Weekly dosing regimens for anti-CD30 vc-PAB-MMAE antibody drug-conjugates
Methods for the treatment of CD30-expressing cancers are provided. The methods comprise administering to a subject in need thereof a weekly dose of from about 0.8 mg/kg to about 1.8 mg/kg of an antibody-drug conjugate compound having formula (I); or a pharmaceutically acceptable salt thereof; wherein: mAb is an anti-CD30 antibody unit, S is a sulfur atom of the antibody, A- is a Stretcher unit, and p is from about 3 to about 5.
1. A method for treating a CD30-expressing hematologic cancer in a human subject, the method comprising administering to a human subject in need thereof a dose of a pharmaceutical composition comprising (i) cAC10-MC-vc-PAB-MMAE antibody-drug conjugate, and (ii) a pharmaceutically acceptable carrier, wherein the administered dose of cAC10-MC-vc-PAB-MMAE antibody-drug conjugate is 1.8 mg/kg of the human subject's body weight and the pharmaceutical composition is administered every three weeks, wherein the pharmaceutical composition is administered by intravenous infusion to the human subject.
2. The method of claim 1 , wherein the average number of MMAE molecules per cAC10 antibody of the cAC10-MC-vc-PAB-MMAE antibody-drug conjugate in the pharmaceutical composition is about 4.
3. The method of claim 1 , wherein the CD30-expressing hematologic cancer is Hodgkin Lymphoma.
4. The method of claim 3 , wherein the average number of MMAE molecules per cAC10 antibody of the cAC10-MC-vc-PAB-MMAE antibody-drug conjugate in the pharmaceutical composition is about 4.
5. The method of claim 1 , wherein the CD30-expressing hematologic cancer is anaplastic large cell lymphoma.
6. The method of claim 5 , wherein the average number of MMAE molecules per cAC10 antibody of the cAC10-MC-vc-PAB-MMAE antibody-drug conjugate in the pharmaceutical composition is about 4.
7. The method of claim 1 , wherein the human subject has not previously been treated for the CD30-expressing hematologic cancer.
8. The method of claim 3 , wherein the human subject has not previously been treated for the CD30-expressing hematologic cancer.
9. The method of claim 1 , wherein the human subject has been previously treated with one or more anti-cancer therapies and relapsed after the treatment.
10. The method of claim 9 , wherein the one or more anti-cancer therapies was a first-line chemotherapy regimen and/or a salvage regimen and/or an experimental treatment for the CD30-expressing hematologic cancer.
11. The method of claim 3 , wherein the human subject has been previously treated with one or more anti-cancer therapies and relapsed after the treatment.
12. The method of claim 5 , wherein the human subject has been previously treated with one or more anti-cancer therapies and relapsed after the treatment.
13. The method of claim 1 , wherein the human subject has been previously treated with one or more anti-cancer therapies and has experienced disease progression during treatment.
14. The method of claim 13 , wherein the one or more anti-cancer therapies was a first-line chemotherapy regimen and/or a salvage regimen and/or an experimental treatment for the CD30-expressing hematologic cancer.
15. The method of claim 3 , wherein the human subject has been previously treated with one or more anti-cancer therapies and has experienced disease progression during treatment.
16. The method of claim 5 , wherein the human subject has been previously treated with one or more anti-cancer therapies and has experienced disease progression during treatment.
17. The method of claim 1 , wherein the subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
18. The method of claim 17 , wherein the human subject has no detectable sign of the CD30-expressing hematologic cancer.
19. The method of claim 17 , wherein the human subject relapsed after the stem cell transplant.
20. The method of claim 3 , wherein the human subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
21. The method of claim 5 , wherein the human subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
22. The method of claim 1 , wherein the cAC10-MC-vc-PAB-MMAE antibody-drug conjugate has undergone lyophilization.
23. The method of claim 1 , further comprising administering an anti-inflammatory agent to the human subject.