Table 2.
Immunohistochemistry |
Gene expression profiling |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
Overall |
GCB |
Non-GCB |
GCB |
ABC |
||||||
Len n = 51 | IC n = 51 | Len n = 23 | IC n = 25 | Len n = 28 | IC n = 26 | Len n = 14 | IC n = 16 | Len n = 11 | IC n = 16 | |
ORR, n (%) | 14 (27.5) | 6 (11.8) | 6 (26.1) | 3 (12.0) | 8 (28.6) | 3 (11.5) | 3 (21.4) | 2 (12.5) | 5 (45.5) | 3 (18.8) |
[95% CI]b | [15.9–41.7] | [4.4–23.9] | [10.2–48.4] | [2.5–31.2] | [13.2–48.7] | [2.4–30.2] | [4.7–50.8] | [1.6–38.3] | [16.7–76.6] | [4.0–45.6] |
P valuec | 0.079 | 0.279 | 0.179 | 0.642 | 0.206 | |||||
CRd, n (%) | 5 (9.8) | 1 (2.0) | 1 (4.3) | 0 (0.0) | 4 (14.3) | 1 (3.8) | 1 (7.1) | 0 (0.0) | 3 (27.3) | 1 (6.3) |
PR, n (%) | 9 (17.6) | 5 (9.8) | 5 (21.7) | 3 (12.0) | 4 (14.3) | 2 (7.7) | 2 (14.3) | 2 (12.5) | 2 (18.2) | 2 (12.5) |
SD, n (%) | 13 (25.5) | 11 (21.6) | 5 (21.7) | 7 (28.0) | 8 (28.6) | 4 (15.4) | 4 (28.6) | 3 (18.8) | 2 (18.2) | 3 (18.8) |
PD/death, n (%) | 24 (47.1) | 33 (64.7) | 12 (52.2) | 14 (56.0) | 12 (42.9) | 19 (73.1) | 7 (50.0) | 11 (68.8) | 4 (36.4) | 10 (62.5) |
Unknown, n (%) | 0 (0.0) | 1 (2.0) | 0 (0.0) | 1 (4.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
PFS, weeks | 13.6 | 7.9 | 10.1 | 9.0 | 15.1 | 7.1 | 13.2 | 7.1 | 82.0 | 6.2 |
HR (95% CI) | 0.64 (0.41-0.99) | 0.82 (0.43–1.57) | 0.50 (0.27-0.92) | 0.77 (0.35–1.68) | 0.44 (0.15–1.23) | |||||
P value | 0.041 | 0.550 | 0.021 | 0.506 | 0.105 | |||||
OS, weeks | 31.0 | 24.6 | 30.0 | 24.9 | 32.3 | 20.4 | 30.0 | 20.1 | 108.4 | 18.6 |
HR (95% CI) | 0.91 (0.59–1.41) | 1.23 (0.65–2.34) | 0.70 (0.38–1.30) | 1.12 (0.52–2.42) | 0.47 (0.17–1.33) | |||||
P value | 0.673 | 0.526 | 0.253 | 0.767 | 0.144 |
mITT population; defined as all randomized patients who had confirmed DLBCL and GCB or non-GCB subtype diagnosis and received ≥1 dose of study drug.
Exact CI based on binomial distribution.
P value derived from the Fisher exact test.
No CR unconfirmed observed.
Abbreviation: Len, lenalidomide