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Treating gastric cancer using combination therapies comprising liposomal irinotecan, oxaliplatin, 5-fluoruracil (and leucovorin)

A technology of leucovorin and irinotecan, which is applied in the field of combination therapy including liposome irinotecan, oxaliplatin, 5-fluorouracil (and leucovorin) to treat gastric cancer, can solve Issues such as unknown impact on efficacy and safety

Pending Publication Date: 2019-11-01
IPSEN BIOPHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, due to toxicity, modified FOLFIRINOX regimens (e.g., elimination of 5-FU boluses) are often used, the effect of which on the efficacy and safety of the modified schedule is unknown

Method used

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  • Treating gastric cancer using combination therapies comprising liposomal irinotecan, oxaliplatin, 5-fluoruracil (and leucovorin)
  • Treating gastric cancer using combination therapies comprising liposomal irinotecan, oxaliplatin, 5-fluoruracil (and leucovorin)
  • Treating gastric cancer using combination therapies comprising liposomal irinotecan, oxaliplatin, 5-fluoruracil (and leucovorin)

Examples

Experimental program
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Effect test

Embodiment approach

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[0102] Liposomal irinotecan is preferably administered intravenously in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin. In one embodiment, liposomal irinotecan is administered before oxaliplatin, 5-FU and leucovorin. In another embodiment, the leucovorin is administered prior to the 5-FU. In another embodiment, MM-398 liposomal irinotecan is administered, followed by oxaliplatin, followed by leucovorin, and followed by 5-fluorouracil. In certain embodiments, liposomal irinotecan is administered intravenously to the patient over 90 minutes. In another embodiment, oxaliplatin is administered to the patient intravenously over 120 minutes. In another embodiment, 5-FU is administered intravenously over 46 hours. In one embodiment, oxaliplatin is administered about 6 to about 72 hours after admi...

Embodiment 1

[0117] Example 1: Evaluation of in vivo tolerance and efficacy of nal-IRI in a gastric tumor model

[0118] The antitumor activity of MM-398 was evaluated in MKN-45 and KATO III gastric tumor models. Xenograft tumor-bearing mice were treated with saline, 25 mg / kg free irinotecan, 5 mg / kg MM-398, 10 mg / kg MM-398, or 20 mg / kg MM-398 once a week for 4 weeks ( Figure 1A with Figure 1B ). All doses were well tolerated. nal-IRI exhibited antitumor activity with tumor regression at 10 and 20 mg / kg.

Embodiment 2

[0119] Example 2: Evaluation of in vivo tolerability and efficacy of combination therapy in animal models

[0120] The antitumor activity of MM-398 was evaluated in the context of triple agent combination therapy with 5-FU and oxaliplatin compared to free irinotecan. With saline, 100mg / kg 5-FU+5mg / kg oxaliplatin, 25mg / kg free irinotecan, 5mg / kg MM-398, free irinotecan+5-FU+oxaliplatin or MM-398+ Mice with xenograft tumors bearing MKN-45 were treated with a triple dose of 5-FU+oxaliplatin administered once a week for 3 weeks. All groups were performed in the same study and were split into two subgroups for visualization purposes. 5-FU was administered intraperitoneally, while all other agents were administered intravenously; days of administration are indicated by horizontal dashed lines; n=X( Figure 2A with Figure 2B ).

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Abstract

Combination therapy regimens including liposomal irinotecan, oxaliplatin and 5-fluorouracil are useful in the treatment of gastric cancer, including treatment of patients diagnosed with previously untreated gastric cancer. The combination therapy can include the administration of liposomal irinotecan, oxaliplatin, leucovorin and 5-fluorouracil once every two weeks.

Description

technical field [0001] The present disclosure relates to novel therapies available for the treatment of gastric cancer comprising the use of liposomal irinotecan in combination with 5-fluorouracil and oxaliplatin for (first-line) use in patients diagnosed with previously untreated gastric cancer treat. Background technique [0002] Gastric cancer is one of the most common causes of cancer-related mortality worldwide. In the United States, approximately 18,000 metastatic gastric cancer patients are expected to be treated with drug regimens in 2015. Of this population, approximately 7,000 patients fall into the HER2-negative first-line treatment category. HER2-negative gastric cancer is a highly heterogeneous disease, and targeted therapies such as bevacizumab, relotumumab, and cetuximab have been unsuccessful. Many gastric cancer patients present with advanced disease at diagnosis, complicating prognosis. There is currently no globally accepted standard chemotherapy regim...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P35/00A61K31/4453A61K31/4178A61K31/513A61K31/519A61K9/127
CPCA61K9/127A61K31/4178A61K31/4453A61K31/513A61K31/519A61P35/00A61K9/0019A61K2300/00A61K31/437A61K33/243A61K31/4745A61K31/555
Inventor B·张S·布劳恩J·B·菲茨杰拉德A·卡拉S·伦纳德
Owner IPSEN BIOPHARM LTD
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