GSK and Genmab’s ofatumumab disappoints in Ph III CLL study

28 June 2014

UK pharma giant GlaxoSmithKline (LSE: GSK) and Danish partner Genmab (OMX: GEN) have revealed that the Phase III study of ofatumumab (Arzerra) versus physicians’ choice in patients with bulky fludarabine-refractory chronic lymphocytic leukemia (CLL) did not meet its primary endpoint of progression free survival (PFS).

The median PFS, as assessed by the Independent Review Committee, was 5.36 months for ofatumumab and 3.61 months for physicians’ choice (Hazard Ratio 0.79, p=0.267). The result reported on Friday is headline data; the full analysis of safety and efficacy data is underway and will be completed in the coming months.

This study (OMB114242) was conducted to meet the requirements from the European Commission for the conditional approval of ofatumumab for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. The current indications in the European Union or USA do not include bulky fludarabine-refractory CLL patients, the companies noted.

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