Table 3.

Efficacy of combination duv/romi in multicenter R/R cohort

Outcome measureAll (N = 38)Lead-in duv (n = 10)No lead-in duv (n = 28)nTFH subtype (including AITL) (n = 17)Non-nTFH subtype (n = 21)AITL (n = 13)PTCL-NOS (n = 14)CTCL (n = 3)ALK– ALCL (n = 1)ENKTCL (n = 1)ATLL (n = 1)HSTCL (n = 1)
Treatment response, n (%)             
OR∗  23 (61) 5 (50) 18 (64) 14 (82) 9 (43) 11 (85) 5 (36) 2 (67) 1 (100) 1 (100) 0 0 
CR 18 (47) 4 (40) 14 (50) 12 (71) 6 (29) 11 (85) 4 (29) 0 1 (100) 1 (100) 0 0 
PR 5 (13) 1 (10) 4 (14) 2 (12) 3 (14) 0 1 (7) 2 (67) 0 0 0 0 
SD 2 (5) 1 (10) 1 (4) 0 2 (10) 0 2 (14) 0 0 0 0 0 
PD 13 (34) 4 (40) 9 (32) 3 (18) 10 (48) 2 (15) 7 (50) 1 (33) 0 0 1 (100) 1 (100) 
Survival probability, mo             
T = 0: best response date             
OS        All other subtypes: 
Median (95% CI) 13 (6.9 to NR)   13 (3.2 to NR) 7.3 (4.1 to NR) 13 (3.2 to NR) NR (1.6 to NR) 6.9 (1.8 to NR) 
S(t) at t = 6 (95% CI) 0.7 (0.5-0.8)   0.7 (0.5-1.0) 0.6 (0.5-0.9) 0.7 (0.5-1.0) 0.6 (0.4-0.9) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.6 (0.4-0.8)   0.7 (0.5-1.0) 0.5 (0.3-0.8) 0.7 (0.5-1.0) 0.5 (0.3-0.9) 0.4 (0.1-1.0) 
S(t) at t = 24 (95% CI) 0.5 (0.3-0.8)   0.5 (0.2-1.0) 0.5 (0.3-0.8) 0.5 (0.2-1.0) - 0.4 (0.1-1.0) 
OS, allo-HSCT–censored             
Median (95% CI) 7.3 (4.1 to NR)   13 (3.2 to NR) 6.9 (4.1 to NR) 13 (3.2 to NR) 7.3 (1.6 to NR) 6.9 (1.8 to NR) 
S(t) at t = 6 (95% CI) 0.6 (0.4-0.8)   0.6 (0.3-1.0) 0.6 (0.4-0.9) 0.6 (0.3-1.0) 0.5 (0.3-1.0) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.4 (0.3-0.8)   0.6 (0.3-1.0) 0.3 (0.1-0.9) 0.6 (0.3-1.0) 0.4 (0.1-1.0) — 
PFS             
Median (95% CI) 2.8 (1.1 to NR)   21 (2.3 to NR) 1.7 (0 to NR) 21 (8.6 to NR) 0.9 (0 to NR) NR (0 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.4-0.7)   0.7 (0.5-1.0) 0.3 (0.2-0.6) 0.8 (0.6-1.0) 0.3 (0.1-0.7) 0.5 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.3 (0.2-0.6)   0.6 (0.3-1.0) 0.2 (0.1-0.6) 0.6 (0.4-1.0) 0.1 (0.02-0.7) 0.5 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.2 (0.04-0.8)   — 0.2 (0.1-0.6) — — 0.5 (0.3-1.0) 
PFS, allo-HSCT–censored             
Median (95% CI) 1.8 (1.1 to NR)   8.6 (1.3 to NR) 1.1 (0 to NR) 8.6 (2.3 to NR) 0.9 (0 to NR) 1.1 (0 to NR) 
S(t) at t = 6 (95% CI) 0.4 (0.2-0.6)   — — — — — 
S(t) at t = 12 (95% CI) 0.2 (0.04-0.8)   — — — — — 
T = 0: treatment start date             
OS             
Median (95% CI) 16 (9.5 to NR)   16 (9.5 to NR) NR (8.0 to NR) 16 (9.5 to NR) NR (8.3 to NR) NR (3.6 to NR) 
S(t) at t = 6 (95% CI) 0.7 (0.6-0.9)   0.8 (0.6-1.0) 0.7 (0.5-0.9) 0.8 (0.6-1.0) 0.7 (0.5-1.0) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.6 (0.4-0.8)   0.7 (0.5-1.0) 0.5 (0.3-0.8) 0.7 (0.5-1.0) 0.5 (0.3-0.9) 0.5 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.5 (0.3-0.8)   0.5 (0.2-1.0) 0.5 (0.3-0.8) 0.4 (0.2-1.0) 0.5 (0.3-0.9) 0.5 (0.3-1.0) 
OS, allo-HSCT–censored             
Median (95% CI) 9.7 (8.3 to NR)   16 (9.5 to NR) 8.3 (8.0 to NR) 16 (9.5 to NR) 9.7 (3.3 to NR) 8.0 (3.6 to NR) 
S(t) at t = 6 (95% CI) 0.7 (0.6-0.9)   0.8 (0.6-1.0) 0.7 (0.5-0.9) 0.8 (0.6-1.0) 0.7 (0.5-1.0) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.5 (0.3-0.8)   0.6 (0.4-1.0) 0.4 (0.2-0.8) 0.6 (0.3-1.0) 0.3 (0.1-1.0) — 
S(t) at t = 24 (95% CI) 0.3 (0.1-0.8)   0.3 (0.1-1.0) 0.4 (0.2-0.8) 0.3 (0.1-1.0) 0.3 (0.1-1.0) — 
PFS             
Median (95% CI) 8.6 (3.0 to NR)   23 (8.6 to NR) 3.3 (2.2 to NR) 23 (11 to NR) 3.0 (1.7 to NR) NR (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.4-0.7)   0.8 (0.6-1.0) 0.4 (0.2-0.6) 0.8 (0.7-1.0) 0.2 (0.1-0.6) 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.4 (0.2-0.6)   0.6 (0.3-0.9) 0.2 (0.1-0.6) 0.6 (0.4-1.0) 0.1 (0.02-0.7) 0.6 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.3 (0.1-0.6)   0.3 (0.1-1.0) 0.2 (0.1-0.6) 0.3 (0.1-1.0) — 0.6 (0.3-1.0) 
PFS, allo-HSCT–censored             
Median (95% CI) 5.0 (3.0 to NR)   11 (8.6 to NR) 3.3 (2.2 to NR) 11 (8.6 to NR) 3.0 (1.7 to NR) 6.5 (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.3-0.7)   0.7 (0.5-1.0) 0.3 (0.1-0.7) 0.8 (0.7-1.0) — 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
S(t) at t = 24 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
EFS             
Median (95% CI) 4.5 (2.8 to NR)   23 (8.6 to NR) 3.0 (2.2 to NR) 23 (8.6 to NR) 2.8 (1.7 to NR) NR (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.3-0.7)   0.7 (0.5-1.0) 0.3 (0.1-0.6) 0.8 (0.6-1.0) 0.2 (0.04-0.6) 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.3 (0.2-0.6)   0.5 (0.3-0.9) 0.2 (0.03-0.7) 0.6 (0.3-1.0) — 0.6 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) 0.2 (0.03-0.7) 0.3 (0.1-1.0) — 0.6 (0.3-1.0) 
EFS, allo-HSCT–censored             
Median (95% CI) 5.0 (3.0 to NR)   11 (8.6 to NR) 3.3 (2.2 to NR) 11 (8.6 to NR) 3.0 (1.7 to NR) 6.5 (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.3-0.7)   0.7 (0.5-1.0) 0.3 (0.1-0.1) 0.8 (0.7-1.0) — 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
S(t) at t = 24 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
Duration, mo             
TTNT,† median (95% CI) 17 (6.4 to NR) 11 (11 to NR) 17 (3.7 to NR) 25 (11 to NR) 6.4 (2.5 to NR) 25 (25 to NR) 6.4 (3.5 to NR) 6.5 (2.3 to NR) 
Time of follow-up,‡ median (95% CI) 11 (9.5-17) 18 (10 to NR) 11 (8.5 to 17) 11 (8.5 to NR) 11 (8.2 to NR) 12 (9.5 to NR) 14 (7.5 to NR) 10 (8.2 to NR) 
 (n = 23) (n = 5) (n = 18) (n = 14) (n = 9) (n = 11) (n = 5) (n = 4) 
TTR,§ median (IQR) 1.9 (1.7-2.6) 2.4 (2.3-5.6) 1.8 (1.7-2.2) 2.0 (1.8-2.8) 1.8 (1.5-2.3) 2.1 (1.7-2.6) 1.5 (1.4-1.8) 2.1 (1.8-3.1) 
DoR,|| median (95% CI) 21 (11 to NR) 8.6 (2.3 to NR) 21 (11 to NR) 21 (8.6 to NR) 11 (11 to NR) 21 (8.6 to NR) 11 (1.8 to NR) NR (0.9 to NR) 
Allo-HSCT consolidation after duv/romi, n (%)             
Immediately following (including bridging therapy) 11 (29) 1 (10) 10 (36) 6 (35) 5 (24) 5 (38) 3 (21) 2 (29) 
Any time following (including future therapy lines) 14 (37) 2 (20) 12 (43) 7 (41) 7 (33) 5 (38) 4 (29) 3 (43) 
Outcome measureAll (N = 38)Lead-in duv (n = 10)No lead-in duv (n = 28)nTFH subtype (including AITL) (n = 17)Non-nTFH subtype (n = 21)AITL (n = 13)PTCL-NOS (n = 14)CTCL (n = 3)ALK– ALCL (n = 1)ENKTCL (n = 1)ATLL (n = 1)HSTCL (n = 1)
Treatment response, n (%)             
OR∗  23 (61) 5 (50) 18 (64) 14 (82) 9 (43) 11 (85) 5 (36) 2 (67) 1 (100) 1 (100) 0 0 
CR 18 (47) 4 (40) 14 (50) 12 (71) 6 (29) 11 (85) 4 (29) 0 1 (100) 1 (100) 0 0 
PR 5 (13) 1 (10) 4 (14) 2 (12) 3 (14) 0 1 (7) 2 (67) 0 0 0 0 
SD 2 (5) 1 (10) 1 (4) 0 2 (10) 0 2 (14) 0 0 0 0 0 
PD 13 (34) 4 (40) 9 (32) 3 (18) 10 (48) 2 (15) 7 (50) 1 (33) 0 0 1 (100) 1 (100) 
Survival probability, mo             
T = 0: best response date             
OS        All other subtypes: 
Median (95% CI) 13 (6.9 to NR)   13 (3.2 to NR) 7.3 (4.1 to NR) 13 (3.2 to NR) NR (1.6 to NR) 6.9 (1.8 to NR) 
S(t) at t = 6 (95% CI) 0.7 (0.5-0.8)   0.7 (0.5-1.0) 0.6 (0.5-0.9) 0.7 (0.5-1.0) 0.6 (0.4-0.9) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.6 (0.4-0.8)   0.7 (0.5-1.0) 0.5 (0.3-0.8) 0.7 (0.5-1.0) 0.5 (0.3-0.9) 0.4 (0.1-1.0) 
S(t) at t = 24 (95% CI) 0.5 (0.3-0.8)   0.5 (0.2-1.0) 0.5 (0.3-0.8) 0.5 (0.2-1.0) - 0.4 (0.1-1.0) 
OS, allo-HSCT–censored             
Median (95% CI) 7.3 (4.1 to NR)   13 (3.2 to NR) 6.9 (4.1 to NR) 13 (3.2 to NR) 7.3 (1.6 to NR) 6.9 (1.8 to NR) 
S(t) at t = 6 (95% CI) 0.6 (0.4-0.8)   0.6 (0.3-1.0) 0.6 (0.4-0.9) 0.6 (0.3-1.0) 0.5 (0.3-1.0) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.4 (0.3-0.8)   0.6 (0.3-1.0) 0.3 (0.1-0.9) 0.6 (0.3-1.0) 0.4 (0.1-1.0) — 
PFS             
Median (95% CI) 2.8 (1.1 to NR)   21 (2.3 to NR) 1.7 (0 to NR) 21 (8.6 to NR) 0.9 (0 to NR) NR (0 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.4-0.7)   0.7 (0.5-1.0) 0.3 (0.2-0.6) 0.8 (0.6-1.0) 0.3 (0.1-0.7) 0.5 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.3 (0.2-0.6)   0.6 (0.3-1.0) 0.2 (0.1-0.6) 0.6 (0.4-1.0) 0.1 (0.02-0.7) 0.5 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.2 (0.04-0.8)   — 0.2 (0.1-0.6) — — 0.5 (0.3-1.0) 
PFS, allo-HSCT–censored             
Median (95% CI) 1.8 (1.1 to NR)   8.6 (1.3 to NR) 1.1 (0 to NR) 8.6 (2.3 to NR) 0.9 (0 to NR) 1.1 (0 to NR) 
S(t) at t = 6 (95% CI) 0.4 (0.2-0.6)   — — — — — 
S(t) at t = 12 (95% CI) 0.2 (0.04-0.8)   — — — — — 
T = 0: treatment start date             
OS             
Median (95% CI) 16 (9.5 to NR)   16 (9.5 to NR) NR (8.0 to NR) 16 (9.5 to NR) NR (8.3 to NR) NR (3.6 to NR) 
S(t) at t = 6 (95% CI) 0.7 (0.6-0.9)   0.8 (0.6-1.0) 0.7 (0.5-0.9) 0.8 (0.6-1.0) 0.7 (0.5-1.0) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.6 (0.4-0.8)   0.7 (0.5-1.0) 0.5 (0.3-0.8) 0.7 (0.5-1.0) 0.5 (0.3-0.9) 0.5 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.5 (0.3-0.8)   0.5 (0.2-1.0) 0.5 (0.3-0.8) 0.4 (0.2-1.0) 0.5 (0.3-0.9) 0.5 (0.3-1.0) 
OS, allo-HSCT–censored             
Median (95% CI) 9.7 (8.3 to NR)   16 (9.5 to NR) 8.3 (8.0 to NR) 16 (9.5 to NR) 9.7 (3.3 to NR) 8.0 (3.6 to NR) 
S(t) at t = 6 (95% CI) 0.7 (0.6-0.9)   0.8 (0.6-1.0) 0.7 (0.5-0.9) 0.8 (0.6-1.0) 0.7 (0.5-1.0) 0.7 (0.4-1.0) 
S(t) at t = 12 (95% CI) 0.5 (0.3-0.8)   0.6 (0.4-1.0) 0.4 (0.2-0.8) 0.6 (0.3-1.0) 0.3 (0.1-1.0) — 
S(t) at t = 24 (95% CI) 0.3 (0.1-0.8)   0.3 (0.1-1.0) 0.4 (0.2-0.8) 0.3 (0.1-1.0) 0.3 (0.1-1.0) — 
PFS             
Median (95% CI) 8.6 (3.0 to NR)   23 (8.6 to NR) 3.3 (2.2 to NR) 23 (11 to NR) 3.0 (1.7 to NR) NR (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.4-0.7)   0.8 (0.6-1.0) 0.4 (0.2-0.6) 0.8 (0.7-1.0) 0.2 (0.1-0.6) 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.4 (0.2-0.6)   0.6 (0.3-0.9) 0.2 (0.1-0.6) 0.6 (0.4-1.0) 0.1 (0.02-0.7) 0.6 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.3 (0.1-0.6)   0.3 (0.1-1.0) 0.2 (0.1-0.6) 0.3 (0.1-1.0) — 0.6 (0.3-1.0) 
PFS, allo-HSCT–censored             
Median (95% CI) 5.0 (3.0 to NR)   11 (8.6 to NR) 3.3 (2.2 to NR) 11 (8.6 to NR) 3.0 (1.7 to NR) 6.5 (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.3-0.7)   0.7 (0.5-1.0) 0.3 (0.1-0.7) 0.8 (0.7-1.0) — 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
S(t) at t = 24 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
EFS             
Median (95% CI) 4.5 (2.8 to NR)   23 (8.6 to NR) 3.0 (2.2 to NR) 23 (8.6 to NR) 2.8 (1.7 to NR) NR (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.3-0.7)   0.7 (0.5-1.0) 0.3 (0.1-0.6) 0.8 (0.6-1.0) 0.2 (0.04-0.6) 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.3 (0.2-0.6)   0.5 (0.3-0.9) 0.2 (0.03-0.7) 0.6 (0.3-1.0) — 0.6 (0.3-1.0) 
S(t) at t = 24 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) 0.2 (0.03-0.7) 0.3 (0.1-1.0) — 0.6 (0.3-1.0) 
EFS, allo-HSCT–censored             
Median (95% CI) 5.0 (3.0 to NR)   11 (8.6 to NR) 3.3 (2.2 to NR) 11 (8.6 to NR) 3.0 (1.7 to NR) 6.5 (2.2 to NR) 
S(t) at t = 6 (95% CI) 0.5 (0.3-0.7)   0.7 (0.5-1.0) 0.3 (0.1-0.1) 0.8 (0.7-1.0) — 0.6 (0.3-1.0) 
S(t) at t = 12 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
S(t) at t = 24 (95% CI) 0.2 (0.1-0.6)   0.3 (0.1-1.0) — 0.4 (0.2-1.0) — — 
Duration, mo             
TTNT,† median (95% CI) 17 (6.4 to NR) 11 (11 to NR) 17 (3.7 to NR) 25 (11 to NR) 6.4 (2.5 to NR) 25 (25 to NR) 6.4 (3.5 to NR) 6.5 (2.3 to NR) 
Time of follow-up,‡ median (95% CI) 11 (9.5-17) 18 (10 to NR) 11 (8.5 to 17) 11 (8.5 to NR) 11 (8.2 to NR) 12 (9.5 to NR) 14 (7.5 to NR) 10 (8.2 to NR) 
 (n = 23) (n = 5) (n = 18) (n = 14) (n = 9) (n = 11) (n = 5) (n = 4) 
TTR,§ median (IQR) 1.9 (1.7-2.6) 2.4 (2.3-5.6) 1.8 (1.7-2.2) 2.0 (1.8-2.8) 1.8 (1.5-2.3) 2.1 (1.7-2.6) 1.5 (1.4-1.8) 2.1 (1.8-3.1) 
DoR,|| median (95% CI) 21 (11 to NR) 8.6 (2.3 to NR) 21 (11 to NR) 21 (8.6 to NR) 11 (11 to NR) 21 (8.6 to NR) 11 (1.8 to NR) NR (0.9 to NR) 
Allo-HSCT consolidation after duv/romi, n (%)             
Immediately following (including bridging therapy) 11 (29) 1 (10) 10 (36) 6 (35) 5 (24) 5 (38) 3 (21) 2 (29) 
Any time following (including future therapy lines) 14 (37) 2 (20) 12 (43) 7 (41) 7 (33) 5 (38) 4 (29) 3 (43) 

EFS, event-free survival; OR, overall response; PET, positron emission tomography; PR, partial response; S(t), survival probability; SD, stable disease; TTNT, time to next therapy; TTR, time to response.

∗

Response rates were measured at best PET response to duv/romi.

†

TTNT was measured from treatment start date to initiation of next line of therapy after duv/romi, only in patients who received a subsequent line of therapy after duv/romi. Patients who subsequently underwent stem cell transplantation were censored at that event date.

‡

Time of follow-up was measured from treatment initiation date to date of latest clinical update.

§

TTR was reported from treatment start date to date of first response, only in patients who achieved CR/PR to duv/romi.

‖

DoR was measured from date of first evaluable PET response to date of progression or last follow-up, only in patients who achieved CR/PR to duv/romi.

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