Phase III, randomized study of ofatumumab versus physicians’ choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia

Abstract

We report results of a randomized, phase III study of ofatumumab versus physicians’ choice treatment in patients with bulky fludarabine-refractory chronic lymphocytic leukemia and explore extended versus standard-length ofatumumab treatment. Patients (79 ofatumumab, 43 physicians’ choice) completed a median 6 (ofatumumab) or 3 (physicians’ choice) months’ therapy. Ofatumumab-treated patients with stable disease or better were randomized (2:1) to 6 months’ extended ofatumumab treatment or observation. Although the study did not meet the primary endpoint of progression-free survival (PFS) by independent review committee (ofatumumab: 5.4 months, physicians’ choice: 3.6 months; p = 0.27), median PFS by investigators was significantly longer for ofatumumab versus physicians’ choice (7.0 versus 4.5 months; p = 0.003) as was time to next therapy (median 11.5 versus 6.5 months; p = 0.0004). PFS and time to next therapy were significantly longer with ofatumumab extended treatment than observation (p = 0.026 and p = 0.002, respectively; n = 37). The adverse-event profile of long-term ofatumumab administration showed no unexpected findings (Clinicaltrials.gov identifier: NCT01313689).

Keywords:

• Anti-CD20 monoclonal antibody
• chronic lymphocytic leukemia
• extended-length therapy
• ofatumumab
• phase III clinical trial

Acknowledgements

The authors would like to thank the patients and the investigators in the OMB114242 study for their participation.

Editorial assistance and graphics were provided by PharmaWrite, LLC, in Princeton, NJ, USA, and Articulate Science, London, UK and were funded by GlaxoSmithKline and Novartis Pharmaceuticals Corporation, respectively.

The study was cosponsored by Genmab A/S and GlaxoSmithKline.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article at http://dx.doi.org/10.3109/10428194.2015.1122783.