Summary of IRC-assessed disease responses by MZL subtypes (efficacy analysis set)
| . | Extranodal (MALT) (n = 25) . | Nodal (n = 25) . | Splenic (n = 12) . | Unknown∗ (n = 4) . | Total† (N = 66) . |
|---|---|---|---|---|---|
| ORR, % (95% CI)‡ | 64.0 (42.5-82.0) | 76.0 (54.9-90.6) | 66.7 (34.9-90.1) | 50.0 (6.8-93.2) | 68.2 (55.6-79.1) |
| Best overall response, n (%) | |||||
| CR | 10 (40.0) | 5 (20.0) | 1 (8.3) | 1 (25.0) | 17 (25.8) |
| PR | 6 (24.0) | 14 (56.0) | 7 (58.3) | 1 (25.0) | 28 (42.4) |
| Stable disease | 4 (16.0) | 5 (20.0) | 3 (25.0) | 1 (25.0) | 13 (19.7) |
| Progressive disease | 3 (12.0) | 1 (4.0) | 1 (8.3) | 1 (25.0) | 6 (9.1) |
| Nonprogressive disease§ | 1 (4.0) | 0 | 0 | 0 | 1 (1.5) |
| Discontinued study before first assessment | 1 (4.0) | 0 | 0 | 0 | 1 (1.5) |
| Median time to response, mo (IQR) | 2.8 (2.7-2.9) | 2.8 (2.7-3.8) | 3.6 (2.7-6.0) | 2.7 (2.6-2.8) | 2.8 (2.7-3.7) |
| . | Extranodal (MALT) (n = 25) . | Nodal (n = 25) . | Splenic (n = 12) . | Unknown∗ (n = 4) . | Total† (N = 66) . |
|---|---|---|---|---|---|
| ORR, % (95% CI)‡ | 64.0 (42.5-82.0) | 76.0 (54.9-90.6) | 66.7 (34.9-90.1) | 50.0 (6.8-93.2) | 68.2 (55.6-79.1) |
| Best overall response, n (%) | |||||
| CR | 10 (40.0) | 5 (20.0) | 1 (8.3) | 1 (25.0) | 17 (25.8) |
| PR | 6 (24.0) | 14 (56.0) | 7 (58.3) | 1 (25.0) | 28 (42.4) |
| Stable disease | 4 (16.0) | 5 (20.0) | 3 (25.0) | 1 (25.0) | 13 (19.7) |
| Progressive disease | 3 (12.0) | 1 (4.0) | 1 (8.3) | 1 (25.0) | 6 (9.1) |
| Nonprogressive disease§ | 1 (4.0) | 0 | 0 | 0 | 1 (1.5) |
| Discontinued study before first assessment | 1 (4.0) | 0 | 0 | 0 | 1 (1.5) |
| Median time to response, mo (IQR) | 2.8 (2.7-2.9) | 2.8 (2.7-3.8) | 3.6 (2.7-6.0) | 2.7 (2.6-2.8) | 2.8 (2.7-3.7) |
MALT, mucosa-associated lymphoid tissue.
These patients presented with both nodal and extranodal lesions; therefore, the study sites were unable to classify the MZL subtype.
Two patients were excluded from the efficacy analysis set because central review determined their diagnosis as diffuse large B-cell lymphoma.
95% CIs were calculated using 2-sided Clopper-Pearson methodology.
One patient was classified as having “nonprogressive disease” because of a missed PET scan at cycle 3 (CT scan showed stable disease).