Genmab Announces Update on Recruitment of Patients in ofatumumab CLL Pivotal Study
Wednesday November 28, 4:10 am ET
Summary: Genmab and GlaxoSmithKline Have Completed Recruitment of 66 CLL Patients Respectively to Both Study Groups in a Pivotal Study of ofatumumab
COPENHAGEN, Denmark, November 28 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today recruitment of 132 patients has been completed in a pivotal study of ofatumumab (HuMax-CD20®) for the treatment of refractory chronic lymphocytic leukemia (CLL). This cohort comprises 66 patients who are refractory to both fludarabine and alemtuzumab and 66 fludarabine refractory patients who are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes. An interim analysis will be conducted on this cohort when 24 week efficacy data are available. The study will remain open for recruitment in order to collect additional safety and efficacy data.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of b-cells. This epitope is different to the other anti-CD20 antibodies currently available or in development. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
"We look forward to seeing the study results of the interim analysis from both patient groups. It is our hope, due to the high unmet need amongst these patients, that registration may be possible in each indication, depending on the data generated and ongoing discussions with the regulatory authorities. Recruitment will continue to the trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the study
The study includes CLL patients who are refractory to both fludarabine and alemtuzumab and patients who are refractory to fludarabine who are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes. Each group will be analyzed separately and it is hoped that, registration of ofatumumab may be possible in each indication, depending on the data generated from this study and the ongoing discussions with the regulatory authorities.
All patients in the study will receive 8 weekly infusions of ofatumumab, followed by 4 monthly infusions of ofatumumab. Patients will receive 300 mg of ofatumumab at the first infusion and 2,000 mg of ofatumumab at each subsequent infusion. Disease status will be assessed every 4 weeks until week 28 and then every 3 months until disease progression or month 24. |
