Genmab A/S (CSE:
GEN) announced today additional positive results in the HuMax-CD20(TM)
(ofatumumab) Phase I/II study to treat patients with relapsed or refractory
chronic lymphocytic leukemia (CLL). An objective response rate of 50% (13
of 26 evaluable patients) was observed in patients treated at the highest
dose level (2000 mg). This included one nodular partial remission (nPR)
confirmed by CT scan and one patient who qualified as nPR but had residual
lymphadenopathy revealed by CT.
Responders include one additional patient compared to previously
reported data.
The median time to disease progression in all patients treated at 2000
mg was approximately 16 weeks ranging from 15 to 23 weeks. In the patients
responding to HuMax-CD20 treatment, the median time to disease progression
was 23 weeks ranging from 20 – 31 weeks. The median time to next anti-CLL
treatment was 52 weeks. These survival endpoints correlated statistically
to the patients’ total exposure to HuMax-CD20 over time and to the
clearance of the antibody.
“The CLL patients in this study appear to have benefited from treatment
with HuMax-CD20. These data strongly support further development of HuMax-
CD20 in CLL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer at
Genmab.
These results are being presented at poster session #2842 on December
11 from 10:30AM to 7PM local time in Hall E1 West, board 71-III at the 48th
Annual American Society of Hematology Annual Meeting and Exposition in
Orlando, Florida.
About the study
The study is an open-label dose escalation trial that enrolled 33
patients who had failed previous therapy. The trial has three dose levels.
Three patients at the first dose level received an initial dose of 100 mg
followed by three weekly doses of 500 mg; at the second dose level three
patients received a dose of 300 mg followed by three weekly doses of 1,000
mg; and at the third level, 27 patients received an initial dose of 500 mg
followed by three weekly doses of 2,000 mg.
The total follow up period for this study is 12 months from treatment
start and the primary endpoint of the trial is objective response over the
period from screening to week 19. An objective response is one that lasts
at least 8 weeks by the NCI working group guidelines for CLL.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human
antibodies for the treatment of life-threatening and debilitating diseases.
Genmab has numerous products in development to treat cancer, infectious
disease, rheumatoid arthritis and other inflammatory conditions, and
intends to continue assembling a broad portfolio of new therapeutic
products. At present, Genmab has multiple partnerships to gain access to
disease targets and develop novel human antibodies including agreements
with Roche and Amgen. A broad alliance provides Genmab with access to
Medarex, Inc.’s array of proprietary technologies, including the UltiMAb(R)
platform for the rapid creation and development of human antibodies to
virtually any disease target. In addition, Genmab has developed
UniBody(TM), a new proprietary technology that creates a stable, smaller
antibody format. Genmab has operations in Copenhagen, Denmark, Utrecht, the
Netherlands, Princeton, New Jersey, US and Hertfordshire in the United
Kingdom. For more information about Genmab, visit genmab.
This press release 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 product discovery and development,
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. Genmab is not under an obligation to update statements
regarding the future following the publication of this release; nor to
confirm such statements in relation to actual results, unless this is
required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-
EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM),
HuMax-CD38(TM); and UniBody(TM) are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
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