Genmab and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab Chronic Lymphocytic Leukemia Piv...( Summary: Phase III Pivotal Study o...),Health

Summary: Phase III Pivotal Study of Ofatumumab in Refractory CLL Meets

Primary Endpoint

COPENHAGEN, July 31 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) and GlaxoSmithKline (LSE and NYSE: GSK) announced today positive top-line results from an interim analysis of the Phase III pivotal study evaluating ofatumumab (HuMax-CD20(R)) to treat two groups of chronic lymphocytic leukemia (CLL) patients with high unmet medical need. At the interim analysis, the study met the primary endpoint in both populations and the results from the secondary endpoints also support the primary endpoint.

The activity of ofatumumab was evaluated in 154 patients in this interim analysis of whom 138 patients with refractory CLL were evaluable. About half of the patients (59) in the study were refractory to both fludarabine and alemtuzumab. The analysis also included a second group (79) who were refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes. An objective response rate of 51% (p<0.0001) consisting of 30 partial responses (PR) was achieved in the group of patients refractory to fludarabine and alemtuzumab. In the fludarabine refractory, alemtuzumab inappropriate patient group, an objective response rate of 44% (p<0.0001) was achieved, including 1 complete response (CR), and 34 PR. Achievement of the reported objective response rates are based on evaluations by an independent committee and are subject to review and confirmation by the regulatory authorities.

Ofatumumab was generally well tolerated by CLL patients in the study. The most frequently reported adverse events (those that occurred at a greater than 15% frequency) were: pyrexia, diarrhea, fatigue, cough, neutropenia, anemia and pneumonia. There were no unexpected safety findings. None of the 14 patients tested for human anti-human antibodies (HAHA) demonstrated their presence at 12 months.

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