GSK and Genmab reveal disappointing Ph III data with ofatumumab + chemo in B-cell lymphoma

UK Pharma major GlaxoSmithKline (LSE: GSK) and Denmark’s Genmab (OMX: GEN) revealed yesterday that the Phase III ORCHARRD study of ofatumumab 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 (trade name Arzerra), plus chemotherapy arm, which require further analysis.

“We are disappointed that the ORCHARRD study did not meet its primary endpoint. We will further analyze these results to better understand the findings and how they add to our collective knowledge of this disease,” said Rafael Amado, head of oncology R&D at GSK.

On current results, regulatory filing in DLBCL “unlikely,” says Genmab

“We plan to submit detailed data from the ofatumumab ORCHARRD study 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,” said Jan van de Winkel, chief executive of Genmab.

This pivotal Phase III randomized study 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, and were eligible for autologous stem cell transplant (ASCT). Patients in the study were randomized 1:1 to receive three cycles of either ofatumumab or rituximab in combination with DHAP (dexamethasone, cytarabine and cisplatin) salvage chemotherapy. After the third treatment cycle, patients who obtained a complete or partial response received high dose chemotherapy followed by ASCT. The primary endpoint of the study was progression free survival.