Efficacy parameter | ≥6 months of follow-up [8] | ≥1 year of follow-up |
---|---|---|
(N = 88) | (N = 88) | |
ORR (95% CI), % | 31.8 (21.9-43.1)a | 33.0 (23.3-43.8) |
Confirmed BOR, n (%) | ||
CR | 8 (9.1) | 10 (11.4) |
PR | 20 (22.7) | 19 (21.6) |
SD | 9 (10.2) | 9 (10.2) |
PD | 32 (36.4) | 32 (36.4) |
Non-CR/non-PD | 1 (1.1)b | 0 |
Not evaluablec | 18 (20.5) | 18 (20.5) |
Response durability | (n = 28) | (n = 29) |
Median DOR (95% CI), months | NE (8.3-NE) | NE (18.0-NE) |
Range | 2.8-17.5+ | 2.8-23.3+ |
6-month DRR (95% CI), %d | 29.1 (19.5-38.8) | 30.6 (20.9-40.3) |
Proportion of responses with duration ≥6 months (95% CI), %e | 92 (70-98) | 93 (74-98) |
Proportion of responses with duration ≥1 year (95% CI), %e | NA | 74 (53-87) |
Proportion of patients in response at 1 year (95% CI), %f | NA | 23.9 (15.4-34.1) |