Genmab Announces Top-Line Phase Ii Results for Ofatumumab Combined With Chemotherapy in Second Line Aggressive Lymphoma
- Overall response rate of 61% in patients with
relapsed/refractory aggressive lymphoma
- No unexpected safety findings
- Data to be submitted for presentation at ASH
Copenhagen, Denmark; August 5, 2011 – Genmab A/S (OMX: GEN) announced today top-line results from a Phase II study of ofatumumab in combination with salvage chemotherapy to treat relapsed or refractory aggressive lymphoma, including Diffuse Large B-Cell Lymphoma (DLBCL).
A total of 61 patients with aggressive lymphoma, who had persistent or progressive disease after first-line treatment with rituximab combined with chemotherapy, were treated in the study. The overall response rate (ORR) was 61%. There were no unexpected safety findings. The most common grade 3 or higher adverse events were thrombocytopenia (59% of pts), anemia (36%), neutropenia (26%), lymphopenia (23%), leukopenia (18%), febrile neutropenia (13%) and hypokalemia (13%).
These data will be submitted for presentation at the 2011 Annual Meeting of the American Society of Hematology (ASH) in San Diego, US this December.
About the study
Patients in the study had previously received first line treatment with rituximab combined with standard chemotherapy. Patients received three cycles of ofatumumab in combination with ICE or DHAP salvage chemotherapy, which is used when cancer recurs or does not respond to first line treatment. The primary objective of the study was to evaluate the overall response rate of patients to ofatumumab in combination with ICE or DHAP chemotherapy according to criteria recognized by regulatory authorities known as the Revised Response Criteria for Malignant Lymphoma.
About Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma is a cancer of B-lymphocytes. DLBCL represents 30% of non-Hodgkin’s lymphomas in adults and is the most common lymphoid malignancy in the western world. Relapsed DLBCL occurs when the cancer returns after a period of improvement. Refractory DLBCL occurs when the cancer is resistant to or does not respond to initial treatment.
Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is not approved in any country for treatment of relapsed or refractory DLBCL. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
In the United States, ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. The effectiveness of ofatumumab is based on the demonstration of durable objective responses. No data demonstrate an improvement in disease-related symptoms or increased survival.
Ofatumumab can cause serious infusion reactions, prolonged and severe cytopenias, Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, and Hepatitis B infection and reactivation.
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, Arzerra® (ofatumumab), was approved to treat chronic lymphocytic leukemia that is 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 & Communication
T: +45 33 44 77 20; M: +45 25 12 62 60; E: firstname.lastname@example.org
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 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 Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; HuMax-EGFr™; HuMax-IL8™; HuMax-TAC™; HuMax-CD38™; HuMax-TF™; HuMax-Her2™; HuMax-cMet™, HuMax-CD74™, DuoBody™ and UniBody® are all trademarks of Genmab A/S. Arzerra® is a trademark of GlaxoSmithKline.
Company Announcement no. 26
CVR no. 2102 3884
1260 Copenhagen K
Posted: August 2011