Combination comprising palbociclib and 6-(2,4-dichlorophenyl)-5-[4-[(3s)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7h-benzo[7] annulene-2-carboxylic acid and its use for the treatment of cancer

Abstract

Herein are provided a combination of palbociclib and of 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid or a pharmaceutically acceptable salt thereof, a pharmaceutical composition containing such a combination, and the therapeutic uses thereof, in particular for the treatment of cancer, including breast cancer.

1 . A combination comprising 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and palbociclib. 
     
     
         2 . The combination according to  claim 1 , showing therapeutic synergy. 
     
     
         3 . The combination according to  claim 1 , for use in the treatment of cancer. 
     
     
         4 . The combination according to  claim 3 , wherein the cancer is breast cancer. 
     
     
         5 . A pharmaceutical composition comprising 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and palbociclib, and at least one pharmaceutically acceptable excipient. 
     
     
         6 . The pharmaceutical composition according to  claim 5 , wherein 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and palbociclib are administered simultaneously, separately, or spaced out over a period of time. 
     
     
         7 . The pharmaceutical composition according to  claim 5 , for use in the treatment of cancer. 
     
     
         8 . The pharmaceutical composition according to  claim 7 , wherein the cancer is breast cancer. 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . A pharmaceutical kit comprising:
 (i) a first pharmaceutical composition comprising 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient;   (ii) a second pharmaceutical composition comprising palbociclib, and at least one pharmaceutically acceptable excipient;   both pharmaceutical compositions (i) and (ii) being in separate compartments and being intended to be independently administered, each administration with regards to the other one being simultaneous, separated or spread out over time.