Download genmab`s humax-cd20 shows favorable clinical

Genmab A/S
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1253 Copenhagen K
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CVR no. 2102 3884
Contact:
Rachel Gravesen
VP IR&PR
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M: +45 25 40 30 01
E: [email protected]
GENMAB’S HUMAX-CD20 SHOWS FAVORABLE CLINICAL
RESPONSES IN NHL
Tumor Response Data in 300 and 500 mg Dose Groups
Summary: Genmab’s HuMax-CD20 shows a 55% response rate in a Phase I/II study for
patients with Non-Hodgkin’s Lymphoma in the lower dose groups of 300 and 500 mg
reported on at ASH.
Copenhagen, Denmark; December 4, 2004 – Genmab A/S (CSE: GEN) announced
today that 55% of patients (6 of 11) with relapsed or refractory follicular Non-Hodgkin’s
Lymphoma (NHL) treated with HuMax™-CD20 achieved a clinical response in the
Phase I/II study, including two complete responses and one unconfirmed complete
response for a 27% complete response rate. These responses were observed in 11
evaluable patients among the first 15 of the 40 patients included in this study at the week
11 evaluation point.
Patients in the 300 and 500 mg dose groups were assessed for clinical response at week
11, 8 weeks after their fourth and final dose of HuMax-CD20 and data was available for
two patients at week 19. In the 300 mg dose group, 57%, four of seven patients, achieved
a clinical response including two complete responses and two partial responses. One
patient maintained the complete response at week 19. One patient with a partial response
at week 11 achieved an unconfirmed complete response at week 19. In the 500 mg dose
group, two of four patients achieved a clinical response, one patient achieved a partial
response and one achieved an unconfirmed complete response. Confirmation of one
complete response by bone marrow biopsy is pending. All computerized tomography
(CT) images are evaluated centrally by an independent radiologist.
The 300 mg, 500 mg and 700 mg dose levels caused profound depletion of B-cells, which
are responsible for the growth of tumors in NHL patients.
No dose limiting toxicity has been reported with administration of HuMax-CD20 up to a
dose of 1000 mg per week. Six grade 3 adverse events considered related to HuMaxCD20 were reported in five patients. Four patients were reported as having hypotension,
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GENMAB’S HUMAX-CD20 SHOWS FAVORABLE CLINICAL
RESPONSES IN NHL
dysponea and pruritus. In addition, one patient in the 500 mg group was withdrawn
during the first infusion due to grade 3 dyspnoea and laryngeal edema due to cytokine
release considered related to the administration of HuMax-CD20. Twenty-five patients
reported predominantly brief grade 1 and 2 adverse events with onset on infusion days
consisting of symptoms of cytokine release such as pruritius, dyspnoea, rigors/chills,
nausea, hypotension, urticaria, fatigue, fever and rash.
“The significant responses of NHL patients in this study are very encouraging and we are
pleased to see that HuMax-CD20 seems to have a very good safety profile,” said Lisa N.
Drakeman, Ph.D., Chief Executive Officer of Genmab.
The data is being presented today at the 46th American Society of Hematology (ASH)
Annual Meeting and Exposition in San Diego, California by Anton Hagenbeek, Professor
of Hematology at the University Medical Center Utrecht. The poster can also been seen
at www.genmab.com
About the trial
In the Phase I/II dose escalation trial, 40 patients divided into four dose cohorts received
intravenous infusions of HuMax-CD20 at doses of 300, 500, 700, or 1000 mg once
weekly for four weeks and will be followed for 12 months. Forty patients have been
assessed for dose-limiting toxicities and 27 patients for safety in the study thus far and
results for all patients will be presented at a later date. The primary endpoint of the study
is clinical response at week 19 according to the Cheson criteria.
Cheson criteria
The Cheson criteria were developed by the National Cancer Institute and the international
pharmaceutical industry to provide a guideline for assessing clinical response in NHL.
According to the criteria, a complete response is obtained when there is a complete
disappearance of all detectable clinical and radiographic evidence of disease and disease
related symptoms, all lymph nodes have returned to normal size, the spleen has regressed
in size, and the bone marrow is cleared of lymphoma. An unconfirmed clinical response
is obtained when a patient shows complete disappearance of the disease and the spleen
regresses in size, but lymph nodes have regressed by more than 75% and the bone
marrow is indeterminate. For a partial response, there must be a 50% decrease in size of
the six largest dominant lymph nodes, no increase in size of the other nodes, liver or
spleen, splenic, hepatic nodules must regress by at least 50% and there must be no new
disease sites.
Conference Call
A conference call will be held to discuss this news on Monday, December 6 at
4:00 pm CET
3:00 pm GMT
10:00 am EST
The conference call will be held in English.
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RESPONSES IN NHL
The dial in numbers are as follows:
+1 800 946 0782 (in the US) and ask for the Genmab conference call
+1 719 457 2657 (outside the US) and ask for the Genmab conference call
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™ platform for the rapid creation and
development of human antibodies to virtually any disease target. Genmab is
headquartered in Copenhagen, Denmark, and has operations in Utrecht, The Netherlands,
and Princeton, New Jersey in the US. For more information about Genmab, visit
www.genmab.com.
Except for the historical information presented herein, matters discussed in this press
release are forward looking statements that are subject to certain risks and uncertainties
that could cause actual results to differ materially from any future results, performance
or achievements expressed or implied by such statements, e.g. unforeseen exchange rate
and interest rate fluctuations, delayed or unsuccessful development projects.
Statements that are not historical facts, including statements preceded by, followed by, or
that include the words “believes”; “anticipates”; “plans”; “expects”; “estimates”; or
similar statements are forward-looking statements. Genmab is not under an obligation to
up-date 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.
UltiMAb™ is a trademark of Medarex, Inc.
HuMax™ is a trademark of Genmab A/S
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