ASH Clinical News ACN_4.9_Digital_Issue | Page 2
CAR T IS HERE
YESCARTA®, THE FIRST CAR T THERAPY FOR CERTAIN TYPES
OF RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA
The following data reflect results from the ZUMA-1 pivotal trial* 1
// PROVEN
EFFICACY
51%
Patients achieved a best
response of complete
remission (CR) (52/101)
NR
Response duration was not
reached at a median follow-up
of 7.9 months in patients who
achieved CR
VISIT
// CYTOKINE RELEASE
SYNDROME
// RAPID & RELIABLE
MANUFACTURING
13% 94% 17 DAYS
Grade ≥3 incidence
Overall incidence
Median turnaround time †
// NEUROLOGIC
TOXICITIES
99%
31% 87%
Grade ≥3 incidence
Overall incidence
Manufacturing success
of CAR T cells engineered
and expanded ex vivo
YESCARTAHCP.COM/CENTERS TO FIND A LIST OF AUTHORIZED TREATMENT CENTERS
* ZUMA-1 was an open-label, single-arm study in 101 adult patients who received YESCARTA ® therapy. Patients received lymphodepleting
chemotherapy prior to a single infusion of YESCARTA ® at a target dose of 2 x 10 6 viable CAR T cells/kg body weight (maximum of 2 x 10 8 viable
CAR T cells). Patients had refractory disease to their most recent therapy, or had relapsed within 1 year after autologous hematopoietic
stem cell transplantation.
†
The median time from leukapheresis to product delivery.
INDICATION
YESCARTA ® is a CD19-directed genetically modified
autologous T cell immunotherapy indicated for
the treatment of adult patients with relapsed or
refractory large B-cell lymphoma after two or more
lines of systemic therapy, including diffuse large
B-cell lymphoma (DLBCL) not otherwise specified,
primary mediastinal large B-cell lymphoma, high
grade B-cell lymphoma, and DLBCL arising from
follicular lymphoma.
Limitation of Use: YESCARTA ® is not indicated for the
treatment of patients with primary central nervous
system lymphoma.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES
• Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in
patients receiving YESCARTA ® . Do not administer YESCARTA ® to patients with active infection
or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab
or tocilizumab and corticosteroids.
• Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients
receiving YESCARTA ® , including concurrently with CRS or after CRS resolution. Monitor
for neurologic toxicities after treatment with YESCARTA ® . Provide supportive care and/or
corticosteroids as needed.
• YESCARTA ® is available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS) called the YESCARTA ® REMS.
Important Safety Information continued on adjacent page.
YESCARTA, the YESCARTA Logo, KITE, and the KITE Logo are trademarks of Kite Pharma, Inc. GILEAD is a trademark of Gilead Sciences, Inc.
© 2018 Kite Pharma | PRC-00394 03/2018