JPWO2021214772A5

JPWO2021214772A5 -

Info

Publication number: JPWO2021214772A5
Application number: JP2022564317A
Authority: JP
Publication date: 2024-04-30

Claims

1. A composition for use in treating a hematological cancer in a subject in need thereof, comprising:
The composition comprises (2S)-2-amino-4-[[1-[(2R,3S,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-2-oxopyrimidin-4-yl]amino]-4-oxobutanoic acid (aspacitarabine) or a pharma- ceutically acceptable salt thereof;
The treatment of the hematological cancer comprises at least one initial course of therapy and at least one subsequent course of therapy, wherein the at least one initial course of therapy is administered until the subject goes into remission and the at least one subsequent course of therapy is administered while the subject is in remission, and wherein the at least one initial course of therapy , the at least one subsequent course of therapy, or both courses of therapy comprise administering the composition to the subject .

10. The composition of claim 1, wherein the at least one initial course of therapy comprises administering at least one anti-hematological cancer agent , or at least two anti-hematological cancer agents .

3. The composition of claim 1 or 2, wherein the at least one initial course of therapy comprises administering aspacitarabine or at least one anti-hematological cancer drug that is not aspacitarabine.

The composition of any one of claims 1 to 3 , wherein the at least one subsequent course of therapy comprises administering aspacitarabine or at least one anti-hematological cancer agent that is not aspacitarabine .

5. The composition of claim 1, wherein the at least one subsequent course of therapy comprises administering at least two anti-hematological cancer agents, one of the anti-hematological cancer agents being aspacitarabine, one of the anti-hematological cancer agents being not aspacitarabine, or a combination thereof .

2. The composition of claim 1, wherein the at least one initial course of therapy comprises administering aspacitarabine and at least one additional anti-hematological cancer agent, and the at least one subsequent course of therapy comprises administering aspacitarabine and at least one additional anti-hematological cancer agent, and the at least one additional anti-hematological cancer agent in the initial therapy and the subsequent therapy are the same or different.

2. The composition of claim 1, wherein the at least one initial course of therapy comprises administering aspacitarabine and at least one additional anti-hematological cancer agent, and the at least one subsequent course of therapy comprises aspacitarabine.

2. The composition of claim 1, wherein the at least one initial therapy comprises administering at least one anti-hematological cancer agent other than aspacitarabine, and the at least one subsequent course of therapy comprises aspacitarabine and optionally at least one additional anti-hematological cancer agent .

said at least one initial therapy comprises several courses until remission, each course being the same or different;
The composition according to any one of claims 1 to 8 , wherein said at least one subsequent therapy comprises several courses, each course being the same or different .

2. The composition of claim 1, wherein the hematological cancer is selected from leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN), and any combination thereof.

11. The composition of claim 10, wherein the leukemia is selected from acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphoblastic leukemia (CLL), and any combination thereof, and the lymphoma is selected from Hodgkin's lymphoma, non-Hodgkin's lymphoma (NHL), and any combination thereof .

12. The composition of any one of claims 2 to 11, wherein the at least one anti-hematological cancer agent is selected from a BCL2 inhibitor, a hypomethylating agent (HMA), antimetabolite, a targeted therapy, an immunotherapy, CAR-T, venetoclax, cytarabine, aspacitarabine, daunorubicin, idarubicin, cyclophosphamide, dexamethasone, daunorubicin hydrochloride and cytarabine liposomal, azacitidine, decitabine, glasdegib, sorafenib, midostaurin, ivosidenib, enasidenib, gemtuzumab, ozogamicin, gilteritinib, magrolimab, cusatuzumab, a CD47 inhibitor, APR-246, CART-123 , and any combination thereof.

The composition of any one of claims 2 to 11, wherein the at least one anti- hematological cancer agent is at least one of venetoclax and a hypomethylating agent (HMA), at least one of venetoclax and cytarabine, or at least one of venetoclax and aspacitarabine .

The composition of any one of claims 1 to 13 , wherein aspacitarabine is administered in a dose of 0.3 g/m ² /day to 10 g/m ² /day.

15. The composition of any one of claims 1 to 14, wherein the treatment of hematological cancer improves at least one clinical condition of the subject selected from DOR (duration of response), survival including overall survival (OS), event free survival (EFS), minimal residual disease (MRD), resulting in improved response, improved QoL , reduced frequency or severity of adverse events, hematological improvement, and any combination thereof.