Granted Patent
B2
US 12,742,018 · App. 19/449,144 · Granted Sep 22, 2026
Subcutaneous formulations of daratumumab and their uses in treating multiple myeloma
Assignee:
JANSSEN BIOTECH, INC.
C07K16/2896A61K9/0019A61K38/47A61K39/3955A61K45/06A61K47/02A61K47/12A61K47/20A61K47/22A61K47/26A61P35/00A61K2039/505A61K2039/54A61K2039/545A61K2039/55C07K2317/94
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Abstract
The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.
Claims (33)
1 . A method of treating multiple myeloma in a subject, comprising subcutaneously administering to the subject a pharmaceutical composition comprising:
a) daratumumab at a concentration of about 120 mg/mL, and
b) rHuPH20 recombinant hyaluronidase,
wherein the pharmaceutical composition has a total volume of about 15 mL and has a hyaluronidase enzymatic activity of about 2000 U/mL.
2 . The method of claim 1 , wherein the pharmaceutical composition has a pH of 5.0 to 6.0.
3 . The method of claim 2 , wherein the pharmaceutical composition comprises a buffer.
4 . The method of claim 3 , wherein the buffer comprises histidine at a concentration of about 5 mM to about 50 mM.
5 . The method of claim 4 , wherein the buffer comprises histidine at a concentration of about 8 mM.
6 . The method of claim 3 , wherein the pharmaceutical composition comprises a saccharide.
7 . The method of claim 6 , wherein the saccharide is sorbitol at a concentration of about 100 mM to about 300 mM.
8 . The method of claim 7 , wherein the saccharide is sorbitol at a concentration of about 270 mM.
9 . The method of claim 6 , wherein the pharmaceutical composition comprises a surfactant.
10 . The method of claim 9 , wherein the surfactant is polysorbate 20 at a concentration of about 0.01% w/v to about 0.1% w/v.
11 . The method of claim 10 , wherein the surfactant is polysorbate 20 at a concentration of about 0.04% w/v.
12 . The method of claim 9 , wherein the pharmaceutical composition comprises an antioxidant.
13 . The method of claim 12 , wherein the buffer comprises histidine at a concentration of about 5 mM to about 50 mM, the saccharide is sorbitol at a concentration of about 100 mM to about 300 mM, the surfactant is polysorbate 20 at a concentration of about 0.01% w/v to about 0.1% w/v, and the antioxidant is methionine at a concentration of about 0.1 mg/mL to about 2.5 mg/mL.
14 . The method of claim 13 , wherein the pharmaceutical composition is administered once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles, wherein each cycle is 28 days.
15 . The method of claim 14 , wherein the pharmaceutical composition has a pH of about 5.5.
16 . The method of claim 1 , further comprising administering to the subject a second therapeutic agent, wherein the second therapeutic agent comprises a proteasome inhibitor selected from the group consisting of bortezomib, carfilzomib, and ixazomib.
17 . The method of claim 16 , further comprising administering to the subject a corticosteroid selected from the group consisting of dexamethasone and prednisone.
18 . The method of claim 17 , wherein the corticosteroid is dexamethasone.
19 . The method of claim 18 , wherein the proteasome inhibitor is bortezomib.
20 . The method of claim 18 , wherein the proteasome inhibitor is carfilzomib.
21 . The method of claim 17 , wherein the corticosteroid is prednisone.
22 . The method of claim 21 , wherein the proteasome inhibitor is bortezomib.
23 . The method of claim 1 , further comprising administering to the subject a second therapeutic agent, wherein the second therapeutic agent comprises a glutamic acid derivative selected from the group consisting of lenalidomide, thalidomide, and pomalidomide.
24 . The method of claim 23 , further comprising administering to the subject a corticosteroid selected from the group consisting of dexamethasone and prednisone.
25 . The method of claim 24 , wherein the corticosteroid is dexamethasone.
26 . The method of claim 25 , wherein the glutamic acid derivative is lenalidomide.
27 . The method of claim 25 , wherein the glutamic acid derivative is thalidomide.
28 . The method of claim 25 , wherein the glutamic acid derivative is pomalidomide.
29 . The method of claim 1 , further comprising administering to the subject a second therapeutic agent, wherein the second therapeutic agent comprises an alkylating agent selected from the group consisting of busulfan, cyclophosphamide, bendamustine, chlorambucil, carboplatin, cisplatin, temozolomide, melphalan, carmustine, lomustine, dacarbazine, oxaliplatin, ifosfamide, mechlorethamine, thiotepa, trabectedin or streptozocin.
30 . The method of claim 29 , further comprising administering to the subject a corticosteroid selected from the group consisting of dexamethasone and prednisone.
Continuity (7)
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