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.
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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.
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By GlobalDataGenmab 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.
