Table 2.

Summary of primary, key secondary, and secondary efficacy outcomes (ITT set)

	Liso-cel (n = 92)	SOC (n = 92)	Liso-cel vs SOC
Primary efficacy end point per IRC
EFS			Stratified HR (95% CI)
Patients with events, n (%)	44 (48)	71 (77)	—
Median (95% CI) EFS, mo∗	NR (9.5-NR)	2.4 (2.2-4.9)	0.356 (0.243-0.522)
12-mo EFS rate, % (95% CI)†	57.1 (47.0-67.3)	22.5 (13.9-31.2)	—
18-mo EFS rate, % (95% CI)†	52.6 (42.3-62.9)	20.8 (12.2-29.5)	—
Key secondary efficacy end points
CR rate per IRC			Stratified 1-sided P value
CR, n (%); 95% CI‡	68 (74); 63.7-82.5	40 (43); 33.2-54.2	<.0001
PFS per IRC			Stratified HR (95% CI); P value§
Patients with events, n (%)	37 (40)	52 (57)	—
Median (95% CI) PFS, mo∗	NR (12.6-NR)	6.2 (4.3-8.6)	0.400 (0.261-0.615); <.0001
12-mo PFS rate, % (95% CI)†	63.1 (53.0-73.3)	31.2 (20.2-42.3)	—
18-mo PFS rate, % (95% CI)†	58.2 (47.7-68.7)	28.8 (17.7-40.0)	—
OS			Stratified HR (95% CI); P value§
Patients with events, n (%)	28 (30)	38 (41)	—
Median (95% CI) OS, mo∗	NR (29.5-NR)	29.9 (17.9-NR)	0.724 (0.443-1.183); .0987
12-mo OS rate, % (95% CI)†	83.4 (75.7-91.1)	72.0 (62.7-81.3)	—
18-mo OS rate, % (95% CI)†	73.1 (63.9-82.3)	60.6 (50.2-71.1)	—
Secondary efficacy end points per IRC
ORR
ORR, n (%); 95% CI‡	80 (87); 78.3-93.1	45 (49); 38.3-59.6	—
DOR			Stratified HR (95% CI)
Patients with events, n/N (%)	31/80 (39)	25/45 (56)	—
Median (95% CI) DOR, mo∗	NR (13.4-NR)	9.1 (5.1-NR)	0.579 (0.340-0.984)
Duration of CR
Patients with events, n/N (%)	21/68 (31)	21/40 (52.5)	—
Median (95% CI) DOR, mo∗	NR (NR-NR)	9.3 (5.1-NR)	0.483 (0.262-0.890)

All percentages are rounded to whole numbers except those with “.5%.”

— denotes not available or not reported.

^∗Median estimates of time to event were Kaplan-Meier product-limit estimates.

^†Based on Greenwood formula; 2-sided CI.

^‡Based on Cochran-Mantel-Haenszel test; 2-sided CI.

^§Based on a stratified Cox proportional hazards model; 1-sided P value.