COMBINATION OF IMMUNOMODULATORY AGENT WITH PD-1 or PD-L1 CHECKPOINT INHIBITORS IN THE TREATMENT OF CANCER
Methods for treating cancer include administering a therapeutically effective amount of an immunomodulatory agent such as interferon gamma 1b in combination with a therapeutically effective amount of a PD-1 checkpoint inhibitor such as nivolumab or pembrolizumab or a therapeutically effective amount of a PD-L1 checkpoint inhibitor.
1 . A method for treating cancer, comprising administering to a patient in need thereof
(a) a therapeutically effective amount of an immunomodulatory agent, and
(b) a therapeutically effective amount of a PD-1 checkpoint inhibitor and/or a therapeutically effective amount of PD-L1 checkpoint inhibitor.
2 . The method according to claim 1 , wherein the immunomodulatory agent is administered by itself during an induction phase that is prior to the administration of the PD-1 checkpoint inhibitor and/or the PD-L1 checkpoint inhibitor.
3 . The method according to claim 1 , wherein the PD-1 checkpoint inhibitor comprises an anti-PD-1 antibody.
4 . The method according to claim 3 , wherein the PD-1 checkpoint inhibitor is selected from nivolumab and pembrolizumab.
5 . The method according to claim 1 , wherein the PD-L1 checkpoint inhibitor comprises an anti-PD-L1 antibody.
6 . The method according to claim 5 , wherein the PD-L1 checkpoint inhibitor is selected from YW243.55.S70, MDX-1 105, MPDL3280A, and MEDI4736.
7 . The method according to claim 1 , comprising administering to a patient in need thereof (a) a therapeutically effective amount of an immunomodulatory agent, (b) a therapeutically effective amount of a PD-1 checkpoint inhibitor, and (c) a therapeutically effective amount of a PD-L1 checkpoint inhibitor.
8 . The method according to claim 1 , wherein the immunomodulatory agent comprises interferon gamma (IFN-γ) or interferon gamma 1b (IFN-γ 1b).
9 . The method according to claim 1 , wherein the patient is a human.
10 . The method according to claim 1 , wherein the cancer is a solid tumor cancer.
11 . The method according to claim 1 , wherein the cancer is selected from the group consisting of breast cancer, kidney cancer, esophageal cancer, ovarian cancer, urothelial carcinoma, renal cell carcinoma, genitourinary cancer, melanoma, non-small cell lung cancer, blood cancer, B cell lymphoma, Hodgkin's lymphoma, multiple myeloma, brain cancer, glioblastoma, glioma, meningioma, bladder cancer, cervical cancer, colorectal cancer, endometrial adenocarcinoma, gastrointestinal cancer, hepatocellular carcinoma, Merkel cell carcinoma, mesothelioma, microsatellite instability-high metastatic colorectal cancer, pancreatic cancer, prostate cancer, small cell lung cancer, and squamous cell cancer of the head and neck.
12 . A pharmaceutical composition, comprising: (a) a therapeutically effective amount of an immunomodulatory agent; and (b) a therapeutically effective amount of a PD-1 checkpoint inhibitor and/or a therapeutically effective amount of a PD-1 checkpoint inhibitor.
13 . The pharmaceutical composition according to claim 12 , wherein the PD-1 checkpoint inhibitor comprises an anti-PD-1 antibody.
14 . The pharmaceutical composition according to claim 13 , wherein the anti-PD-1 antibody is selected from nivolumab and pembrolizumab.
15 . The pharmaceutical composition according to claim 14 , wherein the anti-PD-1 antibody is nivolumab and at a fixed dose of 3.0 mg/kg.
16 . The pharmaceutical composition according to claim 14 , wherein the PD-L1 checkpoint inhibitor comprises an anti-PD-L1 antibody.
17 . The pharmaceutical composition according to claim 16 , wherein the anti-PD-L1 antibody is selected from YW243.55.S70, MDX-1 105, MPDL3280A, and MEDI4736.
18 . The pharmaceutical composition according to claim 12 , wherein the immunomodulatory agent comprises interferon gamma (IFN-γ) or interferon-gamma 1b (IFN-γ 1b).
19 . The pharmaceutical composition according to claim 18 , wherein the interferon-gamma 1b (IFN-γ 1b) is at a dose of at least about 30 mcg/m 2 , at least about 50 mcg/m 2 , at least about 75 mcg/m 2 , or at least about 100 mcg/m 2 .
20 . The pharmaceutical composition according to claim 12 , comprising: (a) a therapeutically effective amount of an immunomodulatory agent; (b) a therapeutically effective amount of a PD-1 checkpoint inhibitor, and (c) a therapeutically effective amount of a PD-1 checkpoint inhibitor.