Cancer medicine · 2025
Characterization and Management of Cytokine Release Syndrome From the MonumenTAL-1 Study of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
van de Donk Niels W C J, Chari Ajai, Martin Thomas, Krishnan Amrita, Rasche Leo, Ye Jing Christine, Popat Rakesh, Lipe Brea, Rodriguez Cesar, Schinke Carolina, Skerget Sheri, Vishwamitra Deeksha, Verona Raluca, Gong Jue, Singh Indrajeet, Campagna Michela, Masterson Tara, Hilder Brandi, Tolbert Jaszianne, Renaud Thomas, Smit M Damiette, Heuck Christoph, Mateos Maria-Victoria
Аннотация
INTRODUCTION: Cytokine release syndrome (CRS) is a common adverse event associated with T-cell redirection therapies (TCRT), including talquetamab, the first GPRC5D × CD3 bispecific antibody approved for relapsed/refractory multiple myeloma (RRMM). We describe CRS with talquetamab and implications for clinical practice.
METHODS: Patients without prior TCRT received talquetamab 0.4 mg/kg weekly (QW) and 0.8 mg/kg every other week (Q2W), with two or three step-up doses, respectively, plus pretreatment with a glucocorticoid, antihistamine, and antipyretic. A separate cohort of patients with prior TCRT received talquetamab at either the QW or Q2W schedule. CRS was graded per American Society for Transplantation and Cellular Therapy criteria and managed per study protocol.
RESULTS: Across talquetamab QW (n = 143), Q2W (n = 145), and prior TCRT (n = 51) cohorts, most CRS events occurred during step-up doses and were grade 1 or 2; grade 3 CRS events were rare. Approximately one-third of patients experienced more than one CRS event. Fewer patients experienced subsequent CRS events if tocilizumab was used versus not used to treat their first CRS event. Overall response rates with talquetamab were similar among patients with and without tocilizumab to manage CRS. Baseline characteristics were not associated with CRS incidence, recurrence, duration, or severity, whereas immune biomarkers showed some trends in association with CRS parameters.
CONCLUSION: CRS outcomes with talquetamab were consistent with those seen with other TCRT in RRMM, including teclistamab (BCMA×CD3 bispecific antibody), indicating a similar clinical approach, including early vigilance and prompt treatment of CRS.
TRIAL REGISTRATION: NCT03399799/NCT04634552.
METHODS: Patients without prior TCRT received talquetamab 0.4 mg/kg weekly (QW) and 0.8 mg/kg every other week (Q2W), with two or three step-up doses, respectively, plus pretreatment with a glucocorticoid, antihistamine, and antipyretic. A separate cohort of patients with prior TCRT received talquetamab at either the QW or Q2W schedule. CRS was graded per American Society for Transplantation and Cellular Therapy criteria and managed per study protocol.
RESULTS: Across talquetamab QW (n = 143), Q2W (n = 145), and prior TCRT (n = 51) cohorts, most CRS events occurred during step-up doses and were grade 1 or 2; grade 3 CRS events were rare. Approximately one-third of patients experienced more than one CRS event. Fewer patients experienced subsequent CRS events if tocilizumab was used versus not used to treat their first CRS event. Overall response rates with talquetamab were similar among patients with and without tocilizumab to manage CRS. Baseline characteristics were not associated with CRS incidence, recurrence, duration, or severity, whereas immune biomarkers showed some trends in association with CRS parameters.
CONCLUSION: CRS outcomes with talquetamab were consistent with those seen with other TCRT in RRMM, including teclistamab (BCMA×CD3 bispecific antibody), indicating a similar clinical approach, including early vigilance and prompt treatment of CRS.
TRIAL REGISTRATION: NCT03399799/NCT04634552.