TOXICITIES WERE EFFECTIVELY MANAGED1,2

KYMRIAH should be administered by health care providers experienced with immunocompromised patients and management of patients treated with KYMRIAH1
CYTOKINE RELEASE SYNDROME (CRS)1
CRS has been successfully managed with an established treatment algorithm1

57% of patients experienced CRS, which was the most common adverse event with KYMRIAH. Although manageable, severe or life-threatening events have been observed.

The safety profile of KYMRIAH appears more favourable in the real-world setting as seen in the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry3,4
CYTOKINE RELEASE SYNDROME diagram CYTOKINE RELEASE SYNDROME diagram
  • Tocilizumab is approved for the management of CAR-T therapy–induced CRS1
    • 1 dose of tocilizumab and emergency equipment must be available per patient prior to infusion
    • The treatment centre must have access to additional doses of tocilizumab within 8 hours
  • The median time to onset was 3 days after infusion, and the median duration was 8 days

NEUROTOXICITY1
Neurological events: low rate of grade 3/4 neurotoxicity, and most events occurred within 8 weeks of infusion and were transient

Manifestations of encephalopathy and/or delirium occurred in 20% of patients within 8 weeks after KYMRIAH infusion.

The safety profile of KYMRIAH appears more favourable in the real-world setting as seen in the CIBMTR Registry3,4
NEUROTOXICITY diagram NEUROTOXICITY diagram

MANAGEABLE SAFETY PROFILE1,2

KYMRIAH has a manageable safety profile, providing the option to administer infusions in either an inpatient or outpatient setting1
Adverse drug reactions observed in the ELIANA (ALL, N=79) and JULIET (DLBCL, N=115) trials1

KYMRIAH has a manageable safety profile, providing the option to administer infusions in either an inpatient or outpatient setting KYMRIAH has a manageable safety profile, providing the option to administer infusions in either an inpatient or outpatient setting

aInfections and infestations presented reflect high level group terms.

bHaemorrhage includes anal haemorrhage, blood urine present, catheter site haemorrhage, cerebral haemorrhage, conjunctival haemorrhage, contusion, cystitis haemorrhagic, duodenal ulcer haemorrhage, disseminated intravascular coagulation, epistaxis, eye contusion, gastrointestinal haemorrhage, gingival bleeding, haematochezia, haemarthrosis, haematemesis, haematuria, haemoptysis, large intestinal haemorrhage, melaena, menorrhagia, mouth haemorrhage, peritoneal haematoma, petechiae, pharyngeal haemorrhage, post procedural haemorrhage, pulmonary haemorrhage, purpura, retinal haemorrhage, traumatic haematoma, tumour haemorrhage, upper gastrointestinal haemorrhage and vaginal haemorrhage.

cHypogammaglobulinaemia includes immunoglobulins decreased, blood immunoglobulin A decreased, blood immunoglobulin G decreased, blood immunoglobulin M decreased, immunodeficiency, immunodeficiency common variable and hypogammaglobulinaemia.

dDelirium includes agitation, delirium, hallucination, hallucination visual, irritability and restlessness.

eSleep disorder includes sleep disorder, insomnia and nightmare.

fHeadache includes headache and migraine.

gEncephalopathy includes depressed level of consciousness, mental status changes, automatism, cognitive disorder, confusional state, disturbance in attention, encephalopathy, somnolence, lethargy, memory impairment, metabolic encephalopathy and thinking abnormal.

hDizziness includes dizziness, presyncope and syncope.

iPeripheral neuropathy includes paraesthesia, peripheral sensory neuropathy, neuropathy peripheral, hyperaesthesia and hypoaesthesia.

jTremor includes dyskinesia and tremor.

kMotor dysfunction includes muscle spasms, muscle twitching, myoclonus and myopathy.

lSeizure includes seizure, generalised tonic clonic seizures and status epilepticus.

mSpeech disorders includes speech disorders, dysarthria and aphasia.

nNeuralgia includes neuralgia and sciatica.

oAtaxia includes ataxia and dysmetria.

pVisual impairment includes vision blurred and visual impairment.

qArrhythmia includes atrial fibrillation, supraventricular tachycardia, tachycardia and ventricular extrasystoles.

rCardiac failure includes cardiac failure, left ventricular dysfunction, cardiac failure congestive and right ventricular dysfunction.

sHypotension includes hypotension and orthostatic hypotension.

tThrombosis includes deep vein thrombosis, embolism, pulmonary embolism, thrombosis, vena cava thrombosis and venous thrombosis.

uCough includes cough, productive cough and upper airway cough syndrome.

vDyspnoea includes dyspnoea, dyspnoea exertional, respiratory distress and respiratory failure.

wOropharyngeal pain includes oral pain and oropharyngeal pain.

xPulmonary oedema includes acute pulmonary oedema and pulmonary oedema.

yAbdominal pain includes abdominal pain, abdominal pain upper and abdominal discomfort.

zRash includes dermatitis, dermatitis acneiform, dermatitis contact, rash, rash maculopapular, rash papular and rash pruritic.

aaAcute kidney injury includes acute kidney injury, anuria, azotaemia, blood creatinine abnormal, blood creatinine increased, renal failure, renal tubular dysfunction and renal tubular necrosis.

bbFatigue includes fatigue and malaise.

ccOedema includes oedema peripheral, generalised oedema, localised oedema, face oedema and peripheral swelling.

ddPain includes pain and pain in extremity.

*Frequency is based on laboratory values. Patients are counted only for the worst grade observed post baseline.

References:
  1. Kymriah Summary of Product Characteristics. Novartis Pharma AG; 2021.
  2. Borchmann P, Tam CS, Jäger U, et al. An Updated Analysis of JULIET, a Global Pivotal Phase 2 Trial of Tisagenlecleucel in Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. S799. Orally presented at: Congress of the European Hematology Association; June 14-17, 2018. Stockholm, Sweden.
  3. Bachanova V, Westin J, Tam C, et al. Correlative analyses of cytokine release syndrome and neurological events in tisagenlecleucel-treated relapsed/refractory diffuse large B-cell lymphoma patients. Presented at: 15th International Conference on Malignant Lymphoma Annual Meeting; June 18-22, 2019; Lugano, Switzerland. Poster 254.
  4. Jaglowski S, Hu Z-H, Zhang Y, et al. Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for adults with diffuse large B-cell lymphoma (DLBCL): real world experience from the Center for International Blood and Marrow Transplant Research (CIBMTR) cellular therapy registry. Presented at: 62nd American Society of Hematology Annual Meeting. December 6-10, 2019; Orlando, FL.