Claims for Patent: 10,154,998

Summary for Patent: 10,154,998

Title:	Therapies for hematologic malignancies
Abstract:	The invention provides methods that relate to a novel therapeutic strategy for the treatment of hematological malignancies and inflammatory diseases. In particular, the method comprises administering a compound of formula A, ##STR00001## wherein R is H, halo, or C1-C6 alkyl; R\' is C1-C6 alkyl; or a pharmaceutically acceptable salt thereof; and optionally a pharmaceutically acceptable excipient; and administering at least one additional therapeutic agent.
Inventor(s):	Gallatin; W. Michael (Mercer Island, WA), Ulrich; Roger G. (Sammamish, WA), Giese; Neill A. (San Francisco, CA), Lannutti; Brian (San Diego, CA), Miller; Langdon (Seattle, WA), Jahn; Thomas M. (Emerald Hills, CA)
Assignee:	Gilead Calistoga LLC (Foster City, CA)
Application Number:	15/277,857
Patent Claims:	1. A method for treating a hematological malignancy in a subject in need thereof, comprising administering a compound of formula A, ##STR00017## wherein R is halo; R' is C1-C6 alkyl; or a pharmaceutically acceptable salt thereof; and optionally a pharmaceutically acceptable excipient; and ofatumumab, wherein said hematological malignancy is chronic lymphocytic leukemia (CLL) or acute lymphocytic leukemia (ALL). 2. The method according to claim 1, wherein the compound is predominantly the S-enantiomer. 3. The method according to claim 1, wherein R is fluoro (F) and is attached to position 5 or 6 of the quinazolinyl ring. 4. The method according to claim 1, wherein R is F; and R' is methyl, ethyl or propyl. 5. The method according to claim 1, wherein the compound is a compound of formula I'' ##STR00018## 6. The method according to claim 1, further comprising administering at least one additional therapeutic agent. 7. The method according to claim 1, wherein the subject is refractory to chemotherapy treatment or is in relapse after treatment with chemotherapy. 8. The method according to claim 1, comprising administering to said subject a pharmaceutical composition comprising the compound of formula A or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient. 9. A method for treating a hematological malignancy in a subject in need thereof, comprising administering a compound of formula I'' ##STR00019## or a pharmaceutically acceptable salt thereof, and ofatumumab, wherein said hematological malignancy is chronic lymphocytic leukemia (CLL) or acute lymphocytic leukemia (ALL). 10. The method according to claim 9, wherein the subject is refractory to chemotherapy treatment or is in relapse after treatment with chemotherapy. 11. The method according to claim 9, further comprising administering at least one additional therapeutic agent. 12. The method according to claim 9, comprising administering to said subject a pharmaceutical composition comprising the compound of formula I'' or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient. 13. The method according to claim 9, wherein said subject has at least one enlarged lymph node. 14. The method according to claim 10, wherein said subject is refractory to at least two standard or experimental chemotherapy treatments. 15. The method according to claim 9, wherein said compound of formula I'' or a pharmaceutically acceptable salt thereof is administered at a dose of 50-350 mg BID. 16. The method according to claim 15, wherein said compound of formula I'' or a pharmaceutically acceptable salt thereof is administered at a dose of 150 mg BID.

Details for Patent 10,154,998

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	10/26/2009		2028-11-13
Novartis Pharmaceuticals Corporation	ARZERRA	ofatumumab	Injection	125326	04/01/2011		2028-11-13
Novartis Pharmaceuticals Corporation	KESIMPTA	ofatumumab	Injection	125326	08/20/2020		2028-11-13