EP2176429A1 - Vorhersagemarker für egfr-inhibitor-behandlung - Google Patents

Vorhersagemarker für egfr-inhibitor-behandlung

Info

Publication number
EP2176429A1
EP2176429A1 EP08785424A EP08785424A EP2176429A1 EP 2176429 A1 EP2176429 A1 EP 2176429A1 EP 08785424 A EP08785424 A EP 08785424A EP 08785424 A EP08785424 A EP 08785424A EP 2176429 A1 EP2176429 A1 EP 2176429A1
Authority
EP
European Patent Office
Prior art keywords
patients
cancer
treatment
gene
egfr inhibitor
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP08785424A
Other languages
English (en)
French (fr)
Inventor
Paul Delmar
Barbara Klughammer
Verena Lutz
Patricia Mcloughlin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Priority to EP08785424A priority Critical patent/EP2176429A1/de
Publication of EP2176429A1 publication Critical patent/EP2176429A1/de
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • 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
    • 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
    • C12Q2600/118—Prognosis of disease development
    • 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

Definitions

  • TarcevaTM was given orally once per day at a dose of 150 mg until disease progression, intolerable toxicities or death.
  • the selection of this dose was based on pharmacokinetic parameters, as well as the safety and tolerability profile of this dose observed in Phase I, II and III trials in heavily pre-treated patients with advanced cancer.
  • Drug levels seen in the plasma of patients with cancer receiving the 150 mg/day dose were consistently above the average plasma concentration of 500 ng / ml targeted for clinical efficacy.
  • BR.21 showed a survival benefit with this dose.
  • Affymetrix HG-U 133 A microarrays contain over 22,000 probe sets targeting approximately 18,400 transcripts and variants which represent about 14,500 well- characterized genes.
  • Step 5 was a robustness analysis. The goal was to generate a qualified list of candidate markers that do not heavily depend on the pre-processing methods and statistical assumptions. It consisted in reiterating the analysis with different methodological approaches and intersecting the list of candidates.
  • Descriptive exploratory analysis was performed to identify potential bias and major sources of variability.
  • a set of covariates with a potential impact on gene expression profiles was screened. It comprised both technical and clinical variables.
  • Technical covariates included: date of RNA processing (later referred to as batch), RIN (as a measure of RNA quality/integrity), Operator and Center of sample collection.
  • Clinical covariates included: Histology type, smoking status, tumour grade, performance score (Oken, M.M., et al., Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol, 1982. 5(6): p. 649-55), demographic data, responder status and clinical benefit status.
  • the analysis tools included univariate ANOVA and principal component analysis. For each of these covariates, univariate ANOVA was applied independently to each probe-set.
EP08785424A 2007-08-14 2008-08-07 Vorhersagemarker für egfr-inhibitor-behandlung Ceased EP2176429A1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08785424A EP2176429A1 (de) 2007-08-14 2008-08-07 Vorhersagemarker für egfr-inhibitor-behandlung

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07114305 2007-08-14
EP08785424A EP2176429A1 (de) 2007-08-14 2008-08-07 Vorhersagemarker für egfr-inhibitor-behandlung
PCT/EP2008/006518 WO2009021679A1 (en) 2007-08-14 2008-08-07 Predictive marker for egfr inhibitor treamtent

Publications (1)

Publication Number Publication Date
EP2176429A1 true EP2176429A1 (de) 2010-04-21

Family

ID=39789783

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08785424A Ceased EP2176429A1 (de) 2007-08-14 2008-08-07 Vorhersagemarker für egfr-inhibitor-behandlung

Country Status (9)

Country Link
EP (1) EP2176429A1 (de)
JP (1) JP2010535520A (de)
KR (1) KR20100037633A (de)
CN (1) CN101802221A (de)
AU (1) AU2008286412A1 (de)
BR (1) BRPI0815372A2 (de)
CA (1) CA2695318A1 (de)
MX (1) MX2010001572A (de)
WO (1) WO2009021679A1 (de)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5646249A (en) * 1994-02-28 1997-07-08 The United States Of America As Represented By The Department Of Health And Human Services Isolation and characterization of a novel chaperone protein
WO2004111273A2 (en) * 2003-05-30 2004-12-23 Genomic Health, Inc. Gene expression markers for response to egfr inhibitor drugs
NZ543234A (en) * 2003-05-30 2009-04-30 Astrazeneca Uk Ltd Marker genes and uses thereof to identify cancer patients that will respond to erbb tyrosine kinase inhibitors

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2009021679A1 *

Also Published As

Publication number Publication date
KR20100037633A (ko) 2010-04-09
JP2010535520A (ja) 2010-11-25
CA2695318A1 (en) 2009-02-19
MX2010001572A (es) 2010-03-15
CN101802221A (zh) 2010-08-11
WO2009021679A1 (en) 2009-02-19
BRPI0815372A2 (pt) 2019-09-24
AU2008286412A1 (en) 2009-02-19

Similar Documents

Publication Publication Date Title
EP2188391A1 (de) Prognosemarker zur behandlung mit egfr-hemmern
US20110218212A1 (en) Predictive markers for egfr inhibitors treatment
EP2179057B1 (de) Prognosemarker zur behandlung mit egfr-hemmern
EP2179058A2 (de) Prognosemarker zur behandlung mit egfr-hemmern
US20110195982A1 (en) Predictive marker for egfr inhibitor treatment
US9121067B2 (en) Predictive marker for EGFR inhibitor treatment
US20110312981A1 (en) Predictive marker for egfr inhibitor treatment
WO2009021679A1 (en) Predictive marker for egfr inhibitor treamtent
EP2188393A1 (de) Prognosemarker zur behandlung mit egfr-hemmern
US20110184004A1 (en) Predictive marker for egfr inhibitor treatment
EP2179055A1 (de) Vorhersagemarker für die egfr-inhibitor-behandlung

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20100315

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR

AX Request for extension of the european patent

Extension state: AL BA MK RS

17Q First examination report despatched

Effective date: 20100610

DAX Request for extension of the european patent (deleted)
REG Reference to a national code

Ref country code: DE

Ref legal event code: R003

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN REFUSED

18R Application refused

Effective date: 20110711