Anti-FOLR1 Immunoconjugate Dosing Regimens
Methods of administering immunoconjugates that bind to FOLR1 are provided. The methods comprise administering an anti-FOLR1 immunoconjugate to a person in need thereof, for example, a cancer patient, at a therapeutically effective dosing regimen that results in minimal adverse effects.
1 . A method for treating a human patient having cancer comprising administering to the patient an effective dose of an immunoconjugate that binds to FOLR1 polypeptide, wherein the administration produces a Cmax of about 100-150 μg/mL.
2 . The method of claim 1 , wherein the immunoconjugate is administered at a dose of about 3 mg/kg to about 6 mg/kg.
3 .- 6 . (canceled)
7 . The method of claim 2 , wherein the immunoconjugate is administered at a dose of about 6.0 mg/kg.
8 . The method of claim 1 , wherein the immunoconjugate is administered at a dose of about 6.5 mg/kg.
9 . The method of claim 1 , wherein the immunoconjugate is administered about once every week.
10 . A method for treating a human patient having cancer comprising administering to the patient an effective dose of an immunoconjugate that binds to FOLR1 polypeptide, wherein the immunoconjugate is administered at a dose of about 6 mg/kg about once every week.
11 . A method for treating a human patient having cancer comprising administering to the patient an effective dose of an immunoconjugate that binds to FOLR1 polypeptide, wherein the immunoconjugate is administered at a dose of about 6.5 mg/kg about once every week.
12 . The method of claim 1 , wherein the immunoconjugate comprises an antibody comprising a light chain CDR1 comprising SEQ ID NO:6, a light chain CDR2 comprising SEQ ID NO:7, a light chain CDR3 comprising SEQ ID NO:8, a heavy chain CDR1 comprising SEQ ID NO:9, a heavy chain CDR2 comprising SEQ ID NO: 10 or 11, and a heavy chain CDR3 comprising SEQ ID NO: 12.
13 . The method of claim 12 , wherein the immunoconjugate comprises an antibody comprising a variable light chain comprising SEQ ID NO: 5 and a variable heavy chain comprising SEQ ID NO:3.
14 . (canceled)
15 . The method of claim 1 , wherein the immunoconjugate is administered intravenously.
16 . The method of claim 1 , wherein cancer is selected from the group consisting of ovarian, brain, breast, uterine, endometrial, pancreatic, renal, and lung cancer.
17 . The method of claim 16 , wherein the lung cancer is non small cell lung cancer or bronchioloalveolar carcinoma.
18 . The method of claim 16 , wherein the ovarian cancer is epithelial ovarian cancer.
19 . The method of claim 18 , wherein the ovarian cancer is platinum resistant, relapsed, or refractory.
20 . The method of claim 1 , wherein the cancer expresses FOLR1 polypeptide or nucleic acid.
21 . The method of claim 20 , wherein the FOLR1 expression levels are measured by immunohistochemistry (IHC).
22 . The method of claim 1 , further comprising administering a steroid to the patient.
23 . The method of claim 22 , wherein the steroid is dexamethasone.
24 . (canceled)
25 . The method of claim 1 , wherein the cancer is ovarian cancer and wherein the administration results in a decrease in CA125.
26 . The method of claim 1 , wherein the administration results in a decrease in adverse effects.