GlaxoSmithKline announces positive CLL drug trial

Top-line results for a recent study into GlaxoSmithKline (GSK) and Genmab’s chronic lymphocytic leukaemia (CLL) treatment have been positive.

It has been revealed that the phase III pivotal study initiated to evaluate the benefits of the ofatumumab (HuMax-CD20) drug for patients suffering from CLL has met with satisfactory results at both the primary and secondary endpoint.

The study considered 154 patients – 138 of which with refractory CLL were evaluable – and concluded that 59 of these were refractory to both fludarabine and alemtuzumab.

In the remaining 79 cases, the patients were refractory to fludarabine and found to be inappropriate for treatment with alemtuzumab due to the size of their lymph node tumours.

Of the patients in the first group, an objective response rate of 51 per cent was found and 30 of these were considered partial responses. In the second group, the objective response rate was 44 per cent and included 34 partial and one complete response.

Commenting on the results, vice-president and medicine development leader for GSK, Kathy Rouan, said the results had proved to be positive for both the patients and the companies involved.

“GSK and Genmab are collaborating on a comprehensive development programme for CLL ? which we hope will make a significant contribution to the management of these haematologic malignancies,” she added.

Earlier this month, GSK announced the appointment of Dan Troy as senior vice president and general counsel to global pharmacy supply operations.