Arzerra fails ORCHARRD Phase III study for B Cell Lymphoma - GSK
GlaxoSmithKline plc and Genmab A/S announced that the Phase III study (ORCHARRD) of ofatumumab (Arzerra) plus chemotherapy versus rituximab plus chemotherapy to treat relapsed or refractory diffuse large B-cell Lymphoma (DLBCL) did not meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms. There were no differences in adverse events (AEs) leading to treatment discontinuation, Grade >3 AEs, severe adverse events (SAEs), or fatal SAEs between the treatment arms. However, there were more dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm, which require further analysis.
GSK said it is now unlikely that ofatumumab will be filed for this indication.
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