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Genmab reports topline results in phase III study of Arzerra iniNHL did not meet primary endpoint.

NORDIC BUSINESS REPORT-May 25, 2018-Genmab reports topline results in phase III study of Arzerra iniNHL did not meet primary endpoint

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Biotechnology company Genmab A/S (CPH:GEN) reported on Thursday that topline results from the phase III study of Arzerra (ofatumumab) plus bendamustine did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, as compared to those given bendamustine alone.

Also, the safety profile observed in this study was consistent with that observed in other trials of ofatumumab and no new safety signals were observed.

According to the company, it is disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial. The full data will be submitted for publication at a future medical conference.

Also, the results from this phase III study do not impact any other ongoing studies with ofatumumab, the company clarified.

This III study is an open-label, two-arm, randomized, phase III study that included 346 patients with indolent B-cell non-Hodgkin's lymphoma who were unresponsive to rituximab or a rituximab-containing regimen. Patients in the study were randomised 1:1 to treatment with up to eight cycles of bendamustine given in combination with 12 doses of ofatumumab (1,000 mg) or up to eight cycles with bendamustine alone. The primary endpoint of the study was PFS.

Ofatumumab is not approved for the treatment of indolent non-Hodgkin's Lymphoma.

Arzerra is marketed under a collaboration agreement between Genmab and Novartis. A subcutaneous formulation of ofatumumab is also being investigated in two phase III clinical studies in relapsing multiple sclerosis.

Genmab is specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer. The company has two approved antibodies, DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukaemia indications.

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Publication:Nordic Business Report
Article Type:Report
Date:May 25, 2018
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