In patients with relapsed or refractory (R/R) mantle cell lymphoma
Guidance has been established for the management of CAR T-related adverse reactions1
18% of patients with R/R MCL experienced Grade 3 or higher CRS and 37% experienced Grade 3 or higher neurologic events in the primary analysis1
Summary of CRS and
neurologic events1-4
CRS
91% of patients (n=75/82)
experienced CRS
-
Key manifestations of CRS include
fever (99%), hypotension (60%),
hypoxia (37%), chills (33%),
tachycardia (37%), headache (24%),
fatigue (19%), nausea (13%),
alanine aminotransferase increased
(13%), aspartate aminotransferase
increased (12%), and diarrhea (11%) -
61% (n=50/82) of patients received
tocilizumab, 21% (n=17/82) received
vasopressors, and 24% (n=20/82)
received steroids for management
of CRS - There was one Grade 5 CRS event
Median Time
to Onset
Median
Duration
3 days
(range: 1-13)
10 days
(range: 1-50)
Neurologic events
81% of patients (n=66/82)
experienced neurologic events
-
The most common neurologic events
included encephalopathy (51%),
headache (35%), tremor (38%),
aphasia (23%), and delirium (16%) -
23% (n=19/82) of patients received
tocilizumab and 40% (n=33/82)
received steroids for management
of neurologic events -
There were no Grade 5 neurologic
events
Median Time
to Onset
Median
Duration
6 days
(range: 1-32)
21 days
(range: 2-454)
Median Time
to Onset
Median
Duration
CRS
91% of patients (n=75/82) experienced CRS
-
Key manifestations of CRS include fever (99%), hypotension
(60%), hypoxia (37%), chills (33%), tachycardia (37%),
headache (24%), fatigue (19%), nausea (13%), alanine
aminotransferase increased (13%), aspartate
aminotransferase increased (12%), and diarrhea (11%) -
61% (n=50/82) of patients received tocilizumab, 21%
(n=17/82) received vasopressors, and 24% (n=20/82)
received steroids for management of CRS - There was one Grade 5 CRS event
3 days
(range: 1-13)
10 days
(range: 1-50)
Neurologic events
81% of patients (n=66/82) experienced neurologic events
-
The most common neurologic events included
encephalopathy (51%), headache (35%), tremor (38%),
aphasia (23%), and delirium (16%) -
23% (n=19/82) of patients received tocilizumab and 40%
(n=33/82) received steroids for management of
neurologic events - There were no Grade 5 neurologic events
6 days
(range: 1-32)
21 days
(range: 2-454)
- Most CRS or neurologic events occurred early1
- 83% of all treated patients experienced the first CRS within the first 7 days after TECARTUS® infusion1
- 56% of all treated patients experienced the first neurologic event within the first 7 days after TECARTUS infusion1
- In ZUMA-2, 99% of CRS events (n=74/75) and 79% of neurologic events (n=52/66) resolved1,3,5
- 66% (n=54/82) of patients experienced CRS before neurologic events started1
- 6% (n=5/82) of patients who developed neurologic events did not have CRS1
- 10% (n=8/82) developed neurologic events after the resolution of CRS1
Most CRS and neurologic events in ZUMA-2 occurred early, were generally reversible, and were managed medically per established guidance1,6
Recommended monitoring based on the ZUMA-2 trial
Day 0 to Day 7
On-site monitoring
Monitored at ATC for signs and symptoms of CRS, neurologic events, and other adverse reactions1
Day 8 to Day 28
Post-discharge monitoring
Patients instructed to remain within proximity of the ATC1
After Day 28
Long-term follow-up
Patient returns to referring office for routine monitoring7
- In the ZUMA-2 trial, patients with Grade >1 treatment-related CRS or neurologic events remained hospitalized until the adverse
reaction resolved7
Guidance for monitoring and management of CAR T-related adverse reactions (CRS and neurologic events)1
Ensure that 2 doses of tocilizumab are available for each patient prior to infusion. For more information on CRS and neurologic events management, please see the full Prescribing Information for TECARTUS
Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic events occur at any time
Monitor patients daily for at least 7 days and 4 weeks postinfusion at the ATC for signs and symptoms of CRS and neurologic events. Please see TECARTUS full Prescribing Information for detailed adverse event management guidelines.
ATCs must ensure that healthcare providers who prescribe, dispense, or administer TECARTUS are trained in the management of CRS and neurologic toxicities1
ATC=Authorized Treatment Center; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; MCL=mantle cell lymphoma; R/R=relapsed or refractory.
References: 1. TECARTUS® (brexucabtagene autoleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Data on file. Kite Pharma, Inc; 2021. 3. Data on file. Kite Pharma, Inc; 2022. 4. Data on file [1]. Kite Pharma, Inc; 2020. 5. Data on file [2]. Kite Pharma, Inc; 2020. 6. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma. N Engl J Med. 2020;382(14):1331-1342. 7. Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle cell lymphoma – study protocol. N Engl J Med. 2020;1-47.