Claims for Patent: 8,119,418

Summary for Patent: 8,119,418

Title:	Monitoring treatment of colorectal cancer patients with drugs targeting EGFR pathway using mass spectrometry of patient samples
Abstract:	Methods using mass spectral data analysis and a classification algorithm provide an ability to determine whether a non-small-cell lung cancer patient, head and neck squamous cell carcinoma or colorectal cancer patient has likely developed a non-responsiveness to treatment with a drug targeting an epidermal growth factor receptor pathway. As the methods of this disclosure require only simple blood samples, the methods enable a fast and non-intrusive way of measuring when drugs targeting the EGFR pathway cease to be effective in certain patients. This discovery represents the first known example of true personalized selection of these types of cancer patients for treatment using these classes of drugs not only initially, but during the course of treatment.
Inventor(s):	Roder; Heinrich (Steamboat Springs, CO), Tsypin; Maxim (Steamboat Springs, CO), Grigorieva; Julia (Steamboat Springs, CO)
Assignee:	Biodesix, Inc. (Broomfield, CA)
Application Number:	12/931,324
Patent Claims:	1. A method of facilitating treatment of a colorectal cancer (CRC) patient comprising the steps of: 1) assigning a baseline class label for the patient using a classifier operating on integrated intensity values at pre-defined m/z ranges in mass-spectral data obtained from a first blood-based sample of the patient and a training set comprising class-labeled spectra from other patients, the baseline class label indicating whether the patient is likely to benefit from administration of a drug targeting an epidermal growth factor receptor pathway, wherein the drug consisting gefitinib or equivalent thereof, erlotinib or equivalent thereof, or cetuximab or equivalent thereof, wherein if the baseline class label is "good" (or the equivalent), the drug is administered to the patient; and 2) thereafter, while the patient is being treated with the drug, a) obtaining a mass spectrum of a second blood-based sample of the patient, b) performing one or more predefined pre-processing steps on the mass spectrum, c) obtaining integrated intensity values of selected features in said spectrum at one or more pre-defined m/z ranges after the pre-processing steps on the mass spectrum have been performed, and d) assigning a further class label for the sample using the classifier and the training set, the further class label indicating whether the patient has developed a non-responsiveness to the treatment with the said drug. 2. The method of claim 1, wherein step 2) including sub-steps a)-d) are performed periodically during the course of treatment of the patient. 3. The method of claim 1, wherein the one or more pre-defined m/z ranges comprises one or more m/z ranges selected from the group of m/z ranges consisting of: 5732 to 5795 5811 to 5875 6398 to 6469 11376 to 11515 11459 to 11599 11614 to 11756 11687 to 11831 11830 to 11976 12375 to 12529 23183 to 23525 23279 to 23622 and 65902 to 67502. 4. The method of claim 1, wherein the steps a)-d) are performed at intervals of between 30 and 100 days.

Details for Patent 8,119,418

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2026-03-31
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2026-03-31