Claims for Patent: 10,232,040

Summary for Patent: 10,232,040

Title:	Anti-B7 H1 and anti-CTLA-4 antibodies for treating non-small cell lung cancer
Abstract:	Provided herein are methods of treating non-small cell lung cancers comprising administering an effective amount of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof.
Inventor(s):	Narwal; Rajesh (Gaithersburg, MD), Robbins; Paul (Gaithersburg, MD), Karakunnel; Joyson (Gaithersburg, MD), Dar; Mohammed (Gaithersburg, MD)
Assignee:	MEDIMMUNE, LLC (Gaithersburg, MD)
Application Number:	14/710,101
Patent Claims:	1. A method of treating non-small cell lung carcinoma (NSCLC) in a human patient, comprising administering 20 mg/kg of MEDI4736 or an antigen-binding fragment thereof and 1 mg/kg tremelimumab or an antigen-binding fragment thereof to the patient, wherein the MEDI4736 or an antigen-binding fragment thereof is administered about 1 hour following administration of tremelimumab or an antigen-binding fragment thereof, and wherein the MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof are administered every 4 weeks for at most 16 weeks. 2. The method of claim 1, further comprising administering 10 mg/kg of MEDI4736 or an antigen-binding fragment thereof every two weeks after 16 weeks. 3. The method of claim 2, wherein the total length of treatment is 52 weeks. 4. The method of claim 1, wherein the NSCLC is refractory to at least one chemotherapeutic agent prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 5. The method of claim 4, wherein the chemotherapeutic agent is Vemurafenib, Erlotinib, Afatinib, Cetuximab, Carboplatin, Bevacizumab, Erlotinib, Gefitinib, or Pemetrexed. 6. The method of claim 1, wherein the patient is immunotherapy-nave prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 7. The method of claim 1, wherein the administration of MEDI4736 or an antigen-binding fragment thereof is by intravenous infusion. 8. The method of claim 1, wherein the administration of tremelimumab or an antigen-binding fragment thereof is by intravenous infusion. 9. The method of claim 1, wherein the administrations reduce tumor size by at least about 10% relative to tumor size as measured prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 10. The method of claim 1, wherein the administrations reduce tumor size by at least about 25% or 50% relative to tumor size as measured prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 11. The method of claim 1, wherein the human patient has locally advanced unresectable or metastatic NSCLC. 12. The method of claim 11, wherein the NSCLC is squamous or non-squamous. 13. A method of treating non-small cell lung carcinoma (NSCLC) in a human patient, comprising administering 10 mg/kg of MEDI4736 or an antigen-binding fragment thereof and 1 mg/kg tremelimumab or an antigen-binding fragment thereof to the patient, wherein the MEDI4736 or an antigen-binding fragment thereof is administered about 1 hour following administration of tremelimumab or an antigen-binding fragment thereof, and wherein the MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof are administered every 4 weeks for at most 16 weeks. 14. The method of claim 13, further comprising administering 10 mg/kg of MEDI4736 or an antigen-binding fragment thereof every two weeks after 16 weeks. 15. The method of claim 14, wherein the total length of treatment is 52 weeks. 16. The method of claim 13, wherein the NSCLC is refractory to at least one chemotherapeutic agent prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 17. The method of claim 16, wherein the chemotherapeutic agent is Vemurafenib, Erlotinib, Afatinib, Cetuximab, Carboplatin, Bevacizumab, Erlotinib, Gefitinib, or Pemetrexed. 18. The method of claim 13, wherein the patient is immunotherapy-naive prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 19. The method of claim 13, wherein the administration of MEDI4736 or an antigen-binding fragment thereof is by intravenous infusion. 20. The method of claim 13, wherein the administration of tremelimumab or an antigen-binding fragment thereof is by intravenous infusion. 21. The method of claim 13, wherein the administrations reduce tumor size by at least about 10% relative to tumor size as measured prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 22. The method of claim 13, wherein the administrations reduce tumor size by at least about 25% or 50% relative to tumor size as measured prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 23. The method of claim 13, wherein the human patient has locally advanced unresectable or metastatic NSCLC. 24. The method of claim 23, wherein the NSCLC is squamous or non-squamous. 25. A method of treating non-small cell lung carcinoma (NSCLC) in a human patient, comprising administering 15 mg/kg of MEDI4736 or an antigen-binding fragment thereof and 1 mg/kg tremelimumab or an antigen-binding fragment thereof to the patient, wherein the MEDI4736 or an antigen-binding fragment thereof is administered about 1 hour following administration of tremelimumab or an antigen-binding fragment thereof, and wherein the MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof are administered every 4 weeks for at most 16 weeks. 26. The method of claim 25, further comprising administering 10 mg/kg of MEDI4736 or an antigen-binding fragment thereof every two weeks after 16 weeks. 27. The method of claim 26, wherein the total length of treatment is 52 weeks. 28. The method of claim 25, wherein the NSCLC is refractory to at least one chemotherapeutic agent prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 29. The method of claim 28, wherein the chemotherapeutic agent is Vemurafenib, Erlotinib, Afatinib, Cetuximab, Carboplatin, Bevacizumab, Erlotinib, Gefitinib, or Pemetrexed. 30. The method of claim 25, wherein the patient is immunotherapy-naive prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 31. The method of claim 25, wherein the administration of MEDI4736 or an antigen-binding fragment thereof is by intravenous infusion. 32. The method of claim 25, wherein the administration of tremelimumab or an antigen-binding fragment thereof is by intravenous infusion. 33. The method of claim 25, wherein the administrations reduce tumor size by at least about 10% relative to tumor size as measured prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 34. The method of claim 25, wherein the administrations reduce tumor size by at least about 25% or 50% relative to tumor size as measured prior to the administration of MEDI4736 or an antigen-binding fragment thereof and tremelimumab or an antigen-binding fragment thereof. 35. The method of claim 25, wherein the human patient has locally advanced unresectable or metastatic NSCLC. 36. The method of claim 35, wherein the NSCLC is squamous or non-squamous.

Details for Patent 10,232,040

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2034-05-13
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2034-05-13
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2034-05-13