Method for treating checkpoint inhibitors induced adverse events

Inventors

SALEM, Joe-Elie • Allenbach, Yves • KERNEIS, Mathieu • MOSLEHI, Javid • Johnson, Douglas

Assignees

Assistance Publique Hopitaux de Paris APHP • Institut National de la Sante et de la Recherche Medicale INSERM • Sorbonne Universite • Vanderbilt University

Abstract

The invention relates to the use of CTLA4 agonist for treating or preventing adverse events in patient treated with an immune checkpoint inhibitor.

Core Innovation

The invention provides methods for treating an adverse event induced by treatment with an immune checkpoint inhibitor by administering an effective amount of abatacept to a patient in need thereof. The adverse event is a de novo adverse event induced by the immune checkpoint inhibitor and is not related to a preexisting immune condition in the patient treated with the immune checkpoint inhibitor. The described approach is directed to immune-related adverse events associated with immune checkpoint inhibitor therapy.

The methods further specify that the adverse event can be an immune-mediated disease, including myocarditis and other immune-mediated adverse events. The document emphasizes de novo events not linked to preexisting autoimmunity and particularly addresses T-cell/macrophage-driven myocarditis. The immune checkpoint inhibitors are described in terms of checkpoint inhibitor classes and named examples, including PD-1 inhibitors, PD-L1 inhibitors, anti-CTLA4, and combinations thereof.

In additional aspects, the document describes optional co-administration of an immunosuppressant with abatacept, where abatacept and the immunosuppressant are administered simultaneously, separately, or sequentially. The co-administered immunosuppressants are enumerated as including glucocorticoids and other immune suppressants. The document also describes methods for preventing an adverse event induced by immune checkpoint inhibitor treatment using abatacept under the same de novo and not-related-to-preexisting-immune-condition criteria.

Claims Coverage

The partial content includes three independent claims: one for treating a de novo immune checkpoint inhibitor–induced adverse event using abatacept, one for treating de novo myocarditis induced by an immune checkpoint inhibitor using abatacept, and one for preventing a de novo immune checkpoint inhibitor–induced adverse event using abatacept. Across these independent claims, the main inventive features are abatacept administration for de novo, non–preexisting-immune-condition adverse events, with myocarditis as a specific example and with optional co-administration of an immunosuppressant in dependent claims.

The independent claims collectively cover abatacept-based treating and preventing of de novo immune checkpoint inhibitor–induced adverse events that are not related to a preexisting immune condition, with one independent claim specifically limited to myocarditis. Dependent claims (in the partial content) refine the immune checkpoint inhibitor classes/drug examples and add optional co-administration of an immunosuppressant with abatacept using a simultaneously, separately, or sequentially timing relationship.

Stated Advantages

Documented Applications