GlaxoSmithKline (GSK) and Genmab have obtained US Food and Drug Administration (FDA) approval for Arzerra (ofatumumab) as first-line treatment in combination with chlorambucil for patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
FDA approval (Supplemental Biologic License Application) is based on the Phase III study (COMPLEMENT 1) results that showed statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and oral chemotherapeutic agent chlorambucil compared with patients who received chlorambucil alone.
COMPLEMENT 1 is a randomised, open-label, pivotal study that evaluated ofatumumab in combination with chlorambucil versus chlorambucil alone in 447 CLL patients who were previously untreated and for whom fludarabine-based therapy was considered inappropriate by study investigators.
Among the 447 patients (median age: 69) included in the study, the majority of patients (72%) had two or more comorbidities.
Primary objective efficacy of the parallel-arm Phase III study was progression-free survival, while the secondary efficacy endpoints included overall response, complete response, and duration of response.
With the exception of neutropaenia and leukopaenia, the overall rate of non-infusion-related Grade 3 or greater reactions with ofatumumab in combination with chlorambucil was similar to chlorambucil alone.
Genmab CEO Dr Jan van de Winkel noted that Arzerra has been shown to provide clinical benefit and will now be available in the first-line setting.
"Arzerra, the first approved therapeutic created by Genmab and developed in collaboration with GSK, is the only therapeutic CD20 antibody approved in combination with chlorambucil for first-line CLL and as a monotherapy for CLL refractory to fludarabine and alemtuzumab," Dr Winkel said.
The most common serious adverse reactions with Arzerra include infusion reactions, hepatitis B virus reactivation, hepatitis B virus infection, progressive multifocal leukoencephalopathy, tumour lysis syndrome, cytopaenias.
Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK. Arzerra is also indicated as monotherapy for the treatment of patients with chronic lymphocytic leukaemia refractory to fludarabine and alemtuzumab.
Image: GlaxoSmithKline headquaters in Brentford, London, UK. Photo: courtesy of Flickr upload bot.