GlaxoSmithKline and Genmab report positive data from CLL drug trial

GlaxoSmithKline and Genmab have announced that their drug ofatumumab has met its primary endpoint in a new efficacy trial for chronic lymphocytic leukaemia (CLL).

An independent data monitoring committee has issued interim analysis of the phase III study Prolong, showing that the maintenance therapy has reached the predefined significance level for efficacy among patients with relapsed CLL.

The committee did not identify any new safety signals and will continue to monitor patients for safety until all study participants complete therapy. Further analysis of the results remains ongoing and will be presented at future conferences.

Dr Rafael Amado, head of oncology research and development at GlaxoSmithKline, said: "We look forward to sharing the results of the interim analysis with regulatory agencies to evaluate the potential for future regulatory filings."

Ofatumumab is already approved under the brand name Arzerra for use in more than 50 countries as a monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

Last month, the drug was approved in Europe in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and are not eligible for fludarabine-based treatment.