COMBINATION TREATMENT FOR CANCER
Disclosed herein is a method of treating cancer, such as multiple myeloma, involving the combination of an anti-BCMA antigen binding protein (e.g., an anti-BCMA antibody) and an immunomodulatory drug (e.g. pomalidomide or lenalidomide). The combinations can also include an anti-inflammatory compound (e.g. dexamethasone).
1 . A method of treating cancer in a subject in need thereof comprising administering a therapeutically effective dose of a combination comprising an anti-BCMA antigen binding protein and an immunomodulatory imide drug (IMiD).
2 . The method of claim 1 , wherein the combination further comprises an anti-inflammatory compound.
3 . The method of claim 1 , wherein the wherein the anti-BCMA antigen binding protein comprises a CDRH1 comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:1; a CDRH2 comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:2; a CDRH3 comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:3; a CDRL1 comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:4; a CDRL2 comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:5; and a CDRL3 comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:6.
4 . The method of claim 1 , wherein the wherein the anti-BCMA antigen binding protein is an antibody comprising a heavy chain variable region (VH) comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:7; and a light chain variable region (VL) comprising an amino acid sequence with at least 90% sequence identity to the amino acid sequence set forth in SEQ ID NO:8.
5 . The method of claim 1 , wherein the anti-inflammatory compound is dexamethasone.
6 . The method of claim 1 , wherein the IMiD is a thalidomide analogue.
7 . The method of claim 1 , wherein the IMiD is pomalidomide.
8 . The method of claim 1 , wherein the IMiD is lenalidomide.
9 . The method of claim 1 , wherein the anti-BCMA antigen binding protein is an immunoconjugate comprising an antibody conjugated to a cytotoxin.
10 . The method of claim 9 , wherein the cytotoxin is selected from MMAE or MMAF.
11 . The method of claim 1 , wherein the cancer is selected from multiple myeloma, chronic lymphocytic leukemia, Waldenstroem's Macroglobulinemia, and non-Hodgkin's lymphoma.
12 . The method of claim 1 , wherein 1.9 mg/kg, 2.5 mg/kg, or 3.4 mg/kg of an anti-BCMA antigen binding protein is administered on day 1 of a 28-day cycle.
13 . The method of claim 1 , wherein the IMiD is pomalidomide and wherein 4 mg of pomalidomide is administered on days 1-21 of a 28-day cycle.
14 . The method of claim 1 , wherein the IMiD is lenalidomide and wherein 10 mg or 25 mg of lenalidomide is administered on days 1-21 of a 28-day cycle.
15 . The method of claim 1 , wherein the anti-inflammatory compound is dexamethasone and wherein and 20 mg or 40 mg of dexamethasone is administered on days 1-4, 9-12, and 17-20 of a 28-day cycle or on days 1, 8, 15, and 22 of a 28-day cycle.
16 . (canceled)
17 . (canceled)
18 . A kit for use in the treatment of cancer comprising:
(i) an anti-BCMA antigen binding protein;
(ii) instructions for use in the treatment of cancer when combined with an IMiD and, optionally, an anti-inflammatory compound.
19 . (canceled)
20 . (canceled)
21 . A method of treating relapsed/refractory multiple myeloma in a subject that has been treated with at least one prior cancer treatment comprising administering:
1.9 mg/kg, 2.5 mg/kg, or 3.4 mg/kg of an anti-BCMA antibody-drug conjugate on day 1 of a 28-day cycle; wherein the anti-BCMA antibody drug conjugate comprises an antibody comprising the heavy chain amino acid sequence set forth in SEQ ID NO:9 and the light chain amino acid sequence set forth in SEQ ID NO:10, and wherein the antibody is conjugated to MMAF;
10 mg or 20 mg of lenalidomide on days 1-21 of a 28-day cycle; and
20 mg or 40 mg of dexamethasone on days 1, 8, 15, and 22 of a 28-day cycle.
22 . A method of treating relapsed/refractory multiple myeloma in a subject that has been treated with at least two prior cancer treatments comprising administering:
1.9 mg/kg, 2.5 mg/kg, or 3.4 mg/kg of an anti-BCMA antibody-drug conjugate on day 1 of a 28-day cycle; wherein the anti-BCMA antibody drug conjugate comprises an antibody comprising the heavy chain amino acid sequence set forth in SEQ ID NO:9 and the light chain amino acid sequence set forth in SEQ ID NO:10, and wherein the antibody is conjugated to MMAF;
4 mg of pomalidomide on days 1-21 of a 28-day cycle; and
20 mg or 40 mg of dexamethasone on days 1, 8, 15, and 22 of a 28-day cycle.
23 . A method of treating primary amyloidosis (AL) in a subject in need thereof comprising administering a therapeutically effective dose of a combination comprising an anti-BCMA antigen binding protein and an immunomodulatory imide drug (IMiD).