A predictable, manageable and well-tolerated safety profile[1]

Only 8 of 165 patients (4.8%)
discontinued treatment due to AEs.[1]

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[2][3]

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][3]

Nearly all CRS events occurred during the step-up dosing schedule – less than 3% of patients developed their first event during subsequent doses.[2][3]

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]

Neurological toxicities

Neurological toxicities were mostly low grade and manageable*[1]

Neurological toxicities

Most neurological toxicities were grade 1 and grade 2 (experienced by 8.5% and 5.5% of all patients, respectively).[4]

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%).[3][4]

Adapted from Moreau et al. 2022[4]

* Median follow up of 14.1 months

Infections and neutropenia

Grade 3 and 4 infections and neutropenia occurred in the MajesTEC-1 trial[1]

Infection
Monitoring and management of infections and HGG
Infections:
  • Patients should be monitored for signs and symptoms of infection prior to and during treatment, and treated appropriately – prophylactic antimicrobials should be administered according to local institutional guidelines[3]
  • The step-up dosing schedule should not be administered in patients with active infection[3]
  • Prior to starting treatment with TECVAYLI, antiviral prophylaxis should be considered for the prevention of herpes zoster virus reactivation per local institutional guidelines[3]
HGG:
  • HGG has been reported in patients receiving TECVAYLI - immunoglobulin levels should therefore be monitored during treatment[3]
  • Intravenous or subcutaneous immunoglobulin therapy was used to treat HGG in 39% of patients[3]
  • Patients should be treated according to local institutional guidelines, including infection precautions, antibiotic or antiviral prophylaxis and administration of immunoglobulin replacement[3]

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.

CP-412257 - November 2023