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 for two or more 21-day treatment cycles, wherein the pharmaceutical composition is administered by intravenous infusion to the human subject.
2. The method of claim 1 , wherein the pharmaceutical composition is administered for 3 or more treatment cycles.
3. The method of claim 1 , wherein the pharmaceutical composition is administered for 5 or more treatment cycles.
4. The method of claim 1 , wherein the pharmaceutical composition is administered for 10 or more treatment cycles.
5. The method of claim 1 , wherein the pharmaceutical composition is administered on day 1 of the 21-day treatment cycle.
6. 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.
7. The method of claim 6 , wherein the pharmaceutical composition is administered for 3 or more treatment cycles.
8. The method of claim 6 , wherein the pharmaceutical composition is administered for 5 or more treatment cycles.
9. The method of claim 6 , wherein the pharmaceutical composition is administered for 10 or more treatment cycles.
10. The method of claim 6 , wherein the pharmaceutical composition is administered on day 1 of the 21-day treatment cycle.
11. The method of claim 1 , wherein the CD30-expressing hematologic cancer is Hodgkin Lymphoma.
12. The method of claim 11 , wherein the pharmaceutical composition is administered for 3 or more treatment cycles.
13. The method of claim 11 , wherein the pharmaceutical composition is administered for 5 or more treatment cycles.
14. The method of claim 11 , wherein the pharmaceutical composition is administered for 10 or more treatment cycles.
15. The method of claim 11 , wherein the pharmaceutical composition is administered on day 1 of the 21-day treatment cycle.
16. The method of claim 11 , 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.
17. The method of claim 1 , wherein the CD30-expressing hematologic cancer is anaplastic large cell lymphoma.
18. The method of claim 17 , wherein the pharmaceutical composition is administered for 3 or more treatment cycles.
19. The method of claim 17 , wherein the pharmaceutical composition is administered for 5 or more treatment cycles.
20. The method of claim 17 , wherein the pharmaceutical composition is administered for 10 or more treatment cycles.
21. The method of claim 17 , wherein the pharmaceutical composition is administered on day 1 of the 21-day treatment cycle.
22. The method of claim 17 , 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.
23. The method of claim 1 , wherein the human subject has not previously been treated for the CD30-expressing hematologic cancer.
24. The method of claim 11 , wherein the human subject has not previously been treated for the CD30-expressing hematologic cancer.
25. The method of claim 17 , wherein the human subject has not previously been treated for the CD30-expressing hematologic cancer.
26. 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.
27. 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.
28. The method of claim 1 , wherein the subject has previously undergone a stem cell transplant for treatment of the CD30-expressing hematologic cancer.
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.