Treatment of Breast Cancer with Liposomal Irinotecan

Patent metadata

Field	Value
Publication number	US-2020360367-A1
Application number	US-201916711072-A
Country	US
Kind code	A1
Filing date	Dec 11, 2019
Priority date	Dec 9, 2014
Publication date	Nov 19, 2020
Grant date	—

Abstract

Provided are methods for treating breast cancer in a patient by administering effective amounts of liposomal irinotecan sucrosofate (MM-398). The breast cancer may be triple negative breast cancer (TNBC), estrogen receptor/progesterone receptor (ER/PR) positive breast cancer, ER-positive breast cancer, or PR-positive breast cancer, or metastatic breast cancer.

First claim

1 .- 6 . (canceled)

7 . A method of treating a patient having metastatic breast cancer with active brain metastasis comprising intravenously administering an antineoplastic therapy to the patient once every two weeks, the antineoplastic therapy consisting of a 60 mg/m 2 dose of liposomal irinotecan based on the molecular weight of irinotecan hydrochloride trihydrate.

8 . The method of claim 7 , wherein the breast cancer is HER2 negative breast cancer.

9 . The method of claim 7 , wherein the breast cancer is triple negative breast cancer.

10 . The method of claim 7 , wherein the active brain metastasis is at least one new or progressive brain metastasis after prior radiation therapy.

11 . The method of claim 10 , wherein the at least one new or progressive brain metastasis is greater than or equal to 1 cm in longest diameter on gadolinium-enhanced magnetic resonance imaging.

12 . The method of claim 7 , wherein the patient has failed at least one prior platinum-based chemotherapy regimen.

13 . The method of claim 7 , wherein the patient has failed prior treatment with gemcitabine or has become resistant to gemcitabine.

14 . The method of claim 7 , wherein prior to each administration of the liposomal irinotecan, the patient is pre-medicated with dexamethasone, an anti-emetic, or both dexamethasone and an anti-emetic.

15 . The method of claim 14 , wherein the anti-emetic is a 5-HT3 antagonist.

16 . The method of claim 7 , wherein the liposomal irinotecan is administered intravenously over 90 minutes.

17 . The method of claim 7 , wherein prior to treatment with the liposomal irinotecan, the patient receives a ferumoxytol infusion followed by a magnetic resonance imaging scan.

18 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan sucrose octasulfate encapsulated in liposomes.

19 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan encapsulated in liposome vesicles in a gelated or precipitated state as a sucrose octasulfate salt.

20 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan encapsulated in liposome vesicles comprising 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), cholesterol, and a polyethyleneglycol-derivatized phosphatidyl-ethanolamine.

21 . The method of claim 20 , wherein the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidylethanolamine (MPEG-2000-DSPE).

22 . The method of claim 20 , wherein the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is in the amount of approximately one polyethyleneglycol (PEG) molecule for every 200 phospholipid molecules.

23 . The method of claim 7 , wherein the liposomal irinotecan comprises irinotecan sucrose octasulfate encapsulated in liposomes having a unilamellar lipid bilayer vesicle comprising 6.81 mg/mL 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 2.22 mg/ml cholesterol, and 0.12 mg/ml methoxy-terminated polyethylene glycol (MW 2000)-distearoylphosphatidyl ethanolamine (MPEG-2000-DSPE).

Assignees

• Ipsen Biopharm Ltd

Inventors

• Bayever Eliel
• Fitzgerald Jonathan Basil
• Kim Jaeyeon
• Klinz Stephan

Classifications

• A61K9/1272

  comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers (lipids as modifying agents {A61K47/543}) · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61K31/4745 Primary

  condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48) · CPC title

• A61K9/1271

  Non-conventional liposomes, e.g. PEGylated liposomes or liposomes coated or grafted with polymers (liposomes as conjugates {A61K47/6911}) · CPC title

• A61P35/00

  Antineoplastic agents · CPC title