COMBINATION OF REGORAFENIB AND PD-1/PD-L1(2) INHIBITORS FOR TREATING CANCER
The present invention relates to pharmaceutical compositions and combinations comprising regorafenib or its hydrate, solvate, metabolite or pharmaceutically acceptable salt or a polymorph thereof and a PD-1/PD-L1(2) inhibitor for treating, preventing or managing diseases and conditions including hyperproliferative disorders such as cancer in humans and other mammals.
1 - 11 . (canceled)
12 . A pharmaceutical combination comprising regorafenib or its hydrate, solvate, metabolite or pharmaceutically acceptable salt, or a polymorph thereof and pembrolizumab.
13 . The combination of claim 12 which is a combination pack containing the components separate from one another.
14 . The combination of claim 12 wherein the components are in separate dosage forms for administration simultaneously or sequentially for use in the treatment of the same disease in a subject.
15 . The combination of claim 14 wherein the regorafenib dosage form is for administration first followed by the administration of the pembrolizumab dosage form.
16 . The combination of claim 12 wherein regorafenib is in an oral dosage form and pembrolizumab is in an intravenous dosage form.
17 . The combination of claim 12 wherein regorafenib is in the form of a tablet and pembrolizumab is in an intravenous dosage form.
18 . The combination of claim 12 wherein regorafenib is in a dosage form in an amount of 10 to 100 mg.
19 . The combination of claim 12 which is in the form of a medicament for treating hyper-proliferative disorders.
20 . The combination of claim 19 wherein the hyper-proliferative disorders are selected from the group consisting of cancers of the breast, respiratory tract, brain, reproductive organs, digestive tract, urinary tract, eye, liver, skin, head and neck, thyroid, parathyroid and their distant metastases.
21 . The combination of claim 19 wherein the hyper-proliferative disorders are selected from the group consisting of hepatic cell cancer, colorectal cancer and gastrointestinal stromal tumors (GIST).
22 . The combination of claim 19 wherein the hyper-proliferative disorder is hepatic cell cancer.
23 . The combination of claim 19 wherein the hyper-proliferative disorder is colorectal cancer.
24 . A method of treating hyper-proliferative disorders in a subject in need thereof comprising administering effective amounts of regorafenib or its hydrate, solvate, metabolite or pharmaceutically acceptable salt, or a polymorph thereof and pembrolizumab.
25 . The method of claim 24 wherein regorafenib is administered first followed by the administration of pembrolizumab.
26 . The method of claim 24 wherein regorafenib is administered orally and pembrolizumab is administered intravenously.
27 . The method of claim 24 wherein regorafenib is administered in the form of a tablet and pembrolizumab is administered intravenously.
28 . The method of claim 24 wherein the hyper-proliferative disorders are selected from the group consisting of cancers of the breast, respiratory tract, brain, reproductive organs, digestive tract, urinary tract, eye, liver, skin, head and neck, thyroid, parathyroid and their distant metastases.
29 . The method of claim 24 wherein the hyper-proliferative disorders are selected from the group consisting of hepatic cell cancer, colorectal cancer and gastrointestinal stromal tumors (GIST).
30 . The method of claim 24 wherein the hyper-proliferative disorder is hepatic cell cancer.
31 . The method of claim 24 wherein the hyper-proliferative disorder is colorectal cancer.