Claims for Patent: 11,666,572

Summary for Patent: 11,666,572

Title:	Treatment of HER2 positive cancers
Abstract:	In one aspect, the present invention provides a method for treating or ameliorating the effects of a HER2 positive cancer in a subject. In some embodiments, the method comprises administering a combination therapy comprising an anti-HER2 antibody and tucatinib. In some embodiments, the method further comprises administering a chemotherapeutic agent (e.g., an antimetabolite) to the subject. Pharmaceutical compositions and kits are also provided herein.
Inventor(s):	Scott Peterson, Luke Walker
Assignee:	Cascadian Therapeutics Inc , Seagen Inc
Application Number:	US17/530,265
Patent Claims:	1. A method for treating a HER2-positive colorectal cancer in a human subject, the method comprising: administering a combination therapy comprising an anti-HER2 antibody and tucatinib, thereby treating the HER2-positive colorectal cancer. 2. The method of claim 1, wherein the anti-HER2 antibody is a member selected from the group consisting of trastuzumab, pertuzumab, ado-trastuzumab emtansine, margetuximab, and a combination thereof. 3. The method of claim 1, wherein the anti-HER2 antibody is trastuzumab. 4. The method of claim 3, wherein the trastuzumab is administered intravenously or subcutaneously. 5. The method of claim 3, wherein the trastuzumab is administered at an amount of about 6 mg to 8 mg per kg of the subject's body weight once every three weeks. 6. The method of claim 3, wherein the tucatinib is administered orally. 7. The method of claim 4, wherein the tucatinib is administered orally. 8. The method of claim 5, wherein the tucatinib is administered orally. 9. The method of claim 3, wherein the tucatinib is administered in an amount of about 300 mg twice per day. 10. The method of claim 4, wherein the tucatinib is administered in an amount of about 300 mg twice per day. 11. The method of claim 5, wherein the tucatinib is administered in an amount of about 300 mg twice per day. 12. The method of claim 3, wherein the HER2-positive colorectal cancer is an unresectable locally advanced colorectal cancer or a metastatic colorectal cancer. 13. The method of claim 9, wherein the HER2-positive colorectal cancer is an unresectable locally advanced colorectal cancer or a metastatic colorectal cancer. 14. The method of claim 3, wherein the HER2-positive colorectal cancer comprises a cell that has a wild-type KRAS exon 2 genotype, a wild-type NRAS genotype, or a wild-type BRAF genotype. 15. The method of claim 9, wherein the HER2-positive colorectal cancer comprises a cell that has a wild-type KRAS exon 2 genotype, a wild-type NRAS genotype, or a wild-type BRAF genotype. 16. The method of claim 3, wherein the subject has a HER2-positive colorectal cancer which is relapsed or refractory to a standard of care. 17. The method of claim 9, wherein the subject has a HER2-positive colorectal cancer which is relapsed or refractory to a standard of care. 18. The method of claim 3, wherein treating the subject results in a tumor growth inhibition (TGI) index of at least about 85%. 19. The method of claim 9, wherein treating the subject results in a tumor growth inhibition (TGI) index of at least about 85%. 20. The method of claim 3, wherein the combination of the trastuzumab and tucatinib is synergistic. 21. The method of claim 9, wherein the combination of the trastuzumab and tucatinib is synergistic. 22. The method of claim 1, wherein the anti-HER2 antibody is trastuzumab; wherein the trastuzumab is administered intravenously or subcutaneously at an amount of about 6 mg to 8 mg per kg of the subject's body weight once every three weeks; and wherein the tucatinib is administered orally in an amount of about 300 mg twice per day. 23. The method of claim 3, wherein the combination therapy further comprises a chemotherapeutic agent.