Combination of local and systemic immunomodulative therapies for melanoma and liver cancer
Inventors
Eagle, Craig J. • Dees, H. Craig • Wachter, Eric A. • Singer, Jamie
Assignees
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Publication Number
US-9808524-B2
Publication Date
2017-11-07
Expiration Date
Abstract
A method for the treatment of cancer comprising administration of a therapeutically effective amount of an intralesional chemoablative pharmaceutical composition, or variant of said composition, in combination with a therapeutically effective amount of a systemic immunomodulatory anticancer agent. A further method for the treatment of cancer comprising administration of a therapeutically effective amount of an intralesional chemoablative pharmaceutical composition, or variant of said composition, in combination with a therapeutically effective amount of a systemic targeted anticancer agent. The present invention is further directed to pharmaceutical compositions for treatment of cancer. The intralesional chemoablative pharmaceutical composition can comprise an IL chemoablative agent comprising primarily a halogenated xanthene.
Core Innovation
The invention relates to a method of treatment of a melanoma, or a primary or metastatic liver cancer tumor in a human. The method separately administers a therapeutically effective amount of an intralesional chemoablative pharmaceutical composition to elicit ablation of at least one melanoma or primary or metastatic liver cancerous tumor and a therapeutically effective amount of a systemic immunomodulatory anticancer agent.
The systemic immunomodulatory anticancer agent comprises anti-CTLA-4 antibodies, anti-PD-L1 antibodies or anti-PD-1 antibodies. The intralesional chemoablative pharmaceutical composition includes an intralesional (IL) chemoablative agent.
In embodiments, the IL chemoablative agent comprises rose bengal in an appropriate pharmaceutical composition, including a 0.1% (w/v) or higher concentration aqueous solution of rose bengal, or a physiologically acceptable salt of rose bengal. In other embodiments, the IL chemoablative agent comprises a halogenated xanthene in an appropriate pharmaceutical composition.
Claims Coverage
The independent claims cover 4 inventive features directed to separate administration of an intralesional chemoablative composition and a systemic immunomodulatory anticancer agent for treatment of melanoma or primary/metastatic liver cancer, with features tied to immune checkpoint antibodies and the IL chemoablative agent formulation.
Separately administering an IL chemoablative composition plus systemic immunomodulatory antibodies
A method of treatment of a melanoma, or a primary or metastatic liver cancer tumor in a human comprising separately administering a therapeutically effective amount of an intralesional chemoablative pharmaceutical composition to elicit ablation of at least one melanoma, or primary or metastatic liver cancerous tumor, and a therapeutically effective amount of a systemic immunomodulatory anticancer agent comprising anti-CTLA-4 antibodies, anti-PD-L1 antibodies or anti-PD-1 antibodies.
Rose bengal IL chemoablative agent at specified concentration and lesion volume
The intralesional chemoablative pharmaceutical composition comprises an intralesional (IL) chemoablative agent comprising rose bengal in an appropriate pharmaceutical composition, including a 0.1% (w/v) or higher concentration aqueous solution of rose bengal, or a physiologically acceptable salt of rose bengal, wherein the intralesional chemoablative pharmaceutical composition is administered intralesionally into the at least one melanoma, or primary or metastatic liver cancerous tumor at about 0.1 mL/cc lesion volume to about 2 mL/cc lesion volume.
Halogenated xanthene IL chemoablative agent
The intralesional chemoablative pharmaceutical composition comprises an intralesional (IL) chemoablative agent comprising a halogenated xanthene in an appropriate pharmaceutical composition, including a 0.1% (w/v) or higher concentration aqueous solution of the halogenated xanthene or mixtures thereof, or a physiologically acceptable salt of the halogenated xanthene.
Systemic immunomodulatory agent as immune down-regulation inhibitor or immune up-regulation enhancer
A method wherein the systemic immunomodulatory anticancer agent is a systemic inhibitor of immune system down-regulation or a systemic enhancer of immune system up-regulation in a combination therapeutic regimen, comprising anti-CTLA-4 antibodies, anti-PD-L1 antibodies or anti-PD-1 antibodies.
Across the independent claims, the core claim coverage is directed to separate administration of an IL chemoablative composition and a systemic immunomodulatory anticancer agent with specified immune checkpoint antibody targets, together with rose bengal or halogenated xanthene IL chemoablative agents and IL administration into melanoma or primary/metastatic liver cancerous tumors.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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