Genmab moves up timeline for ofatumumab data in DLBCL
Genmab A/S (CSE:GEN) gained DKK2.80 to DKK42 on Monday after announcing a change to a Phase III trial of ofatumumab in diffuse large B cell lymphoma that could move up the trial's primary data readout by a year. Genmab now expects data on the primary endpoint of progression-free survival (PFS) in early 2014, instead of early 2015. Regulatory submissions could occur as early as year end 2014.
The trial is comparing three cycles of ofatumumab or Rituxan rituximab in combination with a chemotherapy regimen in patients with relapsed or refractory DLBCL. Under the amended protocol, all patients will now receive DHAP (cytarabine/cisplatin/dexamethasone) chemotherapy. The original protocol allowed for additional chemotherapy options, including DVD (dexamethasone, doxorubicin liposomal, vincristine) chemotherapy. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), which has worldwide co-development and commercialization rights, markets the anti- CD20 mAb as Arzerra in the U.S. and EU to treat chronic lymphocytic leukemia (CLL). ...