US2022280495A1PendingUtilityA1

Combination Therapy Including an MDM2 Inhibitor and One or More Additional Pharmaceutically Active Agents for the Treatment of Cancers

65
Assignee: AMGEN INCPriority: Nov 11, 2013Filed: Sep 9, 2021Published: Sep 8, 2022
Est. expiryNov 11, 2033(~7.3 yrs left)· nominal 20-yr term from priority
Inventors:Sean CaenepeelJude Robert CanonPaul HughesJonathan Daniel OlinerRichard J. RicklesAnne Y. Saiki
A61K 9/0053A61K 9/0019A61K 31/45A61P 13/10A61K 2300/00A61P 43/00A61P 35/02A61K 31/7068A61K 31/451A61K 31/706A61P 11/00A61P 1/16A61K 31/519A61K 31/437A61K 31/365A61K 31/44A61K 31/506A61K 31/4045A61K 31/166A61K 31/635A61K 31/7048A61K 31/704A61K 45/00A61K 31/4439A61K 31/5025A61K 31/496A61P 1/00A61P 35/00A61P 13/12A61P 17/00A61K 45/06
65
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Claims

Abstract

The present invention provides combination therapy that includes an MDM2 inhibitor and one or more additional pharmaceutically active agents, particularly for the treatment of cancers. The invention also relates to pharmaceutical compositions that contain an MDM2 inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers.

Claims

exact text as granted — not AI-modified
1 - 51 . (canceled) 
     
     
         52 . A method of treating chronic myeloid leukemia (CML), the method comprising administering to a patient in need thereof a therapeutically effective amount of 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid and dasatinib. 
     
     
         53 . A method of treating chronic myeloid leukemia (CML), the method comprising administering to a patient in need thereof a therapeutically effective amount of 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid and nilotinib. 
     
     
         54 . The method of  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered orally. 
     
     
         55 . The method of  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered orally. 
     
     
         56 . The method of  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is in a solid dosage form. 
     
     
         57 . The method of  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is in a solid dosage form. 
     
     
         58 . The method of  claim 56 , wherein the solid dosage form is a capsule. 
     
     
         59 . The method of  claim 57 , wherein the solid dosage form is a capsule. 
     
     
         60 . The method of  claim 56 , wherein the solid dosage form is a tablet. 
     
     
         61 . The method of  claim 57 , wherein the solid dosage form is a tablet. 
     
     
         62 . The method of  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered in a dosage in the range of about 0.01 to about 100 mg/kg body weight. 
     
     
         63 . The method of  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered in a dosage in the range of about 0.01 to about 100 mg/kg body weight. 
     
     
         64 . The method  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered in a dosage of 180 mg, 240 mg, or 300 mg QD. 
     
     
         65 . The method  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered in a dosage of 180 mg, 240 mg, or 300 mg QD. 
     
     
         66 . The method  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered before dasatinib. 
     
     
         67 . The method  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered after dasatinib. 
     
     
         68 . The method  claim 52 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered simultaneously with dasatinib. 
     
     
         69 . The method  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered before nilotinib. 
     
     
         70 . The method  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered after nilotinib. 
     
     
         71 . The method  claim 53 , wherein the compound 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid is administered simultaneously with nilotinib.

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