Copenhagen, Denmark; July 31, 2008 - Genmab A/S (OMX: GEN)
and GlaxoSmithKline (LSE and NYSE: GSK) announced today positive top-line
results from an interim analysis of the Phase III pivotal study evaluating
ofatumumab (HuMax-CD20®) to treat two groups of chronic lymphocytic
leukemia (CLL) patients with high unmet medical need. At the interim
analysis, the study met the primary endpoint in both populations and the
results from the secondary endpoints also support the primary endpoint.
The activity of ofatumumab was evaluated in 154 patients in this interim
analysis of whom 138 patients with refractory CLL were evaluable. About
half of the patients (59) in the study were refractory to both fludarabine
and alemtuzumab. The analysis also included a second group (79) who were
refractory to fludarabine and considered inappropriate candidates for
alemtuzumab due to bulky tumor in their lymph nodes. An objective response
rate of 51% (p<0.0001) consisting of 30 partial responses (PR) was
achieved in the group of patients refractory to fludarabine and
alemtuzumab. In the fludarabine refractory, alemtuzumab inappropriate
patient group, an objective response rate of 44% (p<0.0001) was
achieved, including 1 complete response (CR), and 34 PR. Achievement of the
reported objective response rates are based on evaluations by an
independent committee and are subject to review and confirmation by the
regulatory authorities.
Ofatumumab was generally well tolerated by CLL patients in the study. The
most frequently reported adverse events (those that occurred at a greater
than 15% frequency) were: pyrexia, diarrhea, fatigue, cough, neutropenia,
anemia and pneumonia. There were no unexpected safety findings. None of the
14 patients tested for human anti-human antibodies (HAHA) demonstrated
their presence at 12 months.
A pre-BLA (Biologics License Application) meeting has been requested with
the FDA during which these data will be discussed with the potential of a
2008 BLA filing. There is also the potential to submit to the EU regulatory
authorities in this time frame. The full data will be submitted for
presentation to an academic meeting in due course.
"We are thrilled to report a positive outcome for the CLL patients in
this trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of
Genmab. "This also represents a significant achievement for Genmab as
we now move toward filing of the first marketing applications for a Genmab
antibody and we look forward to working with GSK on the submissions."
"These very encouraging results suggest that ofatumumab has the
potential to provide benefits to CLL patients with very refractory disease
and limited treatment options," said Kathy Rouan, Vice President and
Medicine Development Leader at GSK. "GSK and Genmab are collaborating
on a comprehensive development program for CLL as well as non-Hodgkin's
lymphoma (NHL), which we hope will make a significant contribution to the
management of these haematologic malignancies for both patients and their
physicians."
Ofatumumab is an investigational new generation fully human monoclonal
antibody that uniquely targets the small loop epitope (specific antibody
binding site) of the CD20 molecule on B cells. Ofatumumab is being
developed to treat chronic lymphocytic leukemia, follicular
non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid
arthritis and relapsing remitting Multiple Sclerosis under a co-development
and commercialization agreement between Genmab and GlaxoSmithKline. It is
not yet approved in any country.
About the trial
The study includes CLL patients who are refractory to both fludarabine and
alemtuzumab and patients who are refractory to fludarabine who are
considered inappropriate candidates for alemtuzumab due to bulky tumor in
their lymph nodes. All patients in the study receive 8 weekly infusions of
ofatumumab, followed by 4 monthly infusions of ofatumumab. Patients receive
300 mg of ofatumumab at the first infusion and 2000 mg of ofatumumab at
each subsequent infusion. Disease status is assessed every 4 weeks until
week 28 and then every 3 months until disease progression or month 24.
Patient recruitment is ongoing and a final analysis will be conducted on
the full study population, expected to be 100 patients in each group.
The primary endpoint of the study is objective response over a 24 week
period from start of treatment as assessed according to the National Cancer
Institute Working Group guidelines. The secondary endpoints are duration of
response, progression free survival, time to next CLL therapy, overall
survival and adverse events.
Conference Call
Genmab will hold a conference call to discuss these results today, July 31,
2008 at:
6:00 pm CEST
5:00 pm BST
12:00 pm EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1 888 740 6137 (in the US) and ask for the Genmab conference call
+1 913 312 1480 (outside the US) and ask for the Genmab conference call
To listen to a live webcast of the call please visit www.genmab.com.
About GlaxoSmithKline
One of the world's leading research-based pharmaceutical and healthcare
companies - is committed to improving the quality of human life by enabling
people to do more, feel better and live longer.
GlaxoSmithKline Cautionary statement regarding forward-looking
statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including those made
in this announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Factors that may
affect GSK' s operations are described under 'Risk Factors' in
the 'Business Review' in the company' s Annual Report on Form
20-F for 2007.