Table 4.
Clinical trials evaluating obinutuzumab (GA-101) in indolent lymphomas.
| Study | Number of patients (histotypes) | Population | Treatment schedule | ORR% (CR) | PFS (months) |
|---|---|---|---|---|---|
| Salles et al. [2012] | 21 (13 FL, 2 LPL, 1 SLL, 4 MCL, 1 DLBCL) | Rel/Ref | Obinutuzumab (50 to 2000 mg x9, q7) | 43 | |
| Salles et al. [2011] | 40 (34 FL, 6 iNFL) | Rel/Ref | Obinutuzumab (1600/800 versus 400/400 mg x9, q7) | 60 (20) versus 35 (7) | 11.8 versus 6 |
| Sehn et al. [2012] | 22 (10 FL, 2 SLL, 5 CLL, 1 MCL, 4 DLBCL) | Rel/Ref | Obinutuzumab (100 to 2000 mg x4 q7 + 8 q12) | 22 | |
| Sehn et al. [2011] | 175 (149 FL, 26 iNFL) | Rel/Ref | Obinutuzumab (1000 mg) versus Rituximab 375 mg/m2) x4, q7 | 43 versus 28 | |
| Radford et al. [2011] | 56 (FL) | Rel/Ref | [G-CHOP] versus [G-FC] (Obinutuzumab 1600/800 versus 400/400 mg) | 96.4 (39) versus 92.9 (50) |
FL, follicular lymphoma; SLL, small lymphocytic lymphoma; LPL, lymphoplasmacytic lymphoma; MCL, mantle-cell lymphoma; iNFL, indolent nonfollicular lymphoma; DLBCL, diffuse large B-cell lymphoma; CLL, chronic lymphocytic leukemia; Rel/Ref, relapsed/refractory; G, GA-101 (obinutuzumab); R, rituximab; ORR, overall response rate; CR, complete remission; PFS, progression-free survival