Methods of treating gastrointestinal immune-related adverse events in immune oncology treatments
AssigneeTakeda Pharmaceutical Company Limited
InventorsRachael L. Brake, Eric H. Westin
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Abstract
The invention provides, inter alia, methods of reducing gastrointestinal immune-related adverse events, such as colitis and diarrhea, in subjects undergoing an immune treatment, such as an immune oncology treatment, such as anti-CTLA4 antibody and anti-PD-1 antibody combination treatment for melanoma. In certain aspects, the methods encompass administering a therapeutically effective amount of a polypeptide that inhibits MAdCAM-integrin binding, such as an anti-α4β7 integrin antibody, such vedolizumab or a related antibody.
Claims13
A method of treating a gastrointestinal immune-related adverse event (gi-irAE) in a human subject undergoing an immune oncology treatment comprising treatment with an anti-CTLA4 antibody and an anti-PD-1 antibody, said method comprising administering a therapeutically effective amount of a humanized anti-α4β7 integrin antibody to the human subject, such that the gi-irAE is treated,
- wherein the human subject has non-small cell lung cancer and is undergoing concurrent immune oncology treatment comprising treatment with an anti-CTLA4 antibody and an anti-PD-1 antibody,
- wherein the humanized anti-α4β7 integrin antibody is administered in response to symptoms of a gi-riAE comprising Grade 3 or 4 diarrhea,
- wherein the anti-α4β7 integrin antibody is an IgG1 antibody and comprises the complementarity determining regions (CDRs):
- Light chain:
- CDR1 SEQ ID NO:7
- CDR2 SEQ ID NO:8 and
- CDR3 SEQ ID NO:9;
- and
- Heavy chain:
- CDR1 SEQ ID NO:4
- CDR2 SEQ ID NO:5 and
- CDR3 SEQ ID NO:6, and
- wherein the subject exhibits no significant reduction of efficacy of the immune oncology treatment after administration of the anti-α4β7 integrin antibody.
Dependencies are inferred from the claim text.