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Arzerra fails to meet primary endpoint in CLL

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Results from a phase 3 trial have found that ofatumumab did not meet its primary endpoint of PFS for the treatment of chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab, manufacturers GlaxoSmithKline and Genmab reported.

“Although ofatumumab performed broadly in-line with previous data, today’s result is disappointing,” Jan van de Winkel, PhD, chief executive officer of Genmab, said in a press release. “Based on this result, we do not anticipate applying for a label expansion for ofatumumab in this specific refractory CLL population.”

In the phase 3, open-label study – OMB114242 – 122 patients with bulky fludarabine-refractory CLL were randomized 2:1 to receive either ofatumumab (Arzerra, GlaxoSmithKline) or physicians’ choice. Patients randomized to ofatumumab received an initial dose of 300 mg, followed one week later by 2,000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2,000 mg every 4 weeks for a total treatment duration of 6 to 12 months. Patients in the physicians’ choice group received a treatment regimen selected by a physician for up to six months.

The primary endpoint of the study was PFS as adjudicated by the Independent Review Committee. Secondary objectives are to evaluate response, OS, safety, tolerability and health-related quality of life of subjects treated with ofatumumab vs. physicians’ choice of treatment.

According to study results, the median PFS was 5.36 months for ofatumumab and 3.61 months for physicians’ choice (HR 0.79, P=0.267). The full analysis of safety and efficacy data is currently underway and will be completed in the coming months.

“It was our priority to share this result with the scientific community as soon it became available. We will now work to further analyze the data and to better understand the totality of the efficacy and safety findings,” Rafael Amado, MD, head of Oncology R&D at GlaxoSmithKline said. “We are very grateful to the CLL patients who participated in this trial.”