LLC essais clinique Azerra ofatumumab mai 2014

mai 2014
L'essai clinique pour une population "refractory" n'a pas montré d'amélioration significative par rapport au traitement de référence.

The Phase III study of ofatumumab (Arzerra(tm)) versus physicians' choice in patients with bulky fludarabine-refractory chronic lymphocytic leukaemia (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.

"Although ofatumumab performed broadly in-line with previous data, today's result is disappointing. Based on this result, we do not anticipate applying for a label expansion for ofatumumab in this specific refractory CLL population," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab