Summary: Phase III Pivotal study did not fulfill a criterion for early stopping; Independent Data Monitoring Committee has recommended that the trial should continue to enroll patients. Copenhagen, Denmark; January 5, 2009 - Genmab A/S (OMX: GEN) announced today that the interim survival analysis of the Phase III pivotal study investigating zalutumumab (HuMax-EGFr(R)) in refractory head and neck cancer patients did not fulfill a criterion for early stopping after half the trial has been completed. An Independent Data Monitoring Committee (IDMC) has evaluated the interim results and concluded that the benefit-risk profile of zalutumumab is acceptable. The IDMC recommended that the trial should continue to enroll up to a maximum of 273 patients and a final analysis performed. As of today, 212 patients have been randomized and the final analysis will take place once 231 deaths have occurred. "We are pleased that this study will continue and are optimistic that the full study results will show extended survival in patients with advanced head and neck cancer," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. About the trial The pivotal study will include a maximum of 273 patients with squamous cell carcinoma of the head and neck (SCCHN) who are refractory to or intolerant of standard platinum-based chemotherapy. Patients in the study will be randomized into two treatment groups: zalutumumab in combination with best supportive care or best supportive care alone. Patients treated with zalutumumab in combination with best supportive care will receive an initial dose of 8mg/kg of zalutumumab, followed by weekly infusions of a maintenance dose until disease progression. The maintenance dose will be adjusted as necessary until the patient develops a dose limiting skin rash, up to a maximum dose of 16 mg/kg of zalutumumab. Disease status will be assessed every 8 weeks by CT scan or MRI according to RECIST criteria until disease progression and patients will be followed for survival. The objective of the study is to evaluate the efficacy of zalutumumab in combination with best supportive care as compared to best supportive care alone in terms of overall survival. The primary endpoint in the study is overall survival from randomization until death. Conference Call Genmab will hold a conference call to discuss these results today, January 5, 2009 at: 6:00 pm CET 5:00 pm GMT 12:00 pm EST The conference call will be held in English. The dial in numbers are as follows: +1 877-856-1969 (in the US) and ask for the Genmab conference call +1 719-325-4814 (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 Genmab A/S Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit 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. For a further discussion of these risks, please refer to the section “Risk Management” in Genmab's Annual Report, which is available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this press release nor to confirm such statements in relation to actual results, unless required by law. Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S. Contact: Helle Husted, Sr. Director, Investor Relations, T: +45 33 44 77 30, M: +45 25 27 47 13, E: hth@genmab.com Stock Exchange Release no. 01/2009 ###
Genmab Announces Interim Results in Pivotal Study of Zalutumumab in Head and Neck Cancer
| Source: Genmab A/S