Company Announcement
- Arzerra now approved by U.S. FDA for use in combination with fludarabine and cyclophosphamide in relapsed
CLL
- Approval based on data from Phase III COMPLEMENT 2 study
COPENHAGEN, Denmark, Aug. 31, 2016 (GLOBE NEWSWIRE) -- Genmab A/S (Copenhagen:GEN) announced today that the U.S.
Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab
(Arzerra(r)) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic
lymphocytic leukemia (CLL). The application, which received Priority Review in May 2016, was submitted to the FDA by
Novartis under the ofatumumab collaboration between Novartis and Genmab.
Approval for this indication by the FDA is based on results from the Phase III COMPLEMENT 2 study that evaluated ofatumumab in
combination with FC versus FC alone in patients with relapsed CLL. Top-line results from COMPLEMENT 2 were reported in April
2015.
"This is the fourth CLL indication approved in the U.S. for Arzerra, and we are pleased to see the availability of this
treatment expand to a wider number of patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About CLL
CLL is the most commonly diagnosed adult leukemia in Western countries, and accounts for approximately 1 in 4 cases of
leukemia.1 Most CLL patients experience disease progression despite initial response to therapy and may require
additional treatment.2
About COMPLEMENT 2
COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III study, which included 365 patients in 18 countries
with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with
fludarabine and cyclophosphamide (FC) or up to six cycles with fludarabine and cyclophosphamide alone.
The primary endpoint of the study was progression free survival (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.3 The study met the primary endpoint with a median progression free
survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC
alone (HR =0.67, p=0.0032). 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. The safety
profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.
About Ofatumumab ( Arzerra(r))
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic
lymphocytic leukemia (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 and for extended treatment of patients who are in
complete or partial response after at least two lines of therapy for recurrent or progressive CLL. 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. 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.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis has rights to develop ofatumumab in
autoimmune indications, including multiple sclerosis.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated
antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, Arzerra(r)
(ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX(r) (daratumumab) for the treatment
of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma
indications and for non-Hodgkin's lymphoma. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody technologies - the DuoBody(r) platform for
generation of bispecific antibodies, and the HexaBody(r) platform which creates effector function enhanced antibodies. The
company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has
alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and
"plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any
future results or performance expressed or implied by such statements. The important factors that could cause our actual results or
performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products,
uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to
product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment
in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes
and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks,
please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com . Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results,
unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab(r); the Y-shaped Genmab logo(r);
Genmab in combination with the Y-shaped Genmab logo(tm); the DuoBody logo(r); the HexaBody logo(tm);
HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(r) and UniBody(r).
Arzerra(r) is a trademark of Novartis AG or its affiliates. DARZALEX(r) is a trademark of Janssen Biotech,
Inc.
References
1 GlobalData. EpiCast Report: Chronic Lymphocytic Leukemia Epidemiology Forecast to 2023. Published May 2014.
2 Veliz M, Pinilla-Ibarz J. Treatment of relapsed or refractory chronic lymphocytic leukemia. Cancer Control.
2012; 1:37-53.
3 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia:
a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996
guidelines. Blood 2008; 111: 5446-56.
Company Announcement no. 39
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
