Genmab A/S Announces Data On All Evaluable Patients In HuMax(R)-CD20 NHL Phase I/II Study
COPENHAGEN, Denmark, Dec. 1 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) announced today additional positive results in the HuMax-CD20 Phase I/II study to treat patients with relapsed or refractory follicular non-Hodgkin's lymphoma (NHL).
Overall, there were 37 evaluable patients and objective response rates at each dose level in this safety study were 63% (300 mg), 33% (500 mg), 20% (700 mg) and 60% (1000 mg) for an overall response rate of 43%, according to the Cheson criteria. These response rates include 5 complete responses (CR), 2 complete responses unconfirmed (CRu) and 9 partial responses (PR). A CRu meets and exceeds the criteria for partial response.
Responders include one additional patient compared to the data previously reported in June.
The new responding patient had previously responded to rituximab. This increases the objective response rate in patients who previously responded to rituximab treatment to 64% (9 of 14 patients), including 3 CR, 1 CRu and 5 PR.
The median duration of response and median time to disease progression in responding patients have not yet been reached after 12 months of follow up. Of the 16 patients who responded to treatment, 12 have not progressed at the end of the follow up period.
HuMax-CD20 was well tolerated by the patients in the study. No dose limiting toxicities were reported and the maximum tolerated dose was not reached.
"We are particularly encouraged by the response rate in relapsed patients and look forward to the ongoing development of HuMax-CD20 in follicular lymphoma," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the Trial
The Phase I/II dose escalation trial was designed for 40 patients divided into 4 dose cohorts to receive intravenous infusions of HuMax-CD20 at doses of 300, 500, 700 or 1000 mg once weekly for 4 weeks and were followed for 12 months. Thirty-seven patients were evaluable. Patients in this study had relapsed or refractory follicular lymphoma and have previously received a median of 2 treatment regimens, including the possibility of rituximab.
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, Amgen and Serono. 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. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in the US. For more information about Genmab, visit http://www.genmab.com .
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 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.
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CONTACT: Helle Husted, Director, Investor Relations for Genmab A/S, +45 3344 77 30, or mobile, +45 25 27 47 13, or email@example.com
Web site: http://www.genmab.com//