Granted Patent B2

US 12,636,340 · App. 17/243,863 · Granted May 26, 2026

Inventor: Zandra Klippel (Newbury Park, CA)

Assignees: ONYX PHARMACEUTICALS, INC.; Janssen Biotech, Inc.

A61K38/07A61K31/573A61K39/3955A61P35/00A61K2039/505A61K2039/545

Abstract

Claims (25)

1 . A method of treating relapsed or refractory multiple myeloma in a subject suffering therefrom comprising administering to the subject a therapeutically effective amount of a triplet therapy of (a) carfilzomib; (b) daratumumab; and (c) dexamethasone,

wherein the subject had previously been treated with at least 1 line of treatment, and

the triplet therapy is administered in cycles of 4 weeks and carfilzomib is administered on day 1 and day 2 of a first cycle at a dose of 20 mg/m 2 , then at a twice weekly dose of 56 mg/m 2 for week 2 and week 3 with a one week dosing holiday, and at a twice weekly dose of 56 mg/m 2 for three weeks and a one week dosing holiday during subsequent cycles.

2 . The method of claim 1 , wherein the subject had previously been on a lenalidomide treatment, a bortezomib treatment, or both.

3 . The method of claim 1 , wherein the subject exhibits longer progression-free survival, compared to a subject on a doublet therapy of carfilzomib and dexamethasone alone.

4 . The method of claim 1 , wherein the subject administered the triplet therapy exhibits higher minimal residual disease (MRD) negative-complete response rate, compared to a subject on a doublet therapy of carfilzomib and dexamethasone alone.

5 . The method of claim 4 , wherein the subject administered the triplet therapy exhibits a MRD negative-complete response rate that is at least 5 times higher than that of a subject on the doublet therapy of carfilzomib and dexamethasone alone.

6 . The method of claim 1 , wherein a risk of progression or death is lower for a subject administered the triplet therapy, compared to a subject on a doublet therapy of carfilzomib and dexamethasone alone.

7 . The method of claim 1 , wherein carfilzomib is administered via infusion.

8 . The method of claim 1 , wherein daratumumab is administered according to a dosing regimen of:

(i) a dose of 8 mg/kg on day 1 and day 2 of week 1 of a first 4-week cycle,

(ii) a dose of 16 mg/kg once weekly for weeks 2, 3, and 4 of the first 4-week cycle,

(iii) a dose of 16 mg/kg once weekly for all doses of a second 4-week cycle,

(iv) a dose of 16 mg/kg once every two weeks for all doses for 4-week cycles 3, 4, 5, and 6, and

(v) a dose of 16 mg/kg once every four weeks for each 4-week cycle thereafter.

9 . The method of claim 1 , wherein the dexamethasone is administered orally.

10 . The method of claim 1 , wherein the dexamethasone is administered intravenously.

11 . The method of claim 1 , wherein the dexamethasone is administered at a dose of 20 mg or 40 mg weekly.

12 . The method of claim 11 , wherein the subject is 75 years old or older and is administered dexamethasone at a dose of 20 mg weekly.

13 . The method of claim 11 , wherein the dexamethasone dose is 40 mg weekly and is administered in successive days in two divided doses of 20 mg each.

14 . The method of claim 13 , wherein the dexamethasone is administered 30 minutes to 4 hours before the carfilzomib.

15 . The method of claim 14 , wherein the daratumumab is administered after the carfilzomib.

16 . The method of claim 7 , wherein carfilzomib is administered via infusion over 30 minutes.

17 . The method of claim 2 , wherein the subject is refractory to at least one of the lenalidomide treatment and bortezomib treatment.

18 . The method of claim 1 , wherein the subject is refractory to at least one of the lenalidomide treatment and bortezomib treatment, and the subject administered the triplet therapy exhibits higher minimal residual disease (MRD) negative-complete response rate, compared to a subject on a doublet therapy of carfilzomib and dexamethasone alone.

Assignments (2)

Continuity (2)

References Cited (59)