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GSK and Genmab announce positive top-line results from pivotal trial of ARZERRA® (ofatumumab) combined with chlorambucil in previously untreated chronic lymphocytic leukaemia

GSK and Genmab announce that their Phase III study of ARZERRA® (ofatumumab) in combination with chlorambucil versus chlorambucil alone in patients with previously untreated chronic lymphocytic leukaemia (CLL) met its primary endpoint of progression free survival (PFS) as assessed by an independent review committee (IRC).

Issued: London UK

GlaxoSmithKline (GSK) plc and Genmab A/S (OMX: GEN) announced today that their Phase III study of ARZERRA® (ofatumumab) in combination with chlorambucil versus chlorambucil alone in patients with previously untreated chronic lymphocytic leukaemia (CLL) met its primary endpoint of progression free survival (PFS) as assessed by an independent review committee (IRC).

A total of 447 patients were enrolled in the study. A 9.3 month improvement in the time a patient lived without worsening of their disease (median PFS) was seen in patients randomised to ofatumumab and chlorambucil compared to patients randomised to chlorambucil alone (22.4 months vs 13.1 months; HR: 0.57; p<0.001).

There were no unexpected safety findings. The most common (=1%) serious adverse events as reported by the investigator within 60 days of last treatment were neutropenia [including febrile neutropenia] (5%), anaemia (4%), pneumonia (4%), and pyrexia (2%). Infusion reactions were mild to moderate in severity with 3% of infusion reactions reported as serious.

“As the aim of treating CLL, particularly in the frontline setting, is to maximise progression free survival while minimising side effects, we are therefore encouraged by these promising results.” said Dr. Kathy Rouan, Vice President BioPharmaceutical Development, GlaxoSmithKline. “We are planning regulatory submissions in the EU, US, and other regions in the coming months.”

“We are delighted with the positive results from this trial which we believe may lead to ofatumumab plus chlorambucil as an additional treatment option for the care of patients with CLL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to submitting the study results, including secondary endpoints, to the International Workshop on CLL (iwCLL) in Cologne, Germany this September.”

About the study
This Phase III study (NCT00748189) included patients with previously untreated CLL considered inappropriate for fludarabine-based therapy.  Patients in the study were randomised 1:1 to treatment with up to twelve cycles of ofatumumab in combination with chlorambucil or up to twelve cycles of chlorambucil alone.  The primary endpoint of the study was PFS according to the International Workshop for Chronic Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines, using an independent endpoints review committee.

About chronic lymphocytic leukaemia
CLL is the most common form of leukaemia 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 curative chemotherapy is available.

About ARZERRA (ofatumumab)
Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL.  For Full US Prescribing Information, please visit: http://us.gsk.com/en-us/products/ and visit health.gsk.com for the EU SPC for the approved indication.

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.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

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®), was approved to treat chronic lymphocytic leukaemia 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.

GlaxoSmithKline Enquiries:

   

UK Media enquiries:

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David Daley

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US Media enquiries:

Bernadette King

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(Philadelphia)

 

Anna Padula

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Analyst/Investor enquiries:

Ziba Shamsi

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Lucy Budd

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Tom Curry

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Gary Davies

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James Dodwell

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Jeff McLaughlin

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(Philadelphia)

Genmab Contact:        
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications

T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

Forward Looking Statement for Genmab
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.

Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a trademark of GlaxoSmithKline.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.


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