US 12,447,150 B2
Treatment of cancer by combination of immune checkpoint inhibitor and folfirinox therapy
Keisuke Kimura, Osaka (JP); Masataka Kuroda, Osaka (JP); and Takeyuki Iwata, Osaka (JP)
Assigned to ONO PHARMACEUTICAL CO., LTD., Osaka (JP)
Appl. No. 17/297,339
Filed by ONO PHARMACEUTICAL CO., LTD., Osaka (JP)
PCT Filed Nov. 26, 2019, PCT No. PCT/JP2019/046048
§ 371(c)(1), (2) Date May 26, 2021,
PCT Pub. No. WO2020/111018, PCT Pub. Date Jun. 4, 2020.
Claims priority of application No. 2018-220866 (JP), filed on Nov. 27, 2018.
Prior Publication US 2022/0008421 A1, Jan. 13, 2022
Int. Cl. A61K 31/519 (2006.01); A61K 31/282 (2006.01); A61K 31/4745 (2006.01); A61K 31/513 (2006.01); A61K 39/395 (2006.01); A61P 35/00 (2006.01)
CPC A61K 31/519 (2013.01) [A61K 31/282 (2013.01); A61K 31/4745 (2013.01); A61K 31/513 (2013.01); A61K 39/3955 (2013.01); A61P 35/00 (2018.01)] 17 Claims
 
1. A method for suppressing the progression of, suppressing the recurrence of and/or treating pancreatic cancer or biliary tract cancer comprising administering nivolumab, as an active ingredient, in combination with FOLFIRINOX therapy or a dose-reducing regimen thereof to a subject in need thereof, wherein the administrating nivolumab does not include administrating nivolumab as a preoperative therapy, wherein the preoperative therapy is a preceding therapy with an anti-cancer drug prior to cancer resection surgery, and is performed for a purpose of preventing postoperative micrometastases of invasive cancer and preventing recurrence thereof, wherein nivolumab is administered at about 3 mg/kg body weight per dose or at about 240, 360, or 480 mg per dose about every 2 to 4 weeks, wherein the FOLFIRINOX therapy comprises administrations of oxaliplatin (L-OHP), irinotecan hydrochloride hydrate (CPT-11), levofolinate calcium (I-LV), and fluorouracil (5-FU), and wherein the dose-reducing regimen of the FOLFIRINOX therapy comprises a reduction of a dose of any of the L-OHP, CPT-11, I-LV, or 5-FU from the initial administration or in any of the administrations during the second and subsequent cycles of the FOLFIRINOX therapy.