Lass than 5% discontinued treatment due to AEs[1]
Treatment-related AEs that occurred in ≥20% of patients[1][2]
Haematological adverse events
Haematological adverse events
Non-haematological adverse events
Non-haematological adverse events
As data continue to be collected from MajesTEC-1 trial, the values stated in the New England Journal of Medicines publication (Moreau et al. 2022) differ to those in the published SmPC. The SmPC contains the most recent information available for TECVAYLI™
Cytokine release syndrome (CRS)
Most CRS events experienced were low grade (grades 1 and 2) – less than one percent (0.6%) of events were grade 3, affecting only one patient, and no grade 4 or fatal events occurred[1][2]
The step-up dosing schedule, including required pretreatment medicines,* was used to mitigate the risk of severe CRS.[2]
Median time to CRS onset was 2 days (range: 1–6 days) after the most recent dose, and all were resolved with a median duration of 2 days (range: 1–9).[1][2]
Nearly all CRS events occurred during the step-up dosing schedule – less than 3% of patients developed their first event during subsequent doses.[1][2]
Treatment with supportive care, tocilizumab and/or corticosteroids should be instituted based on severity of CRS.[2]
*Pretreatment doses include corticosteroid (oral or intravenous dexamethasone 16 mg), antihistamine (oral or intravenous diphenhydramine 50 mg or equivalent) and antipyretic (oral or intravenous paracetamol 650 mg to 1,000 mg or equivalent)[2]
Adapted from Moreau et al. 2022[3]
Neurological toxicities
Neurological toxicities were mostly low grade and manageable*[1]
Most neurological toxicities were grade 1 and grade 2 (experienced by 8.5% and 5.5% of all patients, respectively).[3]
ICANS occurred in a small number of patients (3.0%; all grade 1 or 2) and most commonly manifested as confused state (1.2%) and dysgraphia (1.2%).[2]
Treatment-related headache was the most frequently reported neurotoxic event (8.0%), followed by ICANS (3.0%).[2][3]
Adapted from Moreau et al. 2022[3]
* Median follow up of 14.1 months
AE, adverse event; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; MM, multiple myeloma; MoA, mechanism of action; R/R, relapsed and refractory; VGPR, very good partial response
For further information regarding TECVAYLI including full indications, all adverse effects and data please refer to the Israeli MOH prescribing information: https://israeldrugs.health.gov.il/#!/byDrug
The data in this presentation is based on published clinical studies, please see references at the bottom of the slides/throughout the presentation.
