Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp

Jessica C Hassel; Carola Berking; Andrea Forschner; Christoffer Gebhardt; Lucie Heinzerling; Friedegund Meier; Sebastian Ochsenreither; Jens Siveke; Axel Hauschild; Dirk Schadendorf

doi:10.1016/j.ejca.2023.112986

Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp

Standard

Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp. / Hassel, Jessica C; Berking, Carola; Forschner, Andrea; Gebhardt, Christoffer; Heinzerling, Lucie; Meier, Friedegund; Ochsenreither, Sebastian; Siveke, Jens; Hauschild, Axel; Schadendorf, Dirk.

in: EUR J CANCER, Jahrgang 191, 09.2023, S. 112986.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Hassel, JC, Berking, C, Forschner, A, Gebhardt, C, Heinzerling, L, Meier, F, Ochsenreither, S, Siveke, J, Hauschild, A & Schadendorf, D 2023, 'Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp', EUR J CANCER, Jg. 191, S. 112986. https://doi.org/10.1016/j.ejca.2023.112986

APA

Hassel, J. C., Berking, C., Forschner, A., Gebhardt, C., Heinzerling, L., Meier, F., Ochsenreither, S., Siveke, J., Hauschild, A., & Schadendorf, D. (2023). Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp. EUR J CANCER, 191, 112986. https://doi.org/10.1016/j.ejca.2023.112986

Vancouver

Hassel JC, Berking C, Forschner A, Gebhardt C, Heinzerling L, Meier F et al. Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp. EUR J CANCER. 2023 Sep;191:112986. https://doi.org/10.1016/j.ejca.2023.112986

Bibtex

@article{222cb1c84a634fd7827b551c506b3ced,

title = "Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp",

abstract = "Tebentafusp is a new T cell receptor bispecific fusion protein and the first approved treatment option for human leucocyte antigen-A*02:01 (HLA-A*02:01) metastatic uveal melanoma, with a proven benefit in overall survival versus the investigator's choice. As a first-in-class therapeutic option, this Immune mobilising monoclonal T cell receptor Against Cancer (ImmTAC) is associated with a new adverse event (AE) profile. Based on clinical experience, a national expert group discussed recommendations for tebentafusp treatment, focusing on AE management. Further topics included prerequisites for initiating tebentafusp treatment, appropriate treatment setting, and patient selection criteria. To provide guidance for treating physicians, the resulting recommendations are summarised including a model standard operating procedure for AE management. Patients in good clinical condition and with a low tumour burden are good candidates for tebentafusp treatment, particularly if treated as early as possible after the diagnosis of metastatic disease. The safety profile of tebentafusp is manageable and includes two major pathologies: cytokine release syndrome (CRS) and skin-related events. Postdose monitoring should thus focus on pyrexia and hypotension as the first symptoms of cytokine release. To minimise the risk of hypotension associated with CRS, patients should receive intravenous fluids before starting treatment. The monitoring of liver values is crucial, as patients may experience an increase in transaminases, which can even manifest as tumour lysis syndrome.",

keywords = "Humans, Cytokines, Hypotension, Neoplasms, Second Primary, T-Lymphocytes",

author = "Hassel, {Jessica C} and Carola Berking and Andrea Forschner and Christoffer Gebhardt and Lucie Heinzerling and Friedegund Meier and Sebastian Ochsenreither and Jens Siveke and Axel Hauschild and Dirk Schadendorf",

year = "2023",

month = sep,

doi = "10.1016/j.ejca.2023.112986",

language = "English",

volume = "191",

pages = "112986",

journal = "EUR J CANCER",

issn = "0959-8049",

publisher = "Elsevier Limited",

}

RIS

TY - JOUR

T1 - Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp

AU - Hassel, Jessica C

AU - Berking, Carola

AU - Forschner, Andrea

AU - Gebhardt, Christoffer

AU - Heinzerling, Lucie

AU - Meier, Friedegund

AU - Ochsenreither, Sebastian

AU - Siveke, Jens

AU - Hauschild, Axel

AU - Schadendorf, Dirk

PY - 2023/9

Y1 - 2023/9

N2 - Tebentafusp is a new T cell receptor bispecific fusion protein and the first approved treatment option for human leucocyte antigen-A*02:01 (HLA-A*02:01) metastatic uveal melanoma, with a proven benefit in overall survival versus the investigator's choice. As a first-in-class therapeutic option, this Immune mobilising monoclonal T cell receptor Against Cancer (ImmTAC) is associated with a new adverse event (AE) profile. Based on clinical experience, a national expert group discussed recommendations for tebentafusp treatment, focusing on AE management. Further topics included prerequisites for initiating tebentafusp treatment, appropriate treatment setting, and patient selection criteria. To provide guidance for treating physicians, the resulting recommendations are summarised including a model standard operating procedure for AE management. Patients in good clinical condition and with a low tumour burden are good candidates for tebentafusp treatment, particularly if treated as early as possible after the diagnosis of metastatic disease. The safety profile of tebentafusp is manageable and includes two major pathologies: cytokine release syndrome (CRS) and skin-related events. Postdose monitoring should thus focus on pyrexia and hypotension as the first symptoms of cytokine release. To minimise the risk of hypotension associated with CRS, patients should receive intravenous fluids before starting treatment. The monitoring of liver values is crucial, as patients may experience an increase in transaminases, which can even manifest as tumour lysis syndrome.

AB - Tebentafusp is a new T cell receptor bispecific fusion protein and the first approved treatment option for human leucocyte antigen-A*02:01 (HLA-A*02:01) metastatic uveal melanoma, with a proven benefit in overall survival versus the investigator's choice. As a first-in-class therapeutic option, this Immune mobilising monoclonal T cell receptor Against Cancer (ImmTAC) is associated with a new adverse event (AE) profile. Based on clinical experience, a national expert group discussed recommendations for tebentafusp treatment, focusing on AE management. Further topics included prerequisites for initiating tebentafusp treatment, appropriate treatment setting, and patient selection criteria. To provide guidance for treating physicians, the resulting recommendations are summarised including a model standard operating procedure for AE management. Patients in good clinical condition and with a low tumour burden are good candidates for tebentafusp treatment, particularly if treated as early as possible after the diagnosis of metastatic disease. The safety profile of tebentafusp is manageable and includes two major pathologies: cytokine release syndrome (CRS) and skin-related events. Postdose monitoring should thus focus on pyrexia and hypotension as the first symptoms of cytokine release. To minimise the risk of hypotension associated with CRS, patients should receive intravenous fluids before starting treatment. The monitoring of liver values is crucial, as patients may experience an increase in transaminases, which can even manifest as tumour lysis syndrome.

KW - Humans

KW - Cytokines

KW - Hypotension

KW - Neoplasms, Second Primary

KW - T-Lymphocytes

U2 - 10.1016/j.ejca.2023.112986

DO - 10.1016/j.ejca.2023.112986

M3 - SCORING: Journal article

C2 - 37595494

VL - 191

SP - 112986

JO - EUR J CANCER

JF - EUR J CANCER

SN - 0959-8049

ER -