GSK and Genmab’s ORCHARRD trial of lymphoma treatment fails to meet primary endpoint

19th May 2014 (Last Updated May 19th, 2014 18:30)

UK-based GlaxoSmithKline and Danish biotech firm Genmab have reported results from a Phase III trial (ORCHARRD) of ofatumumab (Arzerra) plus chemotherapy versus rituximab plus chemotherapy to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Diffuse large B cell lymphoma

UK-based GlaxoSmithKline and Danish biotech firm Genmab have reported results from a Phase III trial (ORCHARRD) of ofatumumab (Arzerra) plus chemotherapy versus rituximab plus chemotherapy to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The trial did not meet its primary endpoint as there was no statistically significant difference in progression free survival (PFS) between the treatment arms.

According to the firms, 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.

The results show 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.

GlaxoSmithKline head of oncology R&D Rafael Amado said the company is disappointed that the ORCHARRD trial did not meet its primary endpoint.

"We will further analyse these results to better understand the findings and how they add to our collective knowledge of this disease," Amado said.

"Based on today's results, we are unlikely to move forward with a regulatory filing."

Ofatumumab is being jointly developed by Genmab and GSK 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 is expected to provide further clarity on the 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 ORCHARRD Phase III 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.

In the trial, patients were randomised 1:1 to receive three cycles of either ofatumumab or rituximab in combination with DHAP (dexamethasone, cytarabine and cisplatin) salvage chemotherapy.

Following the third treatment cycle, patients who obtained a complete or partial response received high dose chemotherapy followed by an autologous stem cell transplant (ASCT).


Image: Micrograph of a diffuse large B cell lymphoma, abbreviated DLBCL. Photo: courtesy of Nephron.