Poziotinib combinations with an anti-her1, her2 or her4 antibody and methods of use thereof
AssigneesSpectrum Pharmaceuticals, Inc., Hanmi Pharmceutical Co., Ltd.
InventorsGuru Reddy, Sunyoung Jang, Jooyun Byun
Life of this patent
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Abstract
Provided are combinations of poziotinib and an anti-HER1, anti-HER2 or anti-HER4 antibody, optionally with other agents, and use of the combinations for treating cancer.
Claims33
A method of treating cancer in a subject, the method comprising administering to the subject therapeutically effective amounts of poziotinib and an anti-HER1, anti-HER2 or anti-HER4 antibody, cwherein the cancer is associated with overexpression or amplification of HER1, HER2, or HER4, or a mutant of HER1, HER2, or HER4, and
- wherein said cancer is non-small cell lung cancer, breast cancer, colon cancer, gastric cancer, pancreatic cancer, prostate cancer, myeloma, head cancer, neck cancer, ovarian cancer, esophageal cancer, or metastatic cell carcinoma.
A method of treating breast cancer in a subject in need thereof, wherein said breast cancer is associated with overexpression or amplification of HER2, or overexpression or amplification of a mutant of HER2, said method comprising the steps of:
- a) in a 21-day cycle±3 days:
- i) administering a single dose of T-DM1 ranging from 1.5-5.5 mg/kg;
- ii) administering a daily dose of poziotinib ranging from 0.5-50 mg/day;
- and
- iii) optionally resting from treatment for a period of time within the 21-day cycle;
- and
- b) optionally repeating said cycle, or a variation of said cycle.
17-19. (canceled)
A method of treating gastric cancer in a subject, the method comprising administering to the subject therapeutically effective amounts of poziotinib and an anti-HER1, anti-HER2 or anti-HER4 antibody,
- wherein the gastric cancer is associated with overexpression or amplification of HER1, HER2, or HER4, or a mutant of HER1, HER2, or HER4.
The method of claim 21, further comprising administering at least one agent selected from the group consisting of paclitaxel, cisplatin, 5-fluorouracil, vinorelbine, cetuximab and any combinations thereof.
A method of treating gastric cancer in a subject in need thereof, wherein said gastric cancer is associated with overexpression or amplification of HER2, or overexpression or amplification of a mutant of HER2, said method comprising the steps of:
- a) in a 21-day cycle±3 days:
- i) administering a single dose of trastuzumab ranging from 6-8 mg/kg;
- ii) administering a single dose of paclitaxel ranging from 105-175 mg/m2;
- and
- iii) administering a daily dose of poziotinib ranging from 4-16 mg/day;
- and
- b) optionally repeating said cycle.
35-37. (canceled)
Dependencies are inferred from the claim text.