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news.UK-based GlaxoSmithKline and Denmark-based biotech company Genmab have reported results from a Phase III trial (ORCHARRD) of ofatumumab (Arzerra) plus chemotherapy versus rituximab plus chemotherapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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The ORCHARRD trial failed to meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms.
GSK said that 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.
Results demonstrate that there were more dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab plus chemotherapy arm, which needs further analysis.
Genmab and GSK are jointly developing ofatumumab under a co-development and collaboration agreement.
Genmab chief executive officer Jan van de Winkel said the company plans to submit detailed data from the ofatumumab ORCHARRD trial in DLBCL for presentation at a medical conference later this year, which we hope will provide further clarity on today’s headline results.
"Based on today’s results we are unlikely to move forward with a regulatory filing," Winkel said.
DLBCL is the most common form of non-Hodgkin lymphoma (NHL) and is a fast-growing lymphoma or cancer of the B-cells.
The trial included 447 patients who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with a chemotherapy regimen containing anthracycline or anthracenedione.
Patients were randomized 1:1 to receive three cycles of either ofatumumab or rituximab in combination with DHAP (dexamethasone, cytarabine and cisplatin) salvage chemotherapy.