Table 3.
Clinical studies with ofatumumab in untreated CLL patients
| Study | Phase | Treatment | n | ORR (%) | CR (%) | Median PFS | Median OS |
|---|---|---|---|---|---|---|---|
| Wierda et al33 | II | O-FC | 61 | NR | NR | ||
| Ofa at different schedule in group A | 31 pts group A | 77 | 32 | ||||
| Group B | 30 pts group B | 73 | 50 | ||||
| Hillmen et al37 | III | Ofa plus Clb vs Clb monotherapy | 447 | NR at 29 months | |||
| 221 | 82 | 12 | 22.4 months | ||||
| 226 | 69 | 1 | 13.1 months | ||||
| Shanafelt et al38 | II | PCO | 48 | 96 | 46 | NR | NR |
Abbreviations: CLL, chronic lymphocytic leukemia; ORR, overall response rate; CR, complete response; PFS, progression-free survival; OS, overall survival; Ofa, ofatumumab; O-FC, Ofa + fludarabine–cyclophosphamide; pts, patients; Clb, chlorambucil; PCO, pentostatin, cyclophosphamide, and ofatumumab; NR, not reached.