Claims for Patent: 7,906,342

Summary for Patent: 7,906,342

Title:	Monitoring treatment of 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. (Steamboat Springs, CO)
Application Number:	12/584,594
Patent Claims:	1. A method of facilitating treatment of a non-small cell lung cancer (NSCLC) 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 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 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 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 said one or more predefined 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 wherein the drug is selected from the group of drugs consisting of gefitinib or equivalent thereof; erlotinib or equivalent thereof and cetuximab or equivalent thereof. 2. The method of claim 1, wherein the patient is a male smoker or male ex-smoker. 3. The method of claim 1, wherein step 2) including sub-steps a)-d) are performed periodically during the course of treatment of the patient.

Details for Patent 7,906,342

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