Standard Versus Escalated Dose of Ofatumumab in Chemoimmunotherapy Regimen for CLL
Posted: Tuesday, July 13, 2021
For patients with chronic lymphocytic leukemia (CLL), chemoimmunotherapy consisting of cytotoxics and anti-CD20 monoclonal antibodies has been the standard treatment. However, the optimal dosing of common monoclonal antibodies, including rituximab, obinutuzumab, and ofatumumab, remains unknown. Results of a phase II randomized control trial, published in the British Journal of Haematology, reported that the use of dose-escalated ofatumumab-based chemotherapy may not improve outcomes in this patient population.
“However, these results do not preclude the existence of such dose response when CD20 monoclonal antibodies are combined with targeted agents, and further investigation of CD20 monoclonal antibody dose with targeted agents may be warranted,” Peter Hillmen, PhD, of the University of Leeds, United Kingdom, and colleagues concluded.
The research team randomly assigned 61 patients with relapsed CLL to receive ofatumumab at standard (n = 32) or high dose (n = 29) plus investigator’s choice of chemotherapy including fludarabine and cyclophosphamide or bendamustine. The investigators assessed complete remission or complete remission with incomplete blood cell count recovery as the primary endpoint to warrant further research into the dose schedules.
An intention-to-treat analysis revealed that seven patients (22%) who received the standard dose and seven patients (24%) who received escalated-dose schedules achieved complete remission or complete remission with incomplete blood cell count recovery. Both fell below the predefined efficacy threshold required to warrant further study.
The proportion of patients who achieved complete remission was similar in both older and younger patients, males and females, and those with shorter prior remissions (6–24 months) and longer remissions (more than 24 months). The overall and progression-free survival outcomes were also comparable to those in previous studies. Furthermore, the toxicity profiles were similar to previous reports for fludarabine and cyclophosphamide, bendamustine, and ofatumumab, and patients who received the escalated dose of ofatumumab did not report “excess infusional reactions.”
Disclosure: The study authors reported no conflicts of interest.
