JP-2025516262-A5 -

Dates

Publication Date

20260508

Application Date

20230501

Description

The above general description and the following detailed description are illustrative and explanatory and are intended to provide further explanation of the claimed disclosure. Other purposes, advantages, and features will become apparent to those skilled in the art from the following brief description of the drawings and the detailed description of the disclosure. The present invention provides, for example, the following items: (Item 1) A method for treating cancer in a human subject requiring cancer treatment, comprising administering to the subject an anti-TIGIT antibody having reduced binding to one or more activated human FcγR compared to wild-type (WT) human IgG1, wherein the treatment results in a reduction of one or more adverse events compared to a similar treatment comprising an Fc-corresponding anti-TIGIT antibody. (Item 2) A method for treating cancer in a human subject requiring cancer treatment, comprising administering to the subject an anti-TIGIT antibody having reduced binding to one or more activated human FcγR compared to wild-type (WT) human IgG1, wherein the subject is less likely to experience one or more adverse events compared to treatment with an Fc-corresponding anti-TIGIT antibody. (Item 3) The method according to item 1 or 2, wherein the Fc-compatible anti-TIGIT antibody is selected from AB308, BMS-986207, tilagolumab, vivostrimab, etiglimab, osperimab, EOS-448, SEA-TGT, AGEN1777, AGEN1327, JS006, ralzapastutug, and an Fc-compatible version of dombanarimab containing the wild-type IgG1 Fc region. (Item 4) A method for treating cancer in a human subject requiring cancer treatment without significantly increasing the likelihood of adverse events compared to standard treatment, comprising administering to the subject an anti-TIGIT antibody, in combination with one or more additional therapies, having reduced binding to one or more activated human FcγR compared to wild-type (WT) human IgG1. (Item 5) A method for reducing one or more adverse events experienced by a human subject being treated for cancer with an anti-TIGIT antibody, comprising administering to the subject an anti-TIGIT antibody having reduced binding to one or more activated human FcγR compared to wild-type (WT) human IgG1. (Item 6) A method for reducing one or more adverse events experienced by a human subject being treated for cancer with an anti-TIGIT antibody and an additional immunotherapy agent, comprising administering to the subject an anti-TIGIT antibody having reduced binding to one or more activated human FcγR compared to wild-type (WT) human IgG1, and an additional immunotherapy agent. (Item 7) The method according to item 6, wherein the immunotherapy agent is a checkpoint inhibitor arbitrarily selected from ipilimumab, nivolumab, pembrolizumab, semiprimab, avelumab, durvalumab, atezolizumab, and zimberemab. (Item 8) The method according to any one of items 1 to 7, wherein the adverse event is a treatment-related adverse event, an adverse event occurring under treatment, an immune-related adverse event, a treatment-related immune-related adverse event, a treatment-related adverse event leading to discontinuation of treatment, a treatment-related adverse event leading to interruption of treatment, a serious adverse event leading to discontinuation of treatment, a serious adverse event leading to interruption of treatment, a serious adverse event, a serious adverse event of grade 3 or higher, or a treatment-related adverse event of grade 3 or higher. (Item 9) The aforementioned immune-related adverse events are (i) Skin or subcutaneous tissue disorders, gastrointestinal disorders, hepatobiliary disorders, endocrine disorders, or respiratory, thoracic or mediastinal disorders, (ii) Skin or subcutaneous tissue disorders, (iii) Rash, oral mucositis, dry mouth, colitis, diarrhea, hepatitis, pneumonia, endocrine disorders, hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency, diabetes, or combination thereof, (iv) Arthritis, hepatitis, hypothyroidism, hyperthyroidism, infusion-related reactions, maculopapular rash, pneumonia, itching, psoriasis, rash, facial swelling, or any combination thereof, (v) The method according to item 8, selected from injection-related reactions, maculopapular rash, pruritus, psoriasis, rash, or a combination thereof. (Item 10) A method for reducing one or more dose reductions, temporary interruptions, or discontinuations of treatment experienced by human subjects being treated for cancer with anti-TIGIT antibodies, comprising administering to the subject an anti-TIGIT antibody having reduced binding to one or more activated human FcγR compared to wild-type (WT) human IgG1. (Item 11) A method for reducing one or more dose reductions, temporary interruptions, or discontinuations of treatment experienced by a human subject being treated for cancer with an anti-TIGIT antibody and an additional immunotherapy agent, comprising administering to the subject an anti-TIGIT antibo