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 an FOLR1-expressing cancer comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide, wherein the immunoconjugate is administered at a dose of about 3.0 to about 7 milligrams (mg) per kilogram (kg) of body weight of the patient, wherein the kilograms of body weight of the patient are adjusted to adjusted ideal body weight (AIBW).
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5 . The method of claim 1 , wherein the immunoconjugate is administered at a dose of about 5.0 mg/kg.
6 . The method of claim 1 , wherein the immunoconjugate is administered at a dose of about 6.0 mg/kg.
7 . The method of claim 1 , wherein the immunoconjugate is administered at a dose of about 6.5 mg/kg.
8 . The method of claim 1 , wherein the immunoconjugate is administered once every three weeks.
9 . The method of claim 1 , wherein the immunoconjugate is administered once every week.
10 . A method for treating a human patient having an FOLR1-expressing cancer comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide, wherein the immunoconjugate is administered at a dose of about 3.0 to about 7 milligrams (mg) per kilogram (kg) of body weight of the patient, and wherein the administration produces a Cmax of about 110-160 μg/mL.
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12 . A method for treating a human patient having an FOLR1-expressing cancer comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide, wherein the immunoconjugate is administered at a dose of about 3.0 to about 7 milligrams (mg) per kilogram (/kg) of body weight of the patient, and wherein the administration produces an AUC 0-24 of no more than 2700 hr·μg/mL.
13 . The method of claim 1 , wherein the immunoconjugate comprises an antibody or antigen-binding fragment thereof that comprises the CDRs of SEQ ID NOs: 6-9, 11, and 12.
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18 . The method of claim 1 , wherein the immunoconjugate is IMGN853.
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20 . The method of claim 1 , wherein said cancer is selected from the group consisting of ovarian, brain, breast, uterine, endometrial, pancreatic, renal, and lung cancer.
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33 . The method of claim 1 , wherein the administration results in a decrease in tumor size.
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36 . The method of claim 1 , wherein the administration results in decreased ocular toxicity.
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40 . A method for treating a human patient having an FOLR1-expressing cancer comprising administering to the patient an effective dose of an immunoconjugate which binds to FOLR1 polypeptide, wherein the administration produces an AUC 0-24 of no more than 2741 hr·μg/mL.
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68 . A method for treating a human patient having a FOLR1-expressing cancer comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide, wherein the immunoconjugate is administered once a week for three weeks on a four-week schedule.
69 . The method of claim 68 , wherein the immunoconjugate is administered on days 1, 8, and 15 of a four-week schedule.
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75 . The method of claim 68 , wherein the immunoconjugate is administered at a dose of about 1.5 to about 6 mg/kg.
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92 . A method for treating a human patient having an FOLR1-expressing cancer comprising administering to the patient an immunoconjugate which binds to FOLR1 polypeptide, wherein the immunoconjugate is administered at a dose of about 1 to about 7 milligrams (mg) per kilogram (kg) of body weight of the patient, wherein the kilograms of body weight of the patient are adjusted to adjusted ideal body weight and wherein the immunoconjugate is administered once a week for three weeks on a four-week schedule.
93 . The method of claim 92 , wherein the immunoconjugate is administered on days 1, 8, and 15 of the four-week schedule.
94 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 1.1 mg/kg.
95 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 1.8 mg/kg.
96 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 2.5 mg/kg.
97 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 3.3 mg/kg.
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128 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 2.8 mg/kg.
129 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 3.0 mg/kg.
130 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 3.75 mg/kg.
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133 . The method of claim 92 , wherein the immunoconjugate is administered at a dose of about 2.0 mg/kg.