfatter prognosticering af et fare forhold på mere end 5, hvis tumorprøven er scoret som heterogen.
7. Fremgangsmåde ifølge krav 5, hvor fremgangsmåden endvidere omfatter analyse af en anden prøve af tumoren for østrogenreceptor (ER) og progesteronreceptor (PR), hvor tumoren forudsiges at være modtagelig for en HER2-rettet behandling, hvis ER og PR er negative, således at tumoren forstås som triple-negativ brystkræft (TNBC).
8. Fremgangsmåde ifølge krav 5, hvor fremgangsmåden endvidere omfatter: • at bringe en prøve af tumoren i kontakt med et antistof, der specifikt binder til østrogenreceptor (ER)-protein, og påvisning af ER-protein i prøven, • at bringe en prøve af tumoren i kontakt med et antistof, der specifikt binder til progesteronreceptor (PR)-protein, og påvisning af PR-protein i prøven, hvor tumoren forudsiges at være modtagelig for den HER2-rettede behandling, hvis ER og PR er negative, således at tumoren forstås som værende triple-negativ brystcancer (TNBC).
9. Fremgangsmåde ifølge krav 7 eller 8, hvor fremgangsmåden endvidere omfatter prognosticering af en signifikant dårligere overlevelsesscore sammenlignet med en ikke-hetero gen score (RFS: P=0.0176; CSS: P=0.0199), hvis prøven scores som heterogen.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462009057P | 2014-06-06 | 2014-06-06 | |
| PCT/EP2015/062331 WO2015185595A1 (en) | 2014-06-06 | 2015-06-03 | Significance of intratumoral her2 heterogeneity in breast cancer and uses therefore |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3152577T3 true DK3152577T3 (da) | 2018-10-01 |
Family
ID=53284260
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15726957.2T DK3152577T3 (da) | 2014-06-06 | 2015-06-03 | Signifikans af intratumoral her2-heterogenitet i brystkræft og anvendelser hefar |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20170082627A1 (da) |
| EP (1) | EP3152577B1 (da) |
| JP (1) | JP6626097B2 (da) |
| AU (1) | AU2015270575B2 (da) |
| CA (1) | CA2948420A1 (da) |
| DK (1) | DK3152577T3 (da) |
| ES (1) | ES2688079T3 (da) |
| WO (1) | WO2015185595A1 (da) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG11201700207WA (en) | 2014-07-11 | 2017-02-27 | Genentech Inc | Anti-pd-l1 antibodies and diagnostic uses thereof |
| WO2019224153A1 (en) | 2018-05-21 | 2019-11-28 | Genentech, Inc. | Her2 heterogeneity as a biomarker in cancer |
| JP2021531790A (ja) | 2018-07-27 | 2021-11-25 | ベンタナ メディカル システムズ， インコーポレイテッド | 自動化された原位置ハイブリッド形成分析のためのシステム |
| EP3844771A1 (en) | 2018-08-31 | 2021-07-07 | Ventana Medical Systems, Inc. | Contextually adaptive digital pathology interface |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5595707A (en) | 1990-03-02 | 1997-01-21 | Ventana Medical Systems, Inc. | Automated biological reaction apparatus |
| US6582962B1 (en) | 1998-02-27 | 2003-06-24 | Ventana Medical Systems, Inc. | Automated molecular pathology apparatus having independent slide heaters |
| US6296809B1 (en) | 1998-02-27 | 2001-10-02 | Ventana Medical Systems, Inc. | Automated molecular pathology apparatus having independent slide heaters |
| US6649138B2 (en) | 2000-10-13 | 2003-11-18 | Quantum Dot Corporation | Surface-modified semiconductive and metallic nanoparticles having enhanced dispersibility in aqueous media |
| US20020083888A1 (en) | 2000-12-28 | 2002-07-04 | Zehnder Donald A. | Flow synthesis of quantum dot nanocrystals |
| US6670113B2 (en) | 2001-03-30 | 2003-12-30 | Nanoprobes | Enzymatic deposition and alteration of metals |
| EP1409240B1 (en) | 2001-07-20 | 2012-05-09 | Life Technologies Corporation | Luminescent nanoparticles and methods for their preparation |
| US7642064B2 (en) | 2003-06-24 | 2010-01-05 | Ventana Medical Systems, Inc. | Enzyme-catalyzed metal deposition for the enhanced detection of analytes of interest |
| EP1636586B1 (en) | 2003-06-24 | 2009-07-22 | Ventana Medical Systems, Inc. | Enzyme-catalyzed metal deposition for the enhanced in situ detection of immunohistochemical epitopes and nucleic acid sequences |
| WO2008043104A2 (en) * | 2006-10-06 | 2008-04-10 | Applied Genomics Inc. | Reagents and methods for use in cancer diagnosis, classification and therapy |
| ES2465465T3 (es) | 2006-11-01 | 2014-06-05 | Ventana Medical Systems, Inc. | Haptenos, conjugados de haptenos, composiciones de los mismos y método para su preparación y uso |
| WO2010136569A1 (en) * | 2009-05-29 | 2010-12-02 | F. Hoffmann-La Roche Ag | Modulators for her2 signaling in her2 expressing patients with gastric cancer |
| WO2012024185A1 (en) | 2010-08-16 | 2012-02-23 | Ventana Medical Systems, Inc. | Substrates for chromogenic detection and methods of use in detection assays and kits |
| US20120052508A1 (en) * | 2010-08-27 | 2012-03-01 | Rutgers, The State University Of New Jersey | Genetic markers and diagnostic methods for resistance of breast cancer to hormonal therapies |
| US10041950B2 (en) | 2012-03-27 | 2018-08-07 | Ventana Medical Systems, Inc. | Signaling conjugates and methods of use |
-
2015
- 2015-06-03 CA CA2948420A patent/CA2948420A1/en not_active Abandoned
- 2015-06-03 ES ES15726957.2T patent/ES2688079T3/es active Active
- 2015-06-03 WO PCT/EP2015/062331 patent/WO2015185595A1/en active Application Filing
- 2015-06-03 EP EP15726957.2A patent/EP3152577B1/en active Active
- 2015-06-03 JP JP2017516192A patent/JP6626097B2/ja active Active
- 2015-06-03 AU AU2015270575A patent/AU2015270575B2/en active Active
- 2015-06-03 DK DK15726957.2T patent/DK3152577T3/da active
-
2016
- 2016-12-06 US US15/371,165 patent/US20170082627A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| ES2688079T3 (es) | 2018-10-30 |
| WO2015185595A1 (en) | 2015-12-10 |
| EP3152577A1 (en) | 2017-04-12 |
| EP3152577B1 (en) | 2018-07-18 |
| AU2015270575A1 (en) | 2016-10-27 |
| US20170082627A1 (en) | 2017-03-23 |
| CA2948420A1 (en) | 2015-12-10 |
| JP6626097B2 (ja) | 2019-12-25 |
| AU2015270575B2 (en) | 2019-07-25 |
| JP2017520001A (ja) | 2017-07-20 |
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