Table 1.
Clinical studies of single-agent ofatumumab in relapsed/refractory CLL
| Study | Phase | Treatment | n | ORR (%) | CR (%) | Median PFS | Median OS | |
|---|---|---|---|---|---|---|---|---|
| Coiffier et al1 | I/II | Ofa | 27 (cohort C) | 48 | 0 | 106 days | ND | |
| Wierda et al3 | II | Ofa in FA-ref | 138 | 59 | 58 | 0 | 5.7 months | 13.7 months |
| Ofa in BF-ref | 79 | 47 | 1 | 5.9 months | 15.4 months | |||
| Moreno et al22 | IV | Observational study | 103 | 22 | 3 | 5 months | 11 months | |
| Byrd et al23 | III | Ibrutinib vs Ofa | 391 | 43 vs 4 | 0 vs 0 | Ibrutinib NR (88% at 6 months) vs 8.1 months’ Ofa | Both groups NR; at 12 months, 90% vs 81% | |
Abbreviations: CLL, chronic lymphocytic leukemia; ORR, overall response rate; CR, complete response; PFS, progression-free survival; OS, overall survival; Ofa, ofatumumab; FA-ref, fludarabine- and alemtuzumab-refractory; BF-ref, fludarabine-refractory (with bulky [>5 cm] lymphadenopathy); ND, no data; NR, not reached.