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Claims for Patent: 9,339,497

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Claims for Patent: 9,339,497

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): Bayever; Eliel (New York, NY), Dhindsa; Navreet (Boston, MA), Fitzgerald; Jonathan Basil (Cambridge, MA), Laivins; Peter (Rowayton, CT), Moyo; Victor (Concord, MA), Niyikiza; Clet (Gulph Mills, PA), Kim; Jaeyeon (Lexington, MA)
Assignee: Merrimack Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:14/812,950
Patent Claims: 1. A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has previously been treated with the antineoplastic agent gemcitabine, the method comprising intravenously administering to the patient once every two weeks 80 mg/m.sup.2 of the antineoplastic agent MM-398 liposomal irinotecan in combination with 200 mg/m.sup.2 of (l)-form of leucovorin or 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin and 2,400 mg/m.sup.2 of the antineoplastic agent 5-fluorouracil to treat the metastatic adenocarcinoma of the pancreas in the human patient, where no other antineoplastic agent is administered to the human patient for treatment of the metastatic adenocarcinoma of the pancreas.

2. The method of claim 1, wherein the leucovorin is administered as 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin.

3. The method of claim 1, wherein the MM-398 liposomal irinotecan, leucovorin and 5-fluorouracil are administered to the patient over 48 hours.

4. The method of claim 3, wherein 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin is administered to the patient prior to the 5-fluorouracil.

5. The method of claim 4, wherein the MM-398 liposomal irinotecan is administered to the patient prior to the leucovorin.

6. The method of claim 5, further comprising pre-medicating the patient with dexamethasone and a 5-HT3 antagonist or other anti-emetic prior to administering the MM-398 liposomal irinotecan.

7. The method of claim 1, wherein the patient has metastatic pancreatic cancer that has progressed on gemcitabine-based therapy prior to the administration of the MM-398 liposomal irinotecan.

8. The method of claim 1, wherein the MM-398 liposomal irinotecan is administered to the patient over 90 minutes.

9. The method of claim 8, wherein the leucovorin is administered over 30 minutes and the 5-FU is administered over 46 hours.

10. The method of claim 9, wherein the MM-398 liposomal irinotecan is administered over 90 minutes, followed by administration of the leucovorin over 30 minutes, followed by the administration of the 5-fluorouracil over 46 hours.

11. The method of claim 10, wherein the MM-398 liposomal irinotecan, leucovorin and 5-fluorouracil are administered to the patient beginning on day 1 of a 2-week cycle wherein the method comprises multiple cycles, and the leucovorin is administered as 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin.

12. A method of treating metastatic adenocarcinoma of the pancreas in a human patient who has previously been treated with the antineoplastic agent gemcitabine, the method comprising, intravenously administering to the patient once in a 2-week cycle, beginning on day 1 of the 2-week cycle, 80 mg/m.sup.2 of the antineoplastic agent MM-398 liposomal irinotecan over 90 minutes, followed by 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin or 200 mg/m.sup.2 of (l)-form of leucovorin, followed by 2,400 mg/m.sup.2 of the antineoplastic agent 5-fluorouracil, where the method comprises multiple cycles and no other antineoplastic agent is administered during each 2-week cycle to treat the metastatic adenocarcinoma of the pancreas in the human patient.

13. The method of 12, wherein the leucovorin is administered over 30 minutes and the 5-fluorouracil is administered over 46 hours.

14. The method of claim 12, wherein the patient has metastatic pancreatic cancer that has progressed on gemcitabine-based therapy prior to the administration of the MM-398.

15. A method of treating metastatic pancreatic cancer that has progressed on gemcitabine-based therapy, the method comprising administering an antineoplastic therapy over 48 hours once every two weeks to a patient in need thereof, to treat the metastatic pancreatic cancer in the patient, the antineoplastic therapy comprising a single intravenous administration of 80 mg/mm.sup.2 of MM-398 liposomal irinotecan, a single intravenous administration 200 mg/m.sup.2 of (l)-form of leucovorin or 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin, and a single intravenous administration of 2,400 mg/m.sup.2 of 5-fluorouracil, where the antineoplastic therapy does not include administration of another antineoplastic agent to the patient.

16. The method of claim 15, wherein the leucovorin is administered as 400 mg/m2 of the (l+d) racemic form of leucovorin.

17. The method of claim 15, wherein the MM-398 liposomal irinotecan is administered prior to the 5-fluorouracil.

18. The method of claim 17, wherein the administration of the MM-398 liposomal irinotecan is followed by the administration of the leucovorin.

19. The method of claim 18, wherein the administration of the leucovorin is followed by the administration of the 5-fluorouracil.

20. The method of claim 19, wherein the leucovorin is administered as 400 mg/m2 of the (l+d) racemic form of leucovorin.

21. The method of claim 15, wherein the antineoplastic therapy consists of the administration of the MM-398 liposomal irinotecan, the leucovorin and the 5-fluorouracil.

22. The method of claim 21, wherein the leucovorin is administered as 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin.

23. The method of claim 15, wherein the antineoplastic therapy consists of the administration of the MM-398 liposomal irinotecan, followed by administration of the leucovorin, followed by administration of the 5-fluorouracil.

24. The method of claim 23, wherein the leucovorin is administered as 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin.

25. The method of claim 15, further comprising pre-medicating the patient with dexamethasone and a 5-HT3 antagonist or other anti-emetic prior to administering the MM-398 liposomal irinotecan.

26. A method of treating metastatic pancreatic cancer that has progressed on gemcitabine-based therapy prior to the administration of a MM-398 liposomal irinotecan, the method comprising administering an antineoplastic therapy once every two weeks to a patient in need thereof to treat the metastatic pancreatic cancer in the patient, the antineoplastic therapy consisting of a single intravenous administration of 80 mg/mm.sup.2 of MM-398 liposomal irinotecan over 90 minutes, followed by a single intravenous administration of 200 mg/m.sup.2 of (l)-form of leucovorin or 400 mg/m.sup.2 of the (l+d) racemic form of leucovorin over 30 minutes, followed by a single intravenous administration of 2,400 mg/m.sup.2 of 5-fluorouracil over 46 hours.

27. The method of claim 26, further comprising pre-medicating the patient with an anti-emetic medication prior to administering the antineoplastic therapy.
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