US2019192655A1PendingUtilityA1

Methods of treatment with antagonists against pd-1 and pd-l1 in combination with radiation therapy

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Assignee: MEDIMMUNE LTDPriority: Jun 17, 2014Filed: Sep 5, 2018Published: Jun 27, 2019
Est. expiryJun 17, 2034(~7.9 yrs left)· nominal 20-yr term from priority
Inventors:Ross Anthony StewartMichelle MorrowRobert WilkinsonEdmund PoonSimon DovediTim Illidge
A61P 43/00A61P 35/02A61P 35/00A61K 39/3955C07K 16/2818A61K 39/39558C07K 16/2827A61N 5/10C07K 2317/73A61K 2039/505A61K 2300/00A61K 39/395
45
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Claims

Abstract

This application provides a method of treating cancer in a patient comprising administering at least one dose of radiation therapy and at least one PD-1 and/or PD-L1 antagonist, wherein at least one PD-1 and/or PD-L1 antagonist is administered on the same day as a dose of radiation therapy or up to and including 4 days later.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 - 20 . (canceled) 
     
     
         21 . A method of treating lung cancer in a patient comprising:
 a. administering to the patient radiation therapy that includes a fraction of fractionated radiation therapy; and   b. administering to the patient at least one PD-1 and/or PD-L1 antagonist, wherein the at least one PD-1 and/or PD-L1 antagonist is administered on the same day as the last fraction of radiation therapy or up to and including 42 days later, wherein the fraction is 2.2 Gy or lower.   
     
     
         22 . The method of  claim 21 , where in the at least one PD-1 and/or PD-L1 antagonist is administered on the same day as the last fraction of radiation therapy or up to and including 14 days later. 
     
     
         23 . The method of  claim 21 , wherein the patient is administered fractions of radiation therapy that total about 70 Gy or lower. 
     
     
         24 . The method of  claim 23 , wherein the patient is administered fractions of radiation therapy that total about 50 Gy or lower. 
     
     
         25 . The method of  claim 21 , wherein the radiation therapy fractions are administered on sequential days. 
     
     
         26 . The method of  claim 21 , wherein the at least one PD-1 and/or PD- antagonist is administered on day 1. 
     
     
         27 . The method of  claim 21 , wherein the at least one PD-1 and/or PD-L1 antagonist is administered multiple times. 
     
     
         28 . A method of treating bladder cancer in a patient comprising:
 a. administering to the patient radiation therapy that includes a fraction of fractionated radiation therapy; and   b. administering to the patient at least one PD-1 and/or PD-L1 antagonist, wherein the at least one PD-1 and/or PD-L1 antagonist is administered on the same day as the last fraction of radiation therapy or up to and including 42 days later, wherein the fraction is 2.2 Gy or lower.   
     
     
         29 . The method of  claim 28 , where in the at least one PD-1 and/or PD-L1 antagonist is administered on the same day as the last fraction of radiation therapy or up to and including 14 days later. 
     
     
         30 . The method of  claim 28 , wherein the patient is administered fractions of radiation therapy that total about 70 Gy or lower. 
     
     
         31 . The method of  claim 30 , wherein the patient is administered fractions of radiation therapy that total about 50 Gy or lower. 
     
     
         32 . The method of  claim 28 , wherein the radiation therapy fractions are administered on sequential days. 
     
     
         33 . The method of  claim 28 , wherein the at least one PD-1 and/or PD-L1 antagonist is administered on day 1. 
     
     
         34 . The method of  claim 28 , wherein the at least one PD-1 and/or PD-L1 antagonist is administered multiple times. 
     
     
         35 . A method of treating head and neck cancer in a patient comprising:
 a. administering to the patient radiation therapy that includes a fraction of fractionated radiation therapy; and   b. administering to the patient at least one PD-1 and/or PD-L1 antagonist, wherein the at least one PD-1 and/or PD-L1 antagonist is administered on the same day as the last fraction of radiation therapy or up to and including 42 days later, wherein the fraction is 2.2 Gy or lower.   
     
     
         36 . The method of  claim 35 , where in the at least one PD-1 and/or PD-L1 antagonist is administered on the same day as the last fraction of radiation therapy or up to and including 14 days later. 
     
     
         37 . The method of  claim 35 , wherein the patient is administered fractions of radiation therapy that total about 70 Gy or lower. 
     
     
         38 . The method of  claim 37 , wherein the patient is administered fractions of radiation therapy that total about 50 Gy or lower. 
     
     
         39 . The method of  claim 35 , wherein the radiation therapy fractions are administered on sequential days. 
     
     
         40 . The method of  claim 35 , wherein the at least one PD-1 and/or PD-L1 antagonist is administered on day 1. 
     
     
         41 . The method of  claim 35 , wherein the at least one PD-1 and/or PD-L1 antagonist is administered multiple times. 
     
     
         42 . A method of treating lung cancer in a patient comprising:
 a. administering to the patient radiation therapy that includes a fraction of fractionated radiation therapy; and   b. administering to the patient at least one PD-1 and/or PD-L1 antibody or functional part thereof, wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on the same day as the last fraction of radiation therapy or up to and including 42 days later, wherein the fraction is 2.2 Gy or lower.   
     
     
         43 . The method of  claim 42 , where in the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on the same day as the last fraction of radiation therapy or up to and including 14 days later. 
     
     
         44 . The method of  claim 42 , wherein the patient is administered fractions of radiation therapy that total about 70 Gy or lower. 
     
     
         45 . The method of  claim 44 , wherein the patient is administered fractions of radiation therapy that total about 50 Gy or lower. 
     
     
         46 . The method of  claim 42 , wherein the radiation therapy fractions are administered on sequential days. 
     
     
         47 . The method of  claim 42 , wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on day 1. 
     
     
         48 . The method of  claim 42 , wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered multiple times. 
     
     
         49 . The method of  claim 42 , wherein the anti-PD-1 and/or PD-L1 antibody or functional part thereof is MEDI4736. 
     
     
         50 . The method of  claim 42 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is pembrolizumab. 
     
     
         51 . The method of  claim 42 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is nivolumab. 
     
     
         52 . The method of  claim 42 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is MPDL3280A. 
     
     
         53 . A method of treating bladder cancer in a patient comprising:
 a. administering to the patient radiation therapy that includes a fraction of fractionated radiation therapy; and   b. administering to the patient at least one PD-1 and/or PD-L1 antibody or functional part thereof, wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on the same day as the last fraction of radiation therapy or up to and including 42 days later, wherein the fraction is 2.2 Gy or lower.   
     
     
         54 . The method of  claim 53 , where in the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on the same day as the last fraction of radiation therapy or up to and including 14 days later. 
     
     
         55 . The method of  claim 53 , wherein the patient is administered fractions of radiation therapy that total about 70 Gy or lower. 
     
     
         56 . The method of  claim 55 , wherein the patient is administered fractions of radiation therapy that total about 50 Gy or lower. 
     
     
         57 . The method of  claim 53 , wherein the radiation therapy fractions are administered on sequential days. 
     
     
         58 . The method of  claim 53 , wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on day 1. 
     
     
         59 . The method of  claim 53 , wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered multiple times. 
     
     
         60 . The method of  claim 53 , wherein the anti-PD-1 and/or PD-L1 antibody or functional part thereof is MEDI4736. 
     
     
         61 . The method of  claim 53 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is pembrolizumab. 
     
     
         62 . The method of  claim 53 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is nivolumab. 
     
     
         63 . The method of  claim 53 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is MPDL3280A. 
     
     
         64 . A method of treating head and neck cancer in a patient comprising:
 a. administering to the patient radiation therapy that includes a fraction of fractionated radiation therapy; and   b. administering to the patient at least one PD-1 and/or PD-L1 antibody or functional part thereof, wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on the same day as the last fraction of radiation therapy or up to and including 42 days later, wherein the fraction is 2.2 Gy or lower.   
     
     
         65 . The method of  claim 64 , where in the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on the same day as the last fraction of radiation therapy or up to and including 14 days later. 
     
     
         66 . The method of  claim 64 , wherein the patient is administered fractions of radiation therapy that total about 70 Gy or lower. 
     
     
         67 . The method of  claim 66 , wherein the patient is administered fractions of radiation therapy that total about 50 Gy or lower. 
     
     
         68 . The method of  claim 64 , wherein the radiation therapy fractions are administered on sequential days. 
     
     
         69 . The method of  claim 64 , wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered on day 1. 
     
     
         70 . The method of  claim 64 , wherein the at least one PD-1 and/or PD-L1 antibody or functional part thereof is administered multiple times. 
     
     
         71 . The method of  claim 64 , wherein the anti-PD-1 and/or PD-L1 antibody or functional part thereof is MEDI4736. 
     
     
         72 . The method of  claim 64 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is pembrolizumab. 
     
     
         73 . The method of  claim 64 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is nivolumab. 
     
     
         74 . The method of  claim 64 , wherein the anti-PD-1 and/or anti-PD-L1 antibody or functional part thereof is MPDL3280A.

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