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Genmab Announces Top-Line Phase II Results For Ofatumumab Combined With Bendamustine In Untreated And Relapsed Chronic Lymphocytic Leukemia

Company Announcement

  • 95% overall response rate and 43% complete response rate in patients with previously untreated chronic lymphocytic leukemia
  • 74% overall response rate and 11% complete response rate in relapsed chronic lymphocytic leukemia
  • Treatment was well tolerated with 87% of patients completing the full treatment course

COPENHAGEN, Denmark, May 1, 2013 (GLOBE NEWSWIRE) -- Genmab A/S (Copenhagen:GEN) announced today top-line results from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).

A total of 97 patients were treated in the study and 87% of patients completed the full course of six cycles of therapy. The study population comprised 44 patients with untreated CLL and 53 patients with relapsed CLL. In patients with untreated CLL the overall response rate (ORR) was 95%, with a complete response (CR) rate of 43%.  The ORR in patients with relapsed CLL was 74%, with a CR rate of 11%.  Treatment with ofatumumab and bendamustine was well tolerated by patients in the study . The most common adverse reactions (>20% of patients) were neutropenia, nausea, rash, pyrexia and thrombocytopenia.

"These data show encouraging clinical responses in patients treated with ofatumumab plus bendamustine, a commonly used chemotherapeutic agent, in both untreated and relapsed CLL.  This is only the first set of key data we expect to report for ofatumumab over the next 15 months.  Data from five pivotal studies are due during this time period, including results from a  Phase III study of ofatumumab in front line CLL during the first half of 2013," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the study

This Phase II study included patients who had untreated and  relapsed CLL.  Patients in the study were treated with a maximum of 6 cycles of study treatment. All subjects received 3 cycles of ofatumumab plus  bendamustine and were eligible for additional treatment cycles dependent upon response to treatment.  The primary objective of the study was to evaluate the investigator-assessed overall response rate according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCIWG) guidelines, in two populations: subjects with untreated CLL and subjects with relapsed CLL treated with ofatumumab plus bendamustine.

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