Claims for Patent: 10,980,795

Summary for Patent: 10,980,795

Title:	Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Abstract:	Provided are methods for treating pancreatic cancer in a patient by administering liposomal irinotecan (MM-398) alone or in combination with additional therapeutic agents. In one embodiment, the liposomal irinotecan (MM-398) is co-administered with 5-fluorouracil and leucovorin.
Inventor(s):	Eliel Bayever, Navreet Dhindsa, Jonathan Basil FITZGERALD, Peter Laivins, Victor Moyo, Clet Niyikiza, Jaeyeon Kim
Assignee:	Ipsen Biopharm Ltd
Application Number:	US16/012,351
Patent Claims:	1. A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has previously been treated with gemcitabine, comprising intravenously administering an antineoplastic therapy to the patient once every two weeks, the therapy consisting of i) irinotecan sucrose octasulfate salt liposome injection in a dose providing the equivalent of 70 mg/m2 of irinotecan free base, ii) 200 mg/m2 of the (l) form of leucovorin or 400 mg/m2 of the (l+d) racemic form of leucovorin, and iii) 2400 mg/m2 of 5-fluorouracil. 2. The method of claim 1, wherein the metastatic adenocarcinoma of the pancreas has progressed after treatment with gemcitabine. 3. The method of claim 1, wherein the irinotecan sucrose octasulfate salt liposome injection comprises irinotecan sucrose octasulfate salt, phosphatidylcholine, cholesterol, and a polyethyleneglycol-derivatized phosphatidyl-ethanolamine. 4. The method of claim 3, wherein the polyethylene glycol in the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is N-(methoxy-poly(ethyleneglycol) (M.W. 2000)-oxycarbonyl)-distearoylphosphatidylethanolamine. 5. The method of claim 4, wherein the polyethyleneglycol-derivatized phosphatidyl-ethanolamine is in the amount of approximately one polyethyleneglycol derivatized phosphatidyl-ethanolamine molecule for 200 phosphatidylcholine molecules. 6. The method of claim 4, wherein the irinotecan sucrose octasulfate salt liposome injection comprises phosphatidylcholine, cholesterol, and N-(methoxy-poly(ethyleneglycol) (M.W. 2000)-oxycarbonyl)-distearoylphosphatidylethanolamine in a molar ratio of 3:2:0.015. 7. The method of claim 6, further comprising premedicating the human patient with an anti-emetic prior to administering the antineoplastic therapy. 8. The method of claim 6, wherein the irinotecan sucrose octasulfate salt liposome injection is administered followed by the leucovorin, followed by the 5-fluorouracil. 9. The method of claim 8, further comprising premedicating the human patient with an anti-emetic prior to administering the antineoplastic therapy. 10. The method of claim 8, wherein the irinotecan sucrose octasulfate salt liposome injection, leucovorin, and 5-fluorouracil are administered sequentially to the patient beginning on day 1 of a 2-week cycle. 11. The method of claim 10, further comprising premedicating the human patient with an anti-emetic prior to administering the antineoplastic therapy. 12. The method of claim 8, wherein the irinotecan sucrose octasulfate salt liposome injection is administered intravenously over 90 minutes, followed by intravenous administration of leucovorin over 30 minutes, followed by intravenous administration of 5-fluorouracil over 46 hours. 13. The method of claim 12, further comprising premedicating the human patient with an anti-emetic prior to administering the antineoplastic therapy. 14. The method of claim 1, wherein the leucovorin is provided by administering 400 mg/m2 of the (l+d) form of leucovorin. 15. The method of claim 14, further comprising premedicating the human patient with an anti-emetic prior to administering the antineoplastic therapy.