Table 2.
Tumor response based on investigator assessment. a Tumor response in the overall cohort; b objective response rate in molecular DLBCL subtypes in the overall cohort and PPS.
| (A) Tumor response in the overall cohort | ||||||||
|---|---|---|---|---|---|---|---|---|
| Total N = 67 |
CD79B mutational status n = 67 |
DLBCL COO subgroup n = 67 |
||||||
| Mutant CD79B n = 9 |
Wild-type CD79B n = 45 |
Missing n = 13 |
ABC DLBCL n = 19 |
GCB DLBCL n = 30 |
Unclassifiable n = 3 |
Missing n = 15 |
||
| Best overall response, n (%) | ||||||||
| CR | 5 (7.5) | 1 (11.1) | 4 (8.9) | 0 | 4 (21.1) | 1 (3.3) | 0 | 0 |
| PR | 8 (11.9) | 1 (11.1) | 5 (11.1) | 2 (15.4) | 2 (10.5) | 3 (10.0) | 1 (33.3) | 2 (13.3) |
| Stable disease | 14 (20.9) | 3 (33.3) | 9 (20.0) | 2 (15.4) | 4 (21.1) | 8 (26.7) | 0 | 2 (13.3) |
| Progressive disease | 30 (44.8) | 4 (44.4) | 17 (37.8) | 9 (69.2) | 7 (36.8) | 13 (43.3) | 2 (66.7) | 8 (53.3) |
| Not evaluable/not availablea | 10 (14.9) | 0 | 10 (22.2) | 0 | 2 (10.5) | 5 (16.7) | 0 | 3 (20.0) |
| ORR, n (%) | 13 (19.4) | 2 (22.2) | 9 (20.0) | 2 (15.4) | 6 (31.6) | 4 (13.3) | 1 (33.3) | 2 (13.3) |
| 90% CI | 11.9, 29.1 | 4.1, 55.0 | 10.9, 32.3 | 2.8, 41.0 | 14.7, 53.0 | 4.7, 28.0 | 1.7, 86.5 | 2.4, 36.3 |
| DCR, n (%) | 27 (40.3) | 5 (55.6) | 18 (40.0) | 4 (30.8) | 10 (52.6) | 12 (40.0) | 1 (33.3) | 4 (26.7) |
| (B) Objective response rate in molecular DLBCL subtypes in the overall cohort and PPS | ||||||
|---|---|---|---|---|---|---|
| Biomarker | Overall cohort | PPS | ||||
| ORR, % | ORR difference, % (90% CI) | P value | ORR, % | ORR difference, % (90% CI) | P value | |
| ABC vs. GCB | 31.6 vs. 13.3 | 18.2 (−6.1, 41.0) | 0.1413 | 37.5 vs. 13.6 | 23.9 (−3.3, 48.3) | 0.1074 |
| ABC vs. GCB plus unclassifiable | 31.6 vs. 15.2 | 16.4 (−7.2, 39.1) | 0.1751 | 37.5 vs. 16.7 | 20.8 (−6.8, 46.2) | 0.1638 |
| GCB vs. ABC plus unclassifiable | 13.3 vs. 31.8 | −18.5 (−40.1, 4.6) | 0.1329 | 13.6 vs. 38.9 | −25.3 (−49.1, 1.1) | 0.0762 |
| Unclassifiableb | 33.3 | 50.0 | ||||
ABC activated B-cell like, CI confidence interval, COO cell of origin, CR complete response, DLBCL diffuse large B-cell lymphoma, GCB germinal center B-cell like, ORR objective response rate, PPS per-protocol set, PR partial response.
aOne patient had postbaseline tumor assessment(s) that could not be evaluated by the investigator and nine patients had no postbaseline tumor assessment due to discontinuation because of progression by clinical judgement, death occurring before disease was reevaluated, or other reasons; these ten patients were considered nonresponders.
bOverall cohort, n = 3; PPS, n = 2; no statistical comparisons reported due to small sample size.