Encouraging clinical activity of GSK's novel cancer immunotherapeutic confirmed in phase II study in patients with most common form of lung cancer

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DATA ON ABSTRACT NO: 7554 EMBARGOED UNTIL TUESDAY JUNE 5, 2007, 14.00, BST

GSK announces launch of largest ever phase III clinical trial in lung cancer treatment

GlaxoSmithKline (GSK) today announced final results of a Phase II proof-of-concept clinical trial of its investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) in MAGE-A3 positive patients with stage IB or II Non-Small Cell Lung Cancer (NSCLC). These data were presented at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois, [Abstract No: 7554]. Final trial analysis showed a 27% reduction in the relative risk of cancer recurrence following surgery in patients treated with the MAGE-A3 ASCI, compared to placebo.

“Final results from this trial confirm the positive interim results released last year at ASCO 2006, and support expanded testing of this novel cancer immunotherapy,” said Paul A. Bunn Jr., M.D., James Dudley Endowed Professor of Oncology, Professor of Medicine and Director of the University of Colorado Cancer Center, Aurora, Colorado. “This approach represents a potentially momentous shift in the cancer treatment paradigm. I believe we have only just scratched the surface of what is possible and look forward to seeing the results of the Phase III trial in due course.”

Based on these encouraging data, GSK also announced today the opening of patient recruitment to the randomised and controlled Phase III efficacy and safety trial for this novel cancer immunotherapy; the largest clinical trial ever conducted in lung cancer treatment. MAGE-A3 ASCI will be evaluated as adjuvant therapy in about 2,270 MAGE-A3 positive patients with completely resected stage IB, II or IIIA NSCLC.

GSK’s ASCIs aim to stimulate the patient’s own immune response to identify and attack cancer cells in a highly specific manner. This novel cancer immunotherapy is developed using tumour specific antigens, delivered as highly purified recombinant proteins, and GSK’s own proprietary Adjuvant Systems, which are specifically designed to enhance ASCIs anti-tumour activity

Phase II NSCLC clinical trial results

This Phase II double-blind, placebo-controlled study is the first proof-of-concept trial for an ASCI in early NSCLC. The study randomised 182 patients with completely resected stage IB or II NSCLC to receive either MAGE-A3 ASCI or placebo as adjuvant therapy. All patients participating in the trial had cancers expressing a tumour-specific antigen known as MAGE-A3, which is present in approximately 35% to 50% of early NSCLC.1

The final analysis was performed at a median follow-up of 28 months. At this time, 41 of the 122 patients receiving MAGE-A3 relapsed (30.6%); in comparison to 26 of the 60 patients receiving placebo (43.3%). Using a Cox regression model to adjust for the fact that patients in the different arms were enrolled in the study at different times, there was a 27% reduction in the relative risk of cancer recurrence following surgery, compared with placebo (p=0.107). Although the study was not powered to show statistical significance, the trend is encouraging and warrants continued clinical investigation of MAGE-A3 ASCI.

In the Phase II clinical study, the most commonly reported adverse events were mild local (pain, redness, swelling) or systemic (fever, fatigue, muscle pain) reactions observed within the 24 hours of injection. Out of 182 patients, one patient was withdrawn from the clinical trial due to adverse events possibly related to the MAGE-A3 treatment. Based on available results, GSK’s MAGE-A3 ASCI may have the potential to be suitable for maintenance therapy delivered intra-muscularly on an outpatient basis.

Phase III non-small cell lung cancer trial launch

GSK is now recruiting for a Phase III trial evaluating MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. With a target of about 2,270 patients, the randomized, double-blind, and placebo-controlled MAGRIT trial (MAGE-A3 as Adjuvant Non-Small Cell Lung Cancer Immunotherapy) will enroll patients with stage IB, II or IIIA resectable NSCLC. The ASCI administration will be initiated in two groups of patients: after surgery and standard chemotherapy in one group of patients and after surgery in patients who are not receiving chemotherapy. The primary endpoint of the trial is disease-free survival.

“GSK recognises the need for further investigation of MAGE-A3 in Non-Small Cell Lung Cancer and we are therefore pleased to open the clinical trial recruitment for Phase III to continue to evaluate this exciting cancer therapy,” said Vincent Brichard, Vice President of the ASCI Programme at GSK Biologicals. “We believe ASCIs may mark the start of a new generation of cancer treatments, with significant potential across various cancer types.

About ASCIs and MAGE-A3 ASCI

GSK’s ASCIs represent a novel class of medicines designed to train the immune system to recognise and eliminate cancer cells in a highly specific manner. These novel cancer immunotherapeutics combine tumour antigens, delivered as purified recombinant proteins, and GSK’s proprietary Adjuvant Systems which are specific combinations of immunostimulating compounds selected to increase the anti-tumour immune response. ASCIs may be used to reduce the risk of tumour recurrence following surgery, or to impact tumour growth in an early metastatic setting.

The highly specific mode of action of GSK’s ASCIs may not only avoid harming the normal tissue but also aid in selecting patients eligible for the treatment, depending on the expression of the tumour antigens.

MAGE-A3 is a tumour-specific antigen that is expressed in a large variety of cancers, including Non-Small Cell Lung Cancer, Head and Neck Cancer, Bladder Cancer, with no expression in normal cells. Expression of the MAGE-A3 gene has been observed in testicular cells but without antigen presentation capabilities.

MAGE-A3 antigen has been in-licensed by GSK from the Ludwig Institute for Cancer Research, the largest international academic institute dedicated to understanding and controlling cancer. MAGE-A3 ASCI is an investigational compound and it is not approved for use in any indication in any country at this time.

About non-small cell lung cancer

According to the World Health Organisation (WHO), more than 1.3 million new cases of lung and bronchus cancer are diagnosed each year worldwide.[1] The American Cancer Society estimates that approximately 213,380 new cases of lung and bronchus cancer and more than 162,000 related deaths will occur in the United Statesin 2007. It is the leading cause of cancer death in the United Statesfor both men and women. Non-Small Cell Lung Cancer is the most common form of lung cancer, accounting for about 80 to 85% of all lung cancers.[2] Approximately 35% to 50% of early NSCLC expresses MAGE-A3.1

About GlaxoSmithKline and GlaxoSmithKline Biologicals

GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. GSK Bio is also developing innovative immunotherapy compounds to treat cancer patients.

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 company information please visit www.gsk.com.

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Cautionary statement regarding forward-looking statements

Under the safe harbour provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, 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 the Group's operations are described under 'Risk Factors' in the `Business Review’ in the company's Annual Report on Form 20-F for 2006.

[1] World Health Organisation — Cancer — Fact Sheet n° 297 (February 2006) (www.who.int).

[2] American Cancer Society Website (www.cancer.org), Cancer Statistics 2006 presentation.

 

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