Table II.
Efficacy results.
| ORR, % (95% CI)* | Median PFS, month (95% CI)† | Survival, % ‡ | |
|---|---|---|---|
| FL (n = 39) | 49 (32·4, 65·2) | 20 (11·2, 29·7) | 86 |
| FLIPI low risk (n = 16) | 44 (19·8, 70·1) | 20 (8·5, 29·9) | 94 |
| FLIPI intermediate risk (n = 15) | 53 (26·6, 78·7) | 20 (7·5, N.E.) | 87 |
| FLIPI high risk (n = 8) | 50 (15·7, 84·3) | 12 (2·0, 30·1) | 75 |
| Indolent B-NHL (non-FL) § (n = 7) | 43 (9·9, 81·6) | 10 (4·1, N.E.) | 86 |
| MCL (n = 4) | 0 (0·0, 60·2) | N.E. | 50 |
| All FAS population (n = 50) | 44 (30·0, 58·7) | 18 (10·4, 25·8) | 84 |
| All ITT population (n = 56) | N.A. | N.A. | 81 |
ORR, overall response rate; CI, confidence interval; PFS, progression-free survival; FL, follicular lymphoma; FLIPI, Follicular Lymphoma International Prognostic Index; B-NHL, B-cell non-Hodgkin lymphoma; MCL, mantle cell lymphoma; FAS, full analysis set; ITT, intention to treat; N.E., not estimable; N.A., not applicable.
ORR was analysed by the data 1 year after the last patient enrolled.
Median PFS was analysed by the data 2 years after the last patient enrolled.
Survival rate was analysed at the data 2 years after the last patient enrolled.
Indolent B-NHL (non-FL) included four patients with extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type, two patients with small B-cell lymphoma not otherwise specified, and one patient with small lymphocytic lymphoma.