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 subject in need thereof a dose of a pharmaceutical composition comprising cAC10-MC-vc-PAB-MMAE antibody-drug conjugate, wherein the administered dose of cAC10-MC-vc-PAB-MMAE antibody-drug conjugate is 1.8 mg/kg of the subject's body weight and the pharmaceutical composition is administered every three weeks as a monotherapy, wherein the pharmaceutical composition is administered for two or more 21-day treatment cycles.
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 pharmaceutical composition is administered for 3 or more treatment cycles.
8. The method of claim 1 , wherein the pharmaceutical composition is administered for 5 or more treatment cycles.
9. The method of claim 1 , wherein the pharmaceutical composition is administered for 10 or more treatment cycles.
10. The method of claim 1 , wherein the pharmaceutical composition is administered on day 1 of the 21 day treatment cycle.
11. The method of claim 1 , wherein the subject has not previously been treated for the CD30-expressing hematologic cancer.
12. The method of claim 1 , wherein the subject has been previously treated with one or more anti-cancer therapies and relapsed after the treatment.
13. The method of claim 12 , 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.
14. The method of claim 3 , wherein the subject has been previously treated with one or more anti-cancer therapies and relapsed after the treatment.
15. The method of claim 5 , wherein the subject has been previously treated with one or more anti-cancer therapies and relapsed after the treatment.
16. The method of claim 1 , wherein the subject has been previously treated with one or more anti-cancer therapies and has experienced disease progression during treatment.
17. The method of claim 16 , 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.
18. The method of claim 3 , wherein the subject has been previously treated with one or more anti-cancer therapies and has experienced disease progression during treatment.
19. The method of claim 5 , wherein the subject has been previously treated with one or more anti-cancer therapies and has experienced disease progression during treatment.
20. The method of claim 1 , wherein the subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
21. The method of claim 20 , wherein the subject has no detectable sign of the CD30-expressing hematologic cancer.
22. The method of claim 20 , wherein the subject relapsed after the stem cell transplant.
23. The method of claim 3 , wherein the subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
24. The method of claim 5 , wherein the subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
25. The method of claim 1 , wherein the pharmaceutical composition is administered by injection to the subject.
26. The method of claim 1 , wherein the pharmaceutical composition is administered by intravenous infusion to the subject.
27. The method of claim 3 , wherein the pharmaceutical composition is administered by intravenous infusion to the subject.
28. The method of claim 5 , wherein the pharmaceutical composition is administered by intravenous infusion to the subject.
29. The method of claim 1 , wherein the cAC10-MC-vc-PAB-MMAE antibody-drug conjugate has undergone lyophilization.
30. The method of claim 1 , further comprising administering an anti-inflammatory agent to the subject.