ZUMA-7

Question 1

Pts Enrolled

N=__ (__ vs __)

USPI: N=__ (__ vs __)

Answer 1

Pts Enrolled

N=359 (180 vs 179)

USPI: N=359 (180 vs 179)

Question 2

Pts Collected

__ (__%)

USPI: __ (__%)

Answer 2

Pts Collected

178 (99%)

USPI: 178 (99%)

Question 3

Manufacturing Success

__%

USPI: __ pts got non-conforming products

Answer 3

Manufacturing Success

100%

USPI: 2 pts got non-conforming products

Question 4

Pts Infused

__ (__%)

USPI: Removal of __ pts from safety analysis set due to OOS

Answer 4

Pts Infused

170 (94%)

USPI: Removal of 2 pts from safety analysis set due to OOS

Question 5

Median time from leukapheresis to product release (days)

__ (__ North America, __ RoW)

USPI: __

Answer 5

Median time from leukapheresis to product release (days)

13 (12 North America, 19 RoW)

USPI: Not present in label

Question 6

Median time from leukapheresis to product delivery (days)

__ (__ North America, __ RoW)

USPI: __

Answer 6

Median time from leukapheresis to product delivery (days)

18 (17 North America, 29 RoW)

USPI: 18

Question 7

Median time from leukapheresis to infusion (days)

__ (__ North America, __ RoW)

USPI: __

Answer 7

Median time from leukapheresis to infusion (days)

26 (25 North America, 32 RoW)

USPI: 26

Question 8

Bridging

__% steroid only

USPI: __% steroid only

Answer 8

Bridging

36% steroid only

USPI: 33% steroid only

Question 9

SOC receiving HDT-ASCT

__%

USPI: __ % on-protocol HSCT (__ pts off-protocol)

Answer 9

SOC receiving HDT-ASCT

36%

USPI: 35% on-protocol HSCT (2 pts off-protocol)

Question 10

Median Age

__ years

Answer 10

Median Age

58 years

Question 11

>= 65 yr

__%

Answer 11

>= 65 yr

28%

Question 12

ECOG PS 1

__%

Answer 12

ECOG PS 1

47%

Question 13

Stage III or IV

__%

Answer 13

Stage III or IV

77%

Question 14

sAAIPI 2 or 3

__%

Answer 14

sAAIPI 2 or 3

46%

Question 15

GCB

__% central;
__% INV

Answer 15

GCB

61% central;
53% INV

Question 16

ABC, non-GCB

__% central;
__% INV

Answer 16

ABC, non-GCB

9% central;
26% INV

Question 17

Primary Refractory

__%

Answer 17

Primary Refractory

74%

Question 18

Relapsed less than 12mo

__%

Answer 18

Relapsed less than 12mo

26%

Question 19

DLBCL

__% central;
__% NOS INV

Answer 19

DLBCL

70% central;
61% NOS INV

Question 20

HGBL

__% central;
__% INV

Answer 20

HGBL

17% central;
24% INV

Question 21

T-cell– or histiocyte–rich LBCL

__% INV

Answer 21

T-cell– or histiocyte–rich LBCL

__% INV

Question 22

EBV–positive DLBCL

__% INV

Answer 22

EBV–positive DLBCL

1% INV

Question 23

Transformed iNHL

__% INV

Answer 23

Transformed iNHL

11% INV

Question 24

FL3b or PMBCL

__%

Answer 24

FL3b or PMBCL

0%

Question 25

Primary cutaneous DLBCL, leg type

__%

Answer 25

Primary cutaneous DLBCL, leg type

1%

Question 26

Secondary CNS Lymphoma

__%

Answer 26

Secondary CNS Lymphoma

0%

Question 27

Double Expressor

__%

Answer 27

Double Expressor

32%

Question 28

Median tumor burden (SPD)

__ mm2

Answer 28

Median tumor burden (SPD)

2123 mm2

Question 29

CD19+

__%

Answer 29

CD19+

80%

Question 30

Bone Marrow Involvement

__%

Answer 30

Bone Marrow Involvement

9%

Question 31

LDH

Elevated LDH: __%

Answer 31

LDH

Elevated LDH: 56%

Question 32

Crossover

__% off protocol (subsequent cellular immunotherapy)

USPI: __% off protocol (CD19-directed CAR T therapy)

Answer 32

Crossover

56% off protocol (subsequent cellular immunotherapy)

USPI: 55% off protocol (CD19-directed CAR T therapy)