Claims for Patent: 7,858,389

Summary for Patent: 7,858,389

Title:	Selection of non-small-cell lung cancer patients for treatment with monoclonal antibody drugs targeting EGFR pathway
Abstract:	Methods using mass spectral data analysis and a classification algorithm provide an ability to determine whether a non-small-cell lung cancer (NSCLC) patient is likely to benefit from a monoclonal antibody drug targeting an epidermal growth factor receptor pathway. A mass spectrum is obtained from a sample (e.g. blood sample) from the patient. One or more predefined pre-processing steps are performed on the mass spectrum. Values of selected features in the spectrum at one or more predefined m/z ranges are obtained after the pre-processing steps have been performed. Such values are used in a classification algorithm using a training set comprising class-labeled spectra produced from samples from other patients to identify the patient as being likely to benefit from treatment with the drug.
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:	12/321,392
Patent Claims:	1. A method of determining whether a non-small cell lung cancer (NSCLC) patient is likely to benefit from treatment with a monoclonal antibody drug targeting the EGFR pathway, comprising the steps of: a) obtaining a mass spectrum from a blood-based sample from the NSCLC patient; b) performing one or more predefined pre-processing steps on the mass spectrum obtained in step a); c) obtaining integrated intensity values of selected features in said spectrum at one or more predefined m/z ranges after the pre-processing steps on the mass spectrum in step b) have been performed; and d) using the values obtained in step c) in a classification algorithm using a training set comprising class-labeled spectra produced from blood-based samples from other cancer patients to identify the NSCLC patient as being either likely or not likely to benefit from treatment with the said monoclonal antibody drug targeting the EGFR pathway; wherein the said monoclonal antibody drug targeting the EGFR pathway is selected from the group of drugs consisting of cetuximab or the equivalent and panitumumab or the equivalent. 2. The method of claim 1, wherein the one or more 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. 3. The method of claim 1, wherein the mass spectrum is obtained from a MALDI mass spectrometer. 4. The method of claim 1, wherein the predefined pre-processing steps comprise a background subtraction step producing a background-subtracted spectrum, and a normalization step performing a normalization of the background-subtracted spectrum.

Details for Patent 7,858,389

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
Amgen, Inc.	VECTIBIX	panitumumab	Injection	125147	09/27/2006		2026-03-31