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Melflufen dosage regimens for cancer

一种剂量、质量的技术，应用在医药配方、非有效成分的医用配制品、含有效成分的医用配制品等方向，能够解决致命、MM无法治愈等问题

Inactive Publication Date: 2018-07-17
ONCOPEPTIDES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Recent improvements in treatment have significantly prolonged survival, but despite these dramatic improvements, MM remains incurable and both are fatal

Method used

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  • Melflufen dosage regimens for cancer
  • Melflufen dosage regimens for cancer
  • Melflufen dosage regimens for cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0039] Example 2 and the aforementioned clinical study reporting PFS included most patients with refractory MM; the results of Example 2 compared favorably with the other studies mentioned above. At the data cutoff point for Example 2b, 29 of the 30 patients in Example 2a had refractory status. Of these 29 patients, 24 (83%) were IMiD refractory, 19 (66%) were PI refractory, and 15 (52%) were alkylating agent refractory. Seventeen (59%) of 29 patients were dual refractory (IMiD and PI), and 9 (31%) were dual and alkylating agent refractory. Twenty-three of 29 patients (79%) were refractory to the most recent line of treatment. The median number of prior treatments for all 40 patients was 4 (range 1 to 13). Available data show a rapid and durable treatment response to the combination of Metraphan with 40 mg weekly dexamethasone. Of the 30 patients evaluated, 19 (63%) reported a best response or better with MR and 12 (40%) reported PR or better.

[0040] As described in Exam...

Embodiment 1

[0206] Example 1: Evaluation of four dose levels (15, 25, 40 and 55 mg) of intravenous metropene hydrochloride (excluding The quality of the salt component) (in combination with dexamethasone treatment on days 1, 8 and 15) for a minimum of 1 cycle and a maximum of 12 cycles.

[0207] Example 2: Open-label single-arm extension at a dose of 40 mg within 30 minutes of Example 1. Administer intravenous metropene (with 40 mg dexamethasone (oral or intravenous) on Days 1, 8, and 15) over 30 minutes on Day 1 of a 21-day cycle or a 28-day cycle for At least 2 cycles, up to the specified number of cycles. During the clinical trial of Example 2, the cycle was extended from 21 days to 28 days according to the protocol modification, in order to better recover neutrophils and thrombus cells before the start of the new cycle.

[0208] The dose reduction from 40 mg to 25 mg metropene in patients in the trial may be related to the adverse effects of thrombocytopenia / neutropenia.

[0209] E...

Embodiment 2a

[0238] Example 2a is the data / results of Clinical Trial Example 2 at time point (a) during the clinical trial.

[0239] 3.1 Efficacy data from studies in patients with RRMM

[0240] Before the data cut-off point of Example 2a, 38 patients with recurrent MM had been given 40 mg of metropene hydrochloride (40 mg dose excluding the mass of the salt component) every 3 weeks (21 days) within 30 minutes with weekly administration of dexamethasone (days 1, 8 and 15). A total of 162 doses of metropene were administered. The median number of cycles started was 3 (1-13), and the median treatment duration was 13 weeks (2-51). The mean dose intensity was 96% (77-100). According to the data cutoff point, 10 patients remained on treatment, 2 completed treatment, and 26 patients discontinued treatment (15 due to AEs, 8 due to PD, 2 deaths, 1 due to other reasons). Twenty-seven patients remained on study (10 patients on treatment, 17 on follow-up), while 11 patients were not on study (8 p...

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Abstract

The present invention providesmelflufen (melphalan flufenamide; L-Melphalanyl-4-fluoro-L-phenylalanine ethyl ester), or a salt thereof, for use in the treatment or prophylaxis of multiple myeloma, wherein a dosage of melflufen (excluding the mass of any salt) is administered as a parenteral dosage at an infusion rate of 1.0 to 1.8 mg / min. Also provided is melflufen, or a salt thereof, for use in the treatment or prophylaxis of a cancer, for example a solid cancer, wherein a dosage of melflufen is administered as a parenteral dosage at an infusion rate less than 0.8 mg / min (for example 0.3 to 1.0 mg / minor for example 0.3 to 0.8 mg / min).

Description

field of invention [0001] The present invention relates to melflufen (melflufen; L-melphalanyl-4-fluoro-L-phenylalanine ethyl ester) or its Particularly preferred dosage regimens for salts. Background of the invention [0002] Multiple myeloma (MM) is a malignant cancer of differentiated plasma cells. It is characterized by clonal proliferation of plasma cells and the production of excess monoclonal immunoglobulins (often IgG or IgA type or free urinary light chains [paraprotein, M protein, or M component]) in the bone marrow. [0003] MM affects older patients, with a median age of onset of 65 to 70 years and a slight male predominance. MM is the second most common hematological malignancy, with nearly 24,000 myeloma patients diagnosed in the United States each year. Patients with MM may experience severe impairment of quality of life, including bone pain, fractures, fatigue, anemia, infection, hypercalcemia, high viscosity, and renal impairment (including renal failure)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/223A61K31/573
CPCA61K31/223A61K31/573A61P35/00A61K31/216A61K2300/00A61K9/08A61K47/26A61K9/0019A61K9/00A61K38/05
Inventor J·林德伯格
Owner ONCOPEPTIDES
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