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Published on 28 April 2015

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Genmab announces Phase III study of Arzerra® met primary endpoint in patients with relapsed CLL

Genmab A/S announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra® (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed CLL (p=0.0036) compared to those given fludarabine and cyclophosphamide alone. The safety profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.

Genmab A/S announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra® (ofatumumab) plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed CLL (p=0.0036) compared to those given fludarabine and cyclophosphamide alone. The safety profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.

We are pleased with the positive top-line results in this pivotal study of ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL.  This outcome is good news for patients with CLL, a disease for which relapses are inevitable.  We look forward to sharing additional data from the study at an upcoming medical conference and to discussions with the regulatory authorities in collaboration with Novartis,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.

About CLL
CLL, the most commonly diagnosed adult leukaemia in Western countries, accounts for approximately 1 in 4 cases of leukemia. (1,2) Most CLL patients experience disease progression despite initial response to therapy and may require additional treatment. (3)

About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomised, Phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomised 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.

The primary endpoint of the study was PFS, which was assessed by an Independent Review Committee (IRC) according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines. (4) Secondary endpoints included overall response rate, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments and quality of life.

Ofatumumab is not approved for this indication and Novartis will further analyse the data from the COMPLEMENT 2 study and plans to share the results with regulatory agencies to evaluate the potential for future regulatory filings.

About Arzerra
Arzerra (ofatumumab) is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukaemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. Arzerra is also approved for first-line use in Russia, Iceland, Norway, Luxembourg and Brazil.

In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Arzerra is marketed under a co-development and collaboration agreement between Genmab and Novartis, as successor in interest to GSK.



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