Patent SG-11201907211T-A (SG)
Title: Anti-pd-l1 antibody treatment of bladder cancer
Inventor: KURLAND JOHN
IPC: G01N33/574
Filed: 2018-02-16
Abstract: Astreated Population Initialed therapy..? days prior io data cutoff dates N =1012 Total 10 mglkg 02W Population N = 970' Dose --- F4 hglonFv* , 4.— , ...,,,loration Population N = 48 W O 20 18/ 152415 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 23 August 2018 (23.08.2018) WI PO I PCT 0111111010 0111 °nolo OH Kit mil °nova (10) International Publication Number WO 2018/152415 Al (51) International Patent Classification: A61K 39/00 (2006.01) C07K 16/30 (2006.01) A61K 39/395 (2006.01) GO1N 33/574 (2006.01) CO7K 16/28 (2006.01) (21) International Application Number: PCT/US2018/018513 (22) International Filing Date: 16 February 2018 (16.02.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/459,700 16 February 2017 (16.02.2017) US (71) Applicant: MEDIMMUNE, LLC [US/US]; One Medim- mune Way, Gaithersburg, MD 20878 (US). (72) Inventors: KURLAND, John; c/o Medimmune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). BLAKE-HASKINS, John, Andrew; c/o Medimmune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). ZAJAC, Magdalena; c/o Medimmune Limited, Mil- stein Building, Granta Park, Cambridge CB21 6GH (GB). REBELATTO, Marlon; c/o Medimmune, LLC, One Med- immune Way, Gaithersburg, MD 20878 (US). GUPTA, Ashok; c/o Medimmune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). HO, Tony; c/o Medim- mune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). WALKER, Jill; c/o Medimmune, LLC, Mil- stein Building, Granta Park, Cambridge CB21 6GH (GB). JIN, Xiaoping; c/o Medimmune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). MORRIS, Shannon; c/o Medimmune, LLC, One Medimmune Way, Gaithers- burg, MD 20878 (US). IANNONE, Robert; c/o Medim- mune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). SHI, Li; c/o Medimmune, LLC, One Med- immune Way, Gaithersburg, MD 20878 (US). DAR, Mo- hammed; c/o Medimmune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). BEN, Yong; c/o Medim- mune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). (74) Agent: MENSAH, Kwame, N. et al.; c/o Medimmune, LLC, One Medimmune Way, Gaithersburg, MD 20878 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, (54) Title: ANTI-PD-L1 ANTIBODY TREATMENT OF BLADDER CANCER (57) : Provided are methods of treating bladder cancer (e.g., urothe- lial carcinoma, UC) in a subject having bladder cancer, e.g., UC, with an effec- tive dose regimen of an anti-PD-L1 antibody, e.g., durvalumab, or an antigen binding fragment thereof. Also provided are methods in which an anti-PD-L1 antibody is used in combination with another immunotherapeutic agent, e.g., tremelimumab to treat a bladder cancer, e.g., UC, in a subject having bladder cancer. In some cases, the subject undergoing treatment is identified as having a bladder cancer or tumor that is PD-L1-low/neg, or PD-Ll-high. Methods are also provided in which anti-PD-L 1 antibody treatment of bladder cancer is used following a standard of care or first-line therapy in subjects who have progressed following such therapies or who have relapsed after a prior treatment regimen. Non-UC UC N=779 N=191 Primary Efficacy Populalion Initiated therapy> 13 weeks prior to data cutoff date Ne103 2L+ Post Platinum Treatment naivalL N = 94 N = 9 Osplatin ineligible Cisplabn eligible N e 7 N = 2 `The total 10 rngAtg 02W population included 6 subjects from the 10mglkg Q2W cohort in the dose-escalation phase. [Continued on next page] FIGURE 1 Total Number Patients Enrolled and Treated as of Data Cutoff Dates (29 April 2010 for non-UC; 24 July 2016 for UC) N 1022 WO 2018/152415 Al MIDEDIMOMOIDEIREEMOMOMMIVOMMin KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h))