FDA Grants Breakthrough Status to Johnson & Johnson, Genmab A/S Cancer Drug
Published: May 07, 2013
Copenhagen, Denmark; May 1, 2013 – Genmab A/S (OMX: GEN) announced today top-line results from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL). A total of 97 patients were treated in the study and 87% of patients completed the full course of six cycles of therapy. The study population comprised 44 patients with untreated CLL and 53 patients with relapsed CLL. In patients with untreated CLL the overall response rate (ORR) was 95%, with a complete response (CR) rate of 43%. The ORR in patients with relapsed CLL was 74%, with a CR rate of 11%. Treatment with ofatumumab and bendamustine was well tolerated by patients in the study . The most common adverse reactions (>20% of patients) were neutropenia, nausea, rash, pyrexia and thrombocytopenia.
"These data show encouraging clinical responses in patients treated with ofatumumab plus bendamustine, a commonly used chemotherapeutic agent, in both untreated and relapsed CLL. This is only the first set of key data we expect to report for ofatumumab over the next 15 months. Data from five pivotal studies are due during this time period, including results from a Phase III study of ofatumumab in front line CLL during the first half of 2013," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This Phase II study included patients who had untreated and relapsed CLL. Patients in the study were treated with a maximum of 6 cycles of study treatment. All subjects received 3 cycles of ofatumumab plus bendamustine and were eligible for additional treatment cycles dependent upon response to treatment. The primary objective of the study was to evaluate the investigator-assessed overall response rate according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCIWG) guidelines, in two populations: subjects with untreated CLL and subjects with relapsed CLL treated with ofatumumab plus bendamustine.
About chronic lymphocytic leukemia
CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013. At present, no cure is available.
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is marketed under the trade name ARZERRA(r) and is approved to treat chronic lymphocytic leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab in the US and EU as well as other territories. The approval was based on results from a pivotal study in this refractory patient population where 42% of patients responded to treatment with ARZERRA. These patients had a median duration of response of 6.5 months.
In the pivotal trial on which approval was based (total population n=154), the most common adverse reactions (>=10%, all grades) to ofatumumab were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnoea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia. A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced >=Grade 3 infections, of which 19 (12%) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%.
ARZERRA is not approved for the treatment of untreated CLL anywhere in the world.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (ARZERRA(r)), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: email@example.com
This Company Announcement 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 pre-clinical and clinical development of products, 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 risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com . Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
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Company Announcement no. 19
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