ZUMA-7 Flashcards
Pts Enrolled
N=__ (__ vs __)
USPI: N=__ (__ vs __)
Pts Enrolled
N=359 (180 vs 179)
USPI: N=359 (180 vs 179)
Pts Collected
__ (__%)
USPI: __ (__%)
Pts Collected
178 (99%)
USPI: 178 (99%)
Manufacturing Success
__%
USPI: __ pts got non-conforming products
Manufacturing Success
100%
USPI: 2 pts got non-conforming products
Pts Infused
__ (__%)
USPI: Removal of __ pts from safety analysis set due to OOS
Pts Infused
170 (94%)
USPI: Removal of 2 pts from safety analysis set due to OOS
Median time from leukapheresis to product release (days)
__ (__ North America, __ RoW)
USPI: __
Median time from leukapheresis to product release (days)
13 (12 North America, 19 RoW)
USPI: Not present in label
Median time from leukapheresis to product delivery (days)
__ (__ North America, __ RoW)
USPI: __
Median time from leukapheresis to product delivery (days)
18 (17 North America, 29 RoW)
USPI: 18
Median time from leukapheresis to infusion (days)
__ (__ North America, __ RoW)
USPI: __
Median time from leukapheresis to infusion (days)
26 (25 North America, 32 RoW)
USPI: 26
Bridging
__% steroid only
USPI: __% steroid only
Bridging
36% steroid only
USPI: 33% steroid only
SOC receiving HDT-ASCT
__%
USPI: __ % on-protocol HSCT (__ pts off-protocol)
SOC receiving HDT-ASCT
36%
USPI: 35% on-protocol HSCT (2 pts off-protocol)
Median Age
__ years
Median Age
58 years
>= 65 yr
__%
>= 65 yr
28%
ECOG PS 1
__%
ECOG PS 1
47%
Stage III or IV
__%
Stage III or IV
77%
sAAIPI 2 or 3
__%
sAAIPI 2 or 3
46%
GCB
__% central;
__% INV
GCB
61% central;
53% INV
ABC, non-GCB
__% central;
__% INV
ABC, non-GCB
9% central;
26% INV
Primary Refractory
__%
Primary Refractory
74%
Relapsed less than 12mo
__%
Relapsed less than 12mo
26%
DLBCL
__% central;
__% NOS INV
DLBCL
70% central;
61% NOS INV
HGBL
__% central;
__% INV
HGBL
17% central;
24% INV
T-cell– or histiocyte–rich LBCL
__% INV
T-cell– or histiocyte–rich LBCL
__% INV
EBV–positive DLBCL
__% INV
EBV–positive DLBCL
1% INV
Transformed iNHL
__% INV
Transformed iNHL
11% INV
FL3b or PMBCL
__%
FL3b or PMBCL
0%
Primary cutaneous DLBCL, leg type
__%
Primary cutaneous DLBCL, leg type
1%
Secondary CNS Lymphoma
__%
Secondary CNS Lymphoma
0%
Double Expressor
__%
Double Expressor
32%
Median tumor burden (SPD)
__ mm2
Median tumor burden (SPD)
2123 mm2
CD19+
__%
CD19+
80%
Bone Marrow Involvement
__%
Bone Marrow Involvement
9%
LDH
Elevated LDH: __%
LDH
Elevated LDH: 56%
Crossover
__% off protocol (subsequent cellular immunotherapy)
USPI: __% off protocol (CD19-directed CAR T therapy)
Crossover
56% off protocol (subsequent cellular immunotherapy)
USPI: 55% off protocol (CD19-directed CAR T therapy)
