Efficacy and safety of ofatumumab and bendamustine followed by ofatumumab maintenance in patients with relapsed indolent non-Hodgkin lymphoma after prior rituximab

Abstract

In indolent non-Hodgkin’s lymphoma (iNHL), patients treated with rituximab, alone or in combination with various chemotherapeutic agents eventually relapse. This study evaluated the combination of ofatumumab and bendamustine, followed by maintenance ofatumumab in patients with relapsed iNHL with prior sensitivity to rituximab. Among the 49 patients enrolled, 24.5% achieved a complete response (CR) and 42.9% achieved a partial response (PR), with an overall response rate of 67.3% at the end of the induction therapy. Additionally, six patients with PR during induction phase achieved CR during the maintenance phase. Treatment-related adverse event was observed in 95.9% patients. The most common hematologic and biochemical abnormalities were decrease in lymphocytes (85.7%) and increase in glucose (91.8%), respectively. Overall, 42.9% progressed and 14.3% died during the study. Thus, ofatumumab in combination with bendamustine, followed by ofatumumab maintenance, was effective in the treatment of patients with iNHL with a manageable safety profile (NCT01294579).

Keywords:

• Indolent non-Hodgkin lymphoma
• ofatumumab maintenance
• bendamustine
• clinical trial

Acknowledgments

We thank the patients and their families, investigators, and staff from all the participating sites. We thank Amrita Dutta, PhD, of Novartis Healthcare Pvt. Ltd., for providing medical editorial assistance with this manuscript.

Authors’ contributions

R.M. L., M.S., E. K., M. M., D. R., J. S., T.E.B enrolled patients for the study. X.F., was responsible for the statistical analysis. M.C. was responsible for the supervision of the study. R. F. provided medical supervision for the study and contributed to the analysis and interpretation of the data. All authors contributed to the review of the manuscript.

Disclosure statement

J.S. reports receiving personal fees from AstraZeneca, AbbVie, Acerta, Genentech, Pharmacyclics, Sunesis, and TG Therapeutics. T.E.B reports receiving personal fees for speaker’s bureau from AbbVie and served on advisory boards in Celgene and Juno Pharmaceuticals. R.F.C is an employee of Novartis. M.C and X.F. were former employees of Novartis. R.M.L., R.D, and M.M. have no conflicts to disclose.

Data availability statement

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Additional information

Funding

This work was supported by research funding from Novartis Pharma AG, Basel, Switzerland.