EGFR blood monitoring

{
  "publication_number": "US9914975B2",
  "country": "US",
  "kind": "B2",
  "title": "EGFR blood monitoring",
  "abstract": "Improved methods of assessing status of a solid-tumor cancer in a subject involving detection of tumor-associated mutations in the subject's blood.",
  "claims": [
    "1. A method of treating a non-small cancer cell lung cancer (NSCLC) patient with a targeted drug therapy, comprising: (a) carrying out a PET scan on the NSCLC patient and assessing metastatic status of the NSCLC patient as M1a or M1b; (b) based on the assessment in step (a), sorting the NSCLC patient as having metastatic status M1a or M1b; (c)(i) obtaining a tumor tissue sample from the NSCLC patient having metastatic status M1a and detecting presence or absence of one or more mutated Epidermal Growth Factor Receptor (EGFR) sequence in the tumor tissue sample from the NSCLC patient by allele-specific PCR; (c)(ii) obtaining a blood sample, and not a tumor tissue sample, from the NSCLC patient having metastatic status M1b and detecting presence or absence of one or more mutated Epidermal Growth Factor Receptor (EGFR) sequence in the blood sample from the NSCLC patient by allele-specific PCR; and (d) if the presence of an activating EGFR mutation selected from the group consisting of exon 19 deletion, L858R, L861Q, and G719X is detected, administering targeted drug therapy to the NSCLC patient, wherein the targeted drug therapy is an EGFR tyrosine kinase inhibitor.",
    "2. The method of claim 1, wherein the one or more mutated EGFR sequence comprises a resistance EGFR mutation selected from the group consisting of T790M, S678I and an exon 20 insertion.",
    "3. The method of claim 2, wherein the tyrosine kinase inhibitor is an irreversible tyrosine kinase inhibitor.",
    "4. The method of claim 1, wherein the tyrosine kinase inhibitor is erlotinib of gefitinib.",
    "5. The method of claim 1, wherein the presence or absence of one or more mutated EGFR sequence in the blood of the NSCLC patient subject is detected more than one time before, during, or after targeted drug therapy, or any combination thereof.",
    "6. The method of claim 5, increasing the dose of tyrosine kinase inhibitor administered to the NSCLC patient if an increase in quantity of the activating EGFR mutation selected from the group consisting of exon 19 deletion, L858R, L861Q, and G719X is detected.",
    "7. The method of claim 1, further comprising modifying the targeted drug therapy.",
    "8. The method of claim 2, further comprising modifying the targeted drug therapy.",
    "9. The method of claim 5, further comprising modifying the targeted drug therapy."
  ],
  "description_excerpt": "Germline and somatic mutations affecting various cell proliferation pathways are known to affect the development of cancer in patients. For example, the acquisition of somatic mutations that confer growth advantage on the cells possessing such mutations is considered an important factor in the emergence and progression of cancerous tumors. As a number of such mutations was identified, the therapies were developed that target the proteins encoded by the mutated genes, as well as the therapies targeting the signaling pathways in which these mutated genes are involved. As these targeted therapies were implemented into clinical practice, it was discovered that mutations conferring the resistance to the targeted therapies develop and accumulate in the patients' cancerous tumors, over time rendering the therapy ineffective and making it necessary to change the course of treatment.\n\nOne example of a solid tumor cancer in which somatic tumor mutations are known to play an important role is lung cancer, which is a leading cause of cancer-related mortality in many countries, including the United States. Approximately 75% of lung cancer cases belong to non-small cell lung cancer (NSCLC), which has an overall 5-year survival rate of approximately 12%. Standard surgical treatment, as well as chemotherapy and radiotherapies are available in the field of NSCLC. However, the majority of the NSCLC cases are initially diagnosed at the inoperable late stage, and relapse is common following surgery, chemotherapy, radiotherapy and other treatments. Accordingly, treatment and diagnosis of NSCLC is a challenging medical problem.",
  "cpc": [
    "C12Q 1/6886",
    "A61K 31/517",
    "A61K 31/5377",
    "C12Q 2600/106",
    "C12Q 2600/156"
  ],
  "ipc": [
    "A61K 31/517",
    "A61K 31/5377",
    "C12Q 1/68"
  ],
  "assignees": [
    "Aarhus Universitet",
    "Roche Molecular Systems Inc"
  ],
  "inventors": [
    "Peter Meldgaard",
    "Boe Sorensen",
    "Julie Tsai",
    "Wei Wen",
    "Lin Wu"
  ],
  "filing_date": "2016-04-13",
  "publication_date": "2018-03-13",
  "grant_date": "2018-03-13",
  "priority_date": "2013-03-08",
  "application_number": "US-201615098150-A",
  "family_id": "51569405",
  "cited_by_count": 2,
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}