Press release: GSK Vaccines to transfer tumour samples and data to the European Organisation for Research and Treatment of Cancer

GlaxoSmithKline (GSK) and the European Organisation for Research and Treatment of Cancer (EORTC) have entered into an unprecedented agreement for the transfer of human biological samples and clinical data collected by GSK as part of cancer immunotherapeutic research in its vaccines business. This transfer of samples and clinical databases, which resulted from GSK cancer research programmes including the MAGE-A3 programme, is unique because of the large scale of the material being made available and the type of clinical data associated with the samples. This transfer will help to create an array of new opportunities for cancer research and patients.

This vast tumour sample collection and the studies’ clinical databases represent a highly valuable scientific resource with the potential to support innovation in the field of immunotherapeutic cancer research. This biobank has been held by GSK since the end of a number of vaccines immunotherapeutic trials in 2015 in line with the Independent Data Monitoring Committees (IDMC) recommendation. Data from these studies has also been shared with GSK’s pharmaceuticals R&D organisation, where immunotherapy and oncology remain key focus areas for ongoing research.

At a time when new technologies allow a better understanding of cancer biology and mechanisms of action of treatments, the use of datasets and human biological collections to advance avenues of new therapies provides a source of hope for millions of cancer patients around the world.

“Scientific partnerships are crucial to how we work in R&D at GSK, and facilitating innovation outside of GSK is part of this commitment. This unique transfer of samples and associated data were created by years of studies and passion from our scientists, and we are proud to share those with the EORTC to contribute to the fight against cancer”, said Dr Emmanuel Hanon Senior Vice-President and Head of R&D, Global Vaccines GSK. “Collaborations like this are evidence of the central role that GSK plays in the wider scientific community, and this transfer could be an important step in cancer research, enabling transformative science breakthroughs for patients.”

“Non-commercial and commercial clinical research are complementary. In recent years we have seen the emergence of new forms of partnerships which attempt to optimize and combine strengths of various stakeholders for faster and tailored delivery of therapeutic progress” said Dr Denis Lacombe, EORTC Director General. “Together the scientific community must ensure to patients that their contribution to research is optimized. This example of a partnership opens new innovative routes beyond the silos which often exist in drug development and clinical research. It represents tremendous opportunities for the research and patients communities.”

About the transfer

GSK is currently transferring custodianship of the human biological tumour samples to the EORTC and is providing access to the associated clinical data. This agreement is compliant with GSK Internal Control Framework (ICF) methodology based on recognized international risk management standards. The human biological sample transfer has been approved by the independent Ethics Committee at the Erasme Hospital in Brussels. The Belgian Data Privacy Commission has provided its endorsement for the secured way of data transfer from GSK to the EORTC and for strict rules to maintain secure data handling under the responsibility of the EORTC. These governance measures will ensure compliance with all applicable laws, establish the IT process for protection of personal data, and secure necessary approval from regulatory authorities. The agreement also ensures that all appropriate standards with respect to the integrity and confidentiality of the materials are met, and that information on the informed consent related to those materials is shared with the EORTC.

About the studies

As part of the transfer, GSK will share information and samples from two large Phase III studies, MAGRITⁱ (non-small lung cancer) and DERMAⁱ (melanoma), which were not progressed:

• MAGRIT: A double-blind, randomised, placebo-controlled Phase III trial to assess the efficacy of rec MAGE-A3 + AS15 antigen-specific cancer immunotherapeutic as adjuvant therapy in patients with MAGE-A3 positive NSCLC. Patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months (MAGRIT, NCT00480025); The MAGRIT trial screened 13 849 patients and finally enrolled 2,312 MAGE-A3-positive patients across more than 400 sites in 34 countries worldwide. The trial did not meet its first or second co-primary endpoint as it did not significantly extend DFSⁱⁱⁱ when compared to placebo in either the overall MAGE-A3 positive population or in those MAGE-A3-positive patients who did not receive chemotherapy.

See also, JF Vansteenkiste et al. The Lancet Oncology, 2016;17(6):822-835.  http://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(16)00099-1.pdf

• DERMA: A Phase III trial of the GSK MAGE-A3ⁱⁱ cancer immunotherapeuticⁱⁱ, stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene and had their tumours removed surgically. This randomised, blinded, placebo- controlled trial study in melanoma evaluated whether a gene signature could identify a sub population of melanoma patients that would have benefited from the same investigational MAGE-A3 cancer immunotherapeutic; The DERMA trial screened 3 914 patients and finally enrolled 1,391 MAGE-A3-positive patients across more than 250 sites in 31 countries worldwide. An independent analysis of the DERMAⁱ study showed in 2015 that the study did not meet its first or second co-primary endpoints as it did not significantly extend disease-free survival (DFSⁱⁱⁱ) when compared to placebo in the MAGE-A3 positive population.

See also, B. Dreno et al., The Lancet Oncology 2018;19(7): 916–929. https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-2045(18)30254-7.pdf

Notes to editors

• ⁱA double-blind, randomised, placebo-controlled Phase III trial to assess the efficacy of recMAGE-A3 + AS15 antigen-specific cancer immunotherapeutic as adjuvant therapy in patients with MAGE-A3 positive NSCLC. Patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months. (MAGRIT, NCT00480025)
• ⁱⁱMAGE-A3 is a tumour-specific antigen expressed in a variety of cancers but not in normal cells. In non-small lung cancer (NSCLC), it is expressed in approximately one third of tumours in patients diagnosed with Stage IB-IIIA disease.
• ⁱⁱⁱMAGE-A3 cancer immunotherapeutic consists of recombinant MAGE-A3 protein and a novel immunostimulant AS15 (a combination of QS-21 Stimulon® adjuvant, monophosphoryl lipid A, and CpG7909, a TLR-9 agonist, in a liposomal formulation). QS-21 Stimulon® adjuvant is licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN).

About EORTC (European Organisation for Research and Treatment of Cancer):

European Organisation for Research and Treatment of Cancer conducts clinical research in cancer, defining new standards of practice for better treatment and care of cancer patients.  EORTC network comprises more than 5500 multidisciplinary collaborators in more than 930 hospitals and institutions in 27 countries. For more information, visit www.eortc.org.

About GSK:

GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com

EORTC enquiries

• Davi Kaur +3227741513 – Belgium

GSK enquiries

• Simon Moore +44 (0) 20 8047 5502 – London
• Anne Decours +32 (0)470 20 50 95 – Belgium

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. Such factors include, but are not limited to, those described under Item 3.D ‘Principal risks and uncertainties’ in the company’s Annual Report on Form 20-F for 2017.