Detection and treatment of CD30+ cancers

• US 10,444,241 B2
• Filed: 02/08/2013
• Issued: 10/15/2019
• Est. Priority Date: 02/10/2012
• Status: Active Grant

• Current Assignee: Seagen Inc.
• Original Assignee: Seattle Genetics Incorporated
• Inventors: Albertson, Tina, Smith, Maria L.
• Primary Examiner(s): Yao, Lei
• Application Number:
  US14/376,957
• Publication Number:
  US 20140377286A1
• Time in Patent Office: 2,440 Days
• Field of Search: None
• CPC Class Codes: A61K 47/6849 the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: C07K 16/2878 against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
• CPC Class Codes: G01N 2333/70578 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30 CD40 or CD95 NGF-receptor G01N2333/71, TNF-receptor G01N2333/7151
• CPC Class Codes: G01N 33/57492 involving compounds localized on the membrane of tumor or cancer cells

Abstract

The application provides methods of diagnosis, prognosis, prophylasxis and treatment of CD30⁺ cancers.

Claims

1. A method of identifying a patient as eligible for CD30-directed therapy and administering the CD30 directed therapy to a patient thereby identified as eligible, wherein the patient has ovarian serous carcinoma, triple negative breast cancer, pancreatic carcinoma, small cell lung cancer, anal squamous cell carcinoma, anaplastic thyroid carcinoma, genitourinary squamous cell carcinoma, Leydig cell tumor or Sertoli cell tumor, the method comprising fixing a tissue sample obtained from the patient, wherein the sample comprises cells of the cancer or carcinoma, contacting the fixed tissue sample with an anti-CD30 antibody, and detecting binding of the antibody to the fixed tissue sample to determine CD30 is expressed in the sample, and identifying the patient as eligible for CD30-directed therapy based on the expression of CD30 in at least 10% of the malignant or atypical cells of the cancer or carcinoma in the sample or for a patient with pancreatic cancer or small cell lung cancer at least 45% of the malignant or atypical cells of the cancer in the sample;

and administering the CD30-directed therapy to the patient identified as eligible, wherein the CD30 directed therapy is therapy with an anti-CD30 antibody conjugated to an auristatin or DNA minor groove binding agent.

2. The method of claim 1, wherein the tissue sample expresses CD30 and CD30 expression is determined as a percentage of tumor cells in the sample expressing detectable CD30.

3. The method of claim 1, further comprising determining a treatment protocol for the patient, wherein detectable expression of CD30 is an indication that the treatment protocol include treatment with the CD30-directed therapy.

4. The method of claim 1 wherein at least 50% of malignant or atypical cells in the sample express CD30 when using the anti-CD30 specific antibody BerH2 as the detection antibody.

5. The method of claim 1, wherein fixing the tissue sample comprises fixing the tissue sample with formalin and embedding the tissue sample in paraffin.

6. The method of claim 1, wherein the patient has an ovarian cancer.

7. The method of claim 1, wherein the patient has ovarian serous carcinoma, anal squamous cell carcinoma, anaplastic thyroid carcinoma, or genitourinary squamous cell carcinoma.

8. The method of claim 1, wherein the detecting determines CD30 is expressed in cell membranes and/or Golgi of cells of the ovarian serous carcinoma, triple negative breast cancer, pancreatic carcinoma, small cell lung cancer, anal squamous cell carcinoma, anaplastic thyroid carcinoma, or genitourinary squamous cell carcinoma of the sample.

9. The method of claim 1, wherein the patient has triple breast cancer, pancreatic carcinoma, small cell lung cancer, anal squamous cell carcinoma, anaplastic thyroid carcinoma, genitourinary squamous cell carcinoma, Leydig cell tumor or Sertoli cell tumor.