Characteristics of second primary malignancies following bispecific antibodies therapy
Background The risk of secondary primary malignancies (SPMs) associated with bispecific antibody (BsAb)—a promising alternative to chimeric antigen receptor (CAR)-T therapy—remains insufficiently explored.Methods Using large-scale, real-world data from the US Food and Drug Administration’s Adverse E...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2025-04-01
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| Series: | Journal for ImmunoTherapy of Cancer |
| Online Access: | https://jitc.bmj.com/content/13/4/e011200.full |
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| author | Dan Liu Tong Li Liang Wang Jia Guo Xinyu Zhou Hongsheng Zhou Xiaojie Liang Baiwei Luo Bingyu Lin WeiXiang Lu Shengyu Tian Zihong Cai Zhihao Jin Keren Chen |
| author_facet | Dan Liu Tong Li Liang Wang Jia Guo Xinyu Zhou Hongsheng Zhou Xiaojie Liang Baiwei Luo Bingyu Lin WeiXiang Lu Shengyu Tian Zihong Cai Zhihao Jin Keren Chen |
| author_sort | Dan Liu |
| collection | DOAJ |
| description | Background The risk of secondary primary malignancies (SPMs) associated with bispecific antibody (BsAb)—a promising alternative to chimeric antigen receptor (CAR)-T therapy—remains insufficiently explored.Methods Using large-scale, real-world data from the US Food and Drug Administration’s Adverse Event Reporting System, we identified the relative frequency and characteristics of SPMs following BsAbs therapy and conducted a comprehensive comparison of treatment-related SPM profiles between BsAbs and CAR-T therapies.Results We identified 108 cases among 10,280 BsAb-treated patients. The incidence risk of SPMs was stable over the past 8 years, accounting for 1–2% of all adverse events, with a case fatality rate of 29.63% among the SPM cases. Myeloid leukemias and non-Hodgkin’s lymphoma were more frequent in blinatumomab recipients, while solid malignancies predominated in those treated with teclistamab. Time-to-onset (TTO) was significantly shorter in BsAb recipients compared with non-recipients, with weight and treatment duration influencing TTO, while no significant differences in TTO were observed across different BsAb products, ages, and genders. Our findings highlight the first year of BsAbs as a critical window for early detection and intervention. Although the overall risk of SPMs was lower with BsAbs than with CAR-T, the outcomes of SPMs were comparable in both groups. TTO and SPM patterns were statistically similar between the two therapies.Conclusion Our study provides the first detailed characterization of SPMs post-BsAb, underscoring the need for continued pharmacovigilance and individualized risk management to mitigate SPM risks in patients undergoing BsAb therapy. |
| format | Article |
| id | doaj-art-a8db603cbb5c470e9709d85391d5a82c |
| institution | DOAJ |
| issn | 2051-1426 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Journal for ImmunoTherapy of Cancer |
| spelling | doaj-art-a8db603cbb5c470e9709d85391d5a82c2025-08-20T03:08:06ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262025-04-0113410.1136/jitc-2024-011200Characteristics of second primary malignancies following bispecific antibodies therapyDan Liu0Tong Li1Liang Wang2Jia Guo3Xinyu Zhou4Hongsheng Zhou5Xiaojie Liang6Baiwei Luo7Bingyu Lin8WeiXiang Lu9Shengyu Tian10Zihong Cai11Zhihao Jin12Keren Chen133 Department of Radiology, Shunde Hospital, Southern Medical University, Foshan, China5 Stomatological Hospital, School of Stomatology, Southern Medical University, Guangzhou, China1 Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China1 Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China4 The First School of Clinical Medicine, Guangdong Medical University, Zhanjiang, China2 Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China1 Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China2 Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China2 Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China1 Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China1 Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China2 Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China4 The First School of Clinical Medicine, Guangdong Medical University, Zhanjiang, China6 Department of General Medicine, Maoming People’s Hospital, Maoming, ChinaBackground The risk of secondary primary malignancies (SPMs) associated with bispecific antibody (BsAb)—a promising alternative to chimeric antigen receptor (CAR)-T therapy—remains insufficiently explored.Methods Using large-scale, real-world data from the US Food and Drug Administration’s Adverse Event Reporting System, we identified the relative frequency and characteristics of SPMs following BsAbs therapy and conducted a comprehensive comparison of treatment-related SPM profiles between BsAbs and CAR-T therapies.Results We identified 108 cases among 10,280 BsAb-treated patients. The incidence risk of SPMs was stable over the past 8 years, accounting for 1–2% of all adverse events, with a case fatality rate of 29.63% among the SPM cases. Myeloid leukemias and non-Hodgkin’s lymphoma were more frequent in blinatumomab recipients, while solid malignancies predominated in those treated with teclistamab. Time-to-onset (TTO) was significantly shorter in BsAb recipients compared with non-recipients, with weight and treatment duration influencing TTO, while no significant differences in TTO were observed across different BsAb products, ages, and genders. Our findings highlight the first year of BsAbs as a critical window for early detection and intervention. Although the overall risk of SPMs was lower with BsAbs than with CAR-T, the outcomes of SPMs were comparable in both groups. TTO and SPM patterns were statistically similar between the two therapies.Conclusion Our study provides the first detailed characterization of SPMs post-BsAb, underscoring the need for continued pharmacovigilance and individualized risk management to mitigate SPM risks in patients undergoing BsAb therapy.https://jitc.bmj.com/content/13/4/e011200.full |
| spellingShingle | Dan Liu Tong Li Liang Wang Jia Guo Xinyu Zhou Hongsheng Zhou Xiaojie Liang Baiwei Luo Bingyu Lin WeiXiang Lu Shengyu Tian Zihong Cai Zhihao Jin Keren Chen Characteristics of second primary malignancies following bispecific antibodies therapy Journal for ImmunoTherapy of Cancer |
| title | Characteristics of second primary malignancies following bispecific antibodies therapy |
| title_full | Characteristics of second primary malignancies following bispecific antibodies therapy |
| title_fullStr | Characteristics of second primary malignancies following bispecific antibodies therapy |
| title_full_unstemmed | Characteristics of second primary malignancies following bispecific antibodies therapy |
| title_short | Characteristics of second primary malignancies following bispecific antibodies therapy |
| title_sort | characteristics of second primary malignancies following bispecific antibodies therapy |
| url | https://jitc.bmj.com/content/13/4/e011200.full |
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