Claims for Patent: 10,478,494

Summary for Patent: 10,478,494

Title:	FGFR/PD-1 combination therapy for the treatment of cancer
Abstract:	Provided herein are combination therapies for the treatment of cancer. In particular, the disclosed methods are directed to treatment of cancer in a patient comprising administering an antibody that blocks the interaction between PD-1 and PD-L1 and an FGFR inhibitor, wherein the antibody that blocks the interaction between PD-1 and PD-L1 and the FGFR inhibitor are administered if one or more FGFR variants are present in a biological sample from the patient.
Inventor(s):	Jayaprakash Karkera, Suso Jesus PLATERO, Raluca Verona, Matthew V. Lorenzi
Assignee:	Janssen Pharmaceutica NV , Astex Therapeutics Ltd
Application Number:	US15/079,136
Patent Claims:	1. A method of treating cancer in a patient comprising: administering to the patient a pharmaceutically effective amount of an antibody that blocks the interaction between PD-1 and PD-L1; monitoring the efficacy of the antibody; and if the antibody is not efficacious, evaluating a biological sample from the patient for a presence of one or more FGFR variants, wherein the one or more FGFR variants comprise an FGFR fusion gene, and wherein the FGFR fusion gene is FGFR2:AFF3; FGFR2:BICC1; FGFR2:CASP7; FGFR2:CCDC6; FGFR2:OFD1; FGFR3:BAIAP2L1; FGFR3:TACC3-Intron; FGFR3:TACC3V1; FGFR3:TACC3V3; or a combination thereof; and administering to the patient a pharmaceutically effective amount of an FGFR inhibitor if the one or more FGFR variants are present in the sample, wherein the FGFR inhibitor is the compound of formula (I): or a pharmaceutically acceptable salt thereof. 2. The method of claim 1, wherein the evaluating step further comprises measuring an expression level of PD-L1 in a biological sample and wherein the second administering step comprises administering the FGFR inhibitor if: the biological sample has a PD-L1 expression corresponding to an H-score of about 0 to about 99; or the biological sample has a PD-L1 expression level that is lower than a reference PD-L1 expression level. 3. The method of claim 1 or 2, wherein the biological sample is blood, lymph fluid, bone marrow, a solid tumor sample, or any combination thereof. 4. The method of claim 1, wherein the cancer is lung cancer, bladder cancer, gastric cancer, breast cancer, ovarian cancer, head and neck cancer, esophageal cancer, glioblastoma, or any combination thereof. 5. The method of claim 4, wherein the lung cancer is non-small cell lung cancer (NSCLC) adenocarcinoma, NSCLC squamous cell carcinoma, small cell lung cancer, or any combination thereof. 6. The method of claim 1, wherein the one or more FGFR variants further comprise an FGFR mutation, an FGFR amplification, or a combination thereof. 7. The method of claim 1, wherein the antibody that blocks an interaction between PD-1 and PD-L1 is an anti-PD-1 antibody, an anti-PD-L1 antibody, or a combination thereof. 8. The method of claim 2, wherein the cancer is lung cancer, bladder cancer, gastric cancer, breast cancer, ovarian cancer, head and neck cancer, esophageal cancer, glioblastoma, or any combination thereof. 9. The method of claim 8, wherein the lung cancer is non-small cell lung cancer (NSCLC) adenocarcinoma, NSCLC squamous cell carcinoma, small cell lung cancer, or any combination thereof. 10. The method of claim 2, wherein the one or more FGFR variants further comprise an FGFR mutation, an FGFR amplification, or a combination thereof. 11. The method of claim 2, wherein the antibody that blocks an interaction between PD-1 and PD-L1 is an anti-PD-1 antibody, an anti-PD-L1 antibody, or a combination thereof. 12. The method of claim 3, wherein the cancer is lung cancer, bladder cancer, gastric cancer, breast cancer, ovarian cancer, head and neck cancer, esophageal cancer, glioblastoma, or any combination thereof. 13. The method of claim 12, wherein the lung cancer is non-small cell lung cancer (NSCLC) adenocarcinoma, NSCLC squamous cell carcinoma, small cell lung cancer, or any combination thereof. 14. The method of claim 3, wherein the one or more FGFR variants further comprise an FGFR mutation, an FGFR amplification, or a combination thereof. 15. The method of claim 3, wherein the antibody that blocks an interaction between PD-1 and PD-L1 is an anti-PD-1 antibody, an anti-PD-L1 antibody, or a combination thereof. 16. The method of claim 1, wherein the biological sample: has a PD-L1 expression corresponding to an H-score of less than 20; or has a PD-L1 expression level that is lower than a reference PD-L1 expression level. 17. The method of claim 16, where the biological sample has a PD-L1 expression corresponding to an H-score of less than 20.