Ofatumumab-Based Regimens Improve Survival in CLL


Combination therapies utilizing ofatumumab could improve outcomes for patients with chronic lymphocytic leukemia, according to an analysis published in the Annals of Hematology.

Image Credit: © Tatiana Shepeleva [www.stock.adobe.com]

Image Credit: © Tatiana Shepeleva [www.stock.adobe.com]

The use of ofatumumab-based regimens was associated with a benefit in progression-free survival (PFS) compared with non-ofatumumab regimens in patients with chronic lymphocytic leukemia.1

Findings come from a meta-analysis for which data were published in the Annals of Hematology and show that with the benefit in survival associated with ofatumumab in CLL, other combination regimens with ofatumumab should be evaluated to see if they can further improve patient outcomes.

“Our analysis showed the pooled efficacy for progression-free survival [PFS] was statistically significantly improved with ofatumumab-based treatments for chronic lymphocytic leukemia compared with other groups. Ofatumumab-based therapies for chronic lymphocytic leukemia patients could be improved by other combinational-based regimens,” Masoud Mohammadi, Department of Hematology and Medical Laboratory Sciences, faculty of Allied Medicine, Kerman University of Medical Sciences, Kerman, Iran, told Targeted OncologyTM.

Ofatumumab is a fully human anti-CD20 monoclonal antibody that was approved by the FDA in 2016 based on data from the phase 3 COMPLEMENT-2 study (NCT00824265). In the study, the addition of ofatumumab to chemotherapy elicited a median PFS of 28.9 months vs 18.8 months with fludarabine and cyclophosphamide alone (HR, 0.67; 95% CI, 0.51-0.88; P =.0032). With the triplet, the overall response rate was 84% vs 68% in the control arm (P =.0003). Complete response rates were 27% vs 7%, respectively.2

Though the therapeutic impact of ofatumumab on patients with CLL has been the subject of increasing clinical research, no studies in recent years have provided a pooled assessment of the treatment effect of ofatumumab vs non-ofatumumab regimens in this patient population.1

In a progression meta-analysis, investigators sought to evaluate the efficacy of ofatumumab-based treatment in patients with CLL through analyzing data from clinical studies from publications in PubMed, Web of Science and ClinicalTrials.gov. Articles were reviewed and searched which matched the specific keywords until January 2023.

A total of 338 records were identified from databases with 5 included in the study. The efficacy end points evaluated were progression-free survival (PFS) and overall survival (OS).

According to the pooled efficacy analysis, a significant difference in PFS was reported between ofatumumab-based therapy and non-ofatumumab therapy (hazard ratio (HR), 0.62; 95% CI, 0.52-0.74). There was also no significant difference in OS (HR, 0.86; 95% CI, 0.71-1.03) reported between these 2 therapies.

When compared with other groups, the pooled efficacy for PFS was statistically significant with improvements seen for ofatumumab-based treatments for patients with CLL. Additionally, no statistically significant improvement in the OS was observed among patients with CLL given ofatumumab.

These data highlight that ofatumumab-based therapies for CLL patients could be improved by other combinational-based regimens. Moving forward, Mohammadi notes there is a need to further evaluate ofatumumab in other regimens for this patient population.

“Future studies can consider other regimens in the treatment of chronic lymphocytic leukemia in order to provide a comparative aspect,” added Mohammadi.

  1. Ashoub MH, Naseri A, Mohammadi P, Mohammadi M. Ofatumumab regimens in chronic lymphocytic leukemia: a meta-analysis. Ann Hematol. 2023;102(6):1301-1306. doi:10.1007/s00277-023-05246-x
  2. Robak T, Warzocha K, Govind Babu K, et al. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial. Leuk Lymphoma. 2017;58(5):1084-1093. doi:10.1080/10428194.2016.1233536
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