Arzerra meets PFS endpoint as CLL maintenance therapy
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Genmab A/S (CSE:GEN; OTCBB:GMXAY) said an interim analysis by an independent DMC showed Arzerra ofatumumab as maintenance treatment in patients with relapsed chronic lymphocytic leukemia (CLL) responding to induction therapy met the primary endpoint of improving progression-free survival (PFS) vs. no further treatment (observation) in the Phase III PROLONG (OMB 112517) trial. The pre-defined threshold for significance on the endpoint was p<=0.001. GlaxoSmithKline said it plans to share the results with regulatory agencies to evaluate the potential for future regulatory applications, but could not be reached for details.
Arzerra is approved in the U.S. and EU to treat CLL refractory to fludarabine and alemtuzumab and as first-line treatment of CLL. GSK has worldwide co-development and commercialization rights to the human mAb against CD20 from Genmab, which was off DKK1.50 to DKK223.30 on Thursday. The news came after market close in Denmark. ...