Non-adult human dosing of anti-cd30 antibody-drug conjugates
AssigneeMillennium Pharmaceuticals, Inc.
InventorAdedigbo FASANMADE
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Abstract
The invention provides, inter alia, methods of treating a disorder characterized by pathological activity of CD30+ cells, such as in certain solid, hematological and lymphoid cancers, in a non-adult human subject by administering an effective amount of an anti-CD30 ADC (antibody drug conjugate), such as, brentuximab vedotin, to the subject. The invention also provides corresponding kits and articles of manufacture suitable for performing the methods provided by the invention.
Claims16
A method of treating a hematological or lymphoid cancer in a non-adult human subject comprising administering one or more doses of an anti-CD30 antibody-drug conjugate (ADC) at a body surface area-adjusted dose.
The method of any one of the preceding claims wherein the anti-CD30 antibody-drug conjugate (ADC) is administered at a dose of about 71.5 mg/m2, about 48 mg/m2, or about 36 mg/m2.
The method of any one of the preceding claims, wherein the subject is undergoing concurrent chemotherapy, such as AVD (adriamycin, vinblastine, dacarbazine), or CHP (doxorubicin, cyclophosphamide, prednisone);
- immunotherapy (such as nivolumab);
- HSC (hematopoietic stem cell) transplant therapy;
- radio therapy;
- or a combination thereof.
The method of any one of the preceding claims, wherein the subject's normalized drug expose as measured by area under the ADC concentration time curve (AUC) is substantially similar to an adult AUC for an indicated adult dose.
The method of any one of the preceding claims, wherein the ADC comprises an anti-CD30 antibody comprising the complementarity determining regions (CDRs) of cAC10.
The method of any one of the preceding claims, wherein the ADC comprises the anti-CD30 antibody cAC10.
The method of any one of the preceding claims, wherein the ADC comprises an auristatin.
The method of any one of the preceding claims, wherein the ADC comprises a cathepsin cleavable linker, optionally including a spacer.
The method of any one of the preceding claims, wherein the ADC is brentuximab vedotin.
The method of any one of the preceding claims, wherein the ADC is administered for more than one cycle, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20, or more, cycles, e.g., once every one, two, three, four, five, or six weeks, e.g., once every two or three weeks.
An article of manufacture comprising an anti-CD30 antibody-drug conjugate (ADC) at a body surface-area adjusted dose suitable for treating a non-adult human subject, e.g., for treating a hematological or lymphoid cancer.
A method of treating a hematological or lymphoid cancer in a non-adult human subject comprising administering one or more doses of brentuximab vedotin to the subject at a dose of between about:
- 32-78 mg/m2, e.g.:
- about:
- 64-78 mg/m2, e.g. between about:
- 66-76 mg/m2, 68-74 mg/m2, 70-72 mg/m2, or about 71.5 mg/m2, e.g., every three weeks;
- or, e.g.,
- about:
- 43-53 mg/m2, e.g. between about:
- 45-51 mg/m2, 47-49 mg/m2 or about 48 mg/m2, e.g., every two weeks, or, e.g.,
- about 32-40 mg/m2, e.g. between about:
- 34-38, 35-37, or about 36 mg/m2, e.g. about every two weeks.
Brentuximab vedotin for treating a hematological or lymphoid cancer in a non-adult human subject, wherein the brentuximab vedotin is provided at a dose of between about:
- 32-78 mg/m2, e.g.:
- about:
- 64-78 mg/m2, e.g. between about:
- 66-76 mg/m2, 68-74 mg/m2, 70-72 mg/m2, or about 71.5 mg/m2, e.g., every three weeks;
- or, e.g.,
- about:
- 43-53 mg/m2, e.g. between about:
- 45-51 mg/m2, 47-49 mg/m2 or about 48 mg/m2, e.g., every two weeks, or, e.g.,
- about 32-40 mg/m2, e.g. between about:
- 34-38, 35-37, or about 36 mg/m2, e.g. about every two weeks.
Dependencies are inferred from the claim text.