Table 3.
Selected Trials of Obinituzumab and Other Agents
Trials | Phase | Dose* (mg) | Number | Treatment Arms | AE’s | Best Overall Response |
---|---|---|---|---|---|---|
Fisher K et. al. 63 (CLL14 Trial) | III | O: 1000 mg V: 20–400 mg |
13 | O+V | Neutropenia: 66.7% (G 3/4: 58%) IRRs: 75% (G 3/4: 8%) |
ORR: 100% CR: 58% MRD 92% |
Amaya-Chanaga CI et al. 59 | IB/II | O: 1000 mg I: 420 mg |
9 | O+I | Neutropenia: 33% (G 3/4: 22%) IRRs: 11% (G 3/4: 0) |
CR: 50% (N=1) PR:50% (N=1) |
Von Tresckow J et al. 64 (CLL2-BIG trial) | II | O: 1000 mg I: 420 mg |
66 | O+I | Neutropenia: 19% (G 3/4: 14%) IRRs: 33% (G 3/4: 2%) |
ORR: 100% CR: 46% PR: 54 % |
Cramer P. et al. 65 (CLL2-BAG Trial) | II | B: 70 mg/m2 O: 1000 mg V: 20–400 |
66 | B→O/V | Neutropenia: 11% IRRs: 9% |
ORR: 97% CR: 38% |
Jain N et al. 66 (iFCG Trial) |
II |
FC O: 1000 mg I: 420 mg |
23 | iFCO | Neutropenia (G 3/4): 48% | ORR: 100% CR: 39% |
Abbreviations: O/G, obinutuzumab; V, venetoclax; I, ibrutinib; B, bendamustine; FC, fludarabine/cyclophosphamide; CR, complete remission; PR, partial remission; ORR, objective response rate; MRD, minimal residual disease; IRRs, infusion-related reactions.