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) 
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.

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