Methods for the treatment of leptomeningeal carcinomatosis
Inventors
Castaigne, Jean-Paul • Lawrence, Betty • KUMTHEKAR, Priya
Assignees
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Publication Number
US-10980892-B2
Publication Date
2021-04-20
Expiration Date
Abstract
The present invention features a method of treating leptomeningeal carcinomatosis in a subject using a peptide-therapeutic conjugate as exemplified by the agent ANG1005.
Core Innovation
The invention relates to a method for the treatment of leptomeningeal carcinomatosis (LC). The method administers a compound having a structure as recited, to a subject in need thereof, as an effective amount. The compound is exemplified by peptide-therapeutic conjugates including ANG1005.
The document provides a rationale for cerebrospinal fluid (CSF) and membrane delivery based on interaction of a peptide component with LRP receptors on the blood-CSF barrier. The peptide-therapeutic conjugate includes an Angiopep-2 moiety linked to taxane payloads, such as paclitaxel and/or docetaxel.
The document reports clinical support for treatment in LC, including RECIST response rates and case responses in LC patients previously treated with standard therapies, along with Kaplan-Meier survival estimates. The document also describes additional combination, add-on anticancer and palliative therapies and defines endpoints including symptom burden, lesion burden, and CSF cell burden, while administration emphasizes intravenous dosing.
Claims Coverage
The independent claim covers a method for treating leptomeningeal carcinomatosis using a structured compound administered intravenously, with dependent claims refining the clinical context, additional anticancer therapy, tumor subtype/tumor origin, and palliative therapy components. At least one independent claim is identified, and the inventive features are centered on the compound structure with intravenous administration, plus optional refinements specified in the dependents.
Treating leptomeningeal carcinomatosis with a structured intravenous compound
A method for the treatment of leptomeningeal carcinomatosis comprising administering to a subject in need thereof an effective amount of a compound having the structure as recited, wherein the compound is administered intravenously.
Adding additional anticancer therapy to the intravenous compound regimen
The method further comprises administering an additional anticancer therapy.
Additional anticancer therapy includes radiation therapy and/or a chemotherapeutic agent
The additional anticancer therapy comprises radiation therapy and/or a chemotherapeutic agent.
Prior-therapy failure or relapse context
The solid tumor and/or leptomeningeal carcinomatosis failed to respond to previously received anticancer therapy and/or relapsed after that treatment.
HER2-positive breast tumor patient selection
The method is performed when the breast tumor has been identified as a HER2-positive tumor.
Palliative therapy selection including listed agent classes
The palliative therapy includes at least one of an analgesic, an anticonvulsant, an antidepressant, an anxiolytic, a psychostimulant, modafinil, palliative radiation, corticosteroids, an H1 antagonist, a hematopoietic growth factor, and/or a blood transfusion.
Overall, the claim set is anchored by treating leptomeningeal carcinomatosis with an effective amount of a structured compound administered intravenously. Dependent claims then specify optional combination with additional anticancer therapy (radiation and/or a chemotherapeutic agent), define a prior-therapy failure/relapse clinical context, narrow to subpopulations such as HER2-positive breast tumor, and expand palliative therapy options by listing particular palliative agent and modality categories.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treatment of leptomeningeal carcinomatosis (LC) in subjects requiring such treatment, including intravenous administration of peptide-therapeutic conjugates exemplified by ANG1005.
Use in LC patients previously treated with standard therapies, with reported RECIST responses and Kaplan-Meier survival estimates [documented clinical support as described].
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