Granted Patent
B2
US 12,735,501 · App. 19/449,233 · Granted Sep 15, 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 (31)
1 . A method of treating multiple myeloma in a subject, comprising subcutaneously administering to the subject a pharmaceutical composition comprising daratumumab at a concentration of about 120 mg/mL, wherein the pharmaceutical composition:
a) has a hyaluronidase enzymatic activity of about 2000 U/mL,
b) has a total volume of about 15 mL, and
c) is administered to the subject at an infusion rate of about 4 mL/minute.
2 . The method of claim 1 , 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.
3 . The method of claim 2 , wherein the pharmaceutical composition is administered in the subsequent cycles until disease progression.
4 . The method of claim 2 , wherein the subject achieves a very good partial response following administering the pharmaceutical composition.
5 . The method of claim 2 , wherein the subject achieves a partial response following administering the pharmaceutical composition.
6 . The method of claim 2 , wherein the subject has had at least two prior lines of therapy including a proteasome inhibitor and an immunomodulatory drug.
7 . The method of claim 6 , wherein the subject is refractory to the proteasome inhibitor, the immunomodulatory drug, or both.
8 . The method of claim 2 , further comprising administering to the subject a corticosteroid selected from the group consisting of dexamethasone and prednisone.
9 . The method of claim 8 , wherein the corticosteroid is dexamethasone.
10 . The method of claim 9 , further comprising administering to the subject a proteasome inhibitor selected from the group consisting of bortezomib, carfilzomib, and ixazomib.
11 . The method of claim 10 , wherein the proteasome inhibitor is bortezomib.
12 . The method of claim 10 , wherein the proteasome inhibitor is carfilzomib.
13 . The method of claim 10 , wherein the proteasome inhibitor is ixazomib.
14 . The method of claim 9 , further comprising administering to the subject a glutamic acid derivative selected from the group consisting of lenalidomide, thalidomide, and pomalidomide.
15 . The method of claim 14 , wherein the glutamic acid derivative is lenalidomide.
16 . The method of claim 14 , wherein the glutamic acid derivative is thalidomide.
17 . The method of claim 14 , wherein the glutamic acid derivative is pomalidomide.
18 . The method of claim 9 , further comprising administering to the subject 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.
19 . The method of claim 8 , wherein the corticosteroid is prednisone.
20 . The method of claim 19 , further comprising administering to the subject a proteasome inhibitor selected from the group consisting of bortezomib, carfilzomib, and ixazomib.
21 . The method of claim 20 , wherein the proteasome inhibitor is bortezomib.
22 . The method of claim 20 , wherein the proteasome inhibitor is carfilzomib.
23 . The method of claim 20 , wherein the proteasome inhibitor is ixazomib.
24 . The method of claim 19 , further comprising administering to the subject a glutamic acid derivative selected from the group consisting of lenalidomide, thalidomide, and pomalidomide.
25 . The method of claim 19 , further comprising administering to the subject 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.
26 . The method of claim 25 , wherein the alkylating agent is melphalan.
27 . The method of claim 2 , wherein the administration produces a maximum daratumumab serum trough concentration (Ctrough) at Cycle 3 Day 1 that is higher than the maximum daratumumab serum Ctrough produced by a 16 mg/kg intravenous dose of daratumumab.
28 . The method of claim 2 , wherein the administration produces a lower rate of infusion related reactions than produced by a 16 mg/kg intravenous dose of daratumumab.
Continuity (7)
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