Claims for Patent: 10,016,484

Summary for Patent: 10,016,484

Title:	Methods of treating lung cancer
Abstract:	Methods of treating cancers comprising FGFR1 gene amplification are provided. In some embodiments, the methods comprise administering a fibroblast growth factor receptor 1 (FGFR1) extracellular domain (ECD) and/or an FGFR1 ECD fusion molecule. In some embodiments, the methods comprise administering a fibroblast growth factor receptor 1 (FGFR1) extracellular domain (ECD) and/or an FGFR1 ECD fusion molecule in combination with at least one additional therapeutic agent.
Inventor(s):	Harding; Thomas (San Francisco, CA), Palencia; Servando (San Francisco, CA), Long; Li (Lafayette, CA), Hestir; Kevin (Kensington, CA)
Assignee:	FIVE PRIME THERAPEUTICS, INC. (South San Francisco, CA)
Application Number:	14/357,336
Patent Claims:	1. A method of treating lung cancer having an FGFR1 gene amplification in a subject, wherein the cancer overexpresses fibroblast growth factor 2 (FGF2), and wherein at least a portion of the cells of the lung cancer have a ratio of FGFR1 gene to chromosome 8 centromere of at least 1.5, and wherein the FGFR1 gene amplification is indicative of therapeutic responsiveness by the lung cancer to a fibroblast growth factor receptor 1 (FGFR1) extracellular domain (ECD) or an FGFR1 ECD fusion molecule, comprising: administering a therapeutically effective amount of an FGFR1 ECD or an FGFR1 ECD fusion molecule to the subject. 2. The method of claim 1, wherein, prior to administration of the FGFR1 ECD or FGFR1 ECD fusion molecule, at least a portion of the cells of the lung cancer have been determined to have a ratio of FGFR1 gene to chromosome 8 centromere of at least 1.5. 3. The method of claim 1, wherein at least a portion of the cells of the lung cancer having an FGFR1 gene amplification comprise at least three copies of the FGFR1 gene. 4. The method of claim 2, wherein FGFR1 gene amplification was determined by a method selected from fluorescence in situ hybridization, array comparative genomic hybridization, DNA microarray, spectral karyotyping, quantitative PCR, southern blotting, or sequencing. 5. The method of claim 1, wherein the lung cancer further overexpresses at least one marker selected from FGFR1, FGFR3IIIc, DKK3, FGF18, and ETV4. 6. The method of claim 5, wherein the lung cancer overexpresses FGFR1IIIc, wherein FGFR1IIIc is a species of FGFR1. 7. A method of treating lung cancer that overexpresses FGF2 in a subject, wherein overexpression of FGF2 is indicative of therapeutic responsiveness by the lung cancer to a fibroblast growth factor receptor 1 (FGFR1) extracellular domain (ECD) or an FGFR1 ECD fusion molecule, comprising: administering a therapeutically effective amount of an FGFR1 ECD or an FGFR1 ECD fusion molecule to the subject. 8. The method of claim 7, wherein, prior to administration of the FGFR1 ECD or FGFR1 ECD fusion molecule, at least a portion of the cells of the lung cancer have been determined to overexpress FGF2. 9. The method of claim 7, wherein the lung cancer overexpresses at least one additional marker selected from FGFR3IIIc, DKK3, FGF18, and ETV4. 10. The method of claim 7, wherein the lung cancer does not have an FGFR1 gene amplification. 11. The method of claim 7, wherein the overexpression is protein overexpression. 12. The method of claim 7, wherein the overexpression is mRNA overexpression. 13. The method of claim 1, wherein the method further comprises administering at least one additional therapeutic agent. 14. The method of claim 13, wherein at least one additional therapeutic agent is selected from docetaxel, paclitaxel, vincristine, carboplatin, cisplatin, oxaliplatin, doxorubicin, 5-fluorouracil (5-FU), leucovorin, pemetrexed, etoposide, topotecan, sorafenib, a VEGF antagonist, a VEGF trap, an anti-VEGF antibody, and bevacizumab. 15. The method of claim 1, wherein the method comprises administering an FGFR1 ECD. 16. The method of claim 15, wherein the FGFR1 ECD comprises an amino acid sequence selected from SEQ ID NOs: 1 to 4. 17. The method of claim 1, wherein the method comprises administering an FGFR1 ECD fusion molecule. 18. The method of claim 17, wherein the FGFR1 ECD fusion molecule comprises an FGFR1 ECD and a fusion partner, and wherein the fusion partner is Fc. 19. The method of claim 18, wherein the FGFR1 ECD fusion molecule comprises a sequence selected from SEQ ID NO: 5 and SEQ ID NO: 6. 20. A method of treating lung cancer in a subject, wherein the cancer has an FGFR1 gene amplification and an FGF2 overexpression, the method comprising: determining in a lung cancer sample from the subject that at least a portion of the cells of the sample have a ratio of FGFR1 gene to chromosome 8 centromere of at least 1.5, and that at least a portion of the cells of the sample overexpress FGF2 mRNA or FGF2 protein, and administering a therapeutically effective amount of an FGFR1 ECD or an FGFR1 ECD fusion molecule to the subject for whom at least a portion of the cells of the sample are determined to have FGFR1 gene amplification and FGF2 overexpression.

Details for Patent 10,016,484

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2031-11-14