New data for GlaxoSmithKline’s vaccine, Cervarix®, presented at IPV Conference
London, UK & Malmö, Sweden
Key results from three important studies of the cervical cancer vaccine, Cervarix®, will be available as of today at the 25th International Papillomavirus Conference (IPV) in Malmö, Sweden.
Comparative trial of Cervarix® and Gardasil® (Study 010)
Results from the first, large-scale comparative trial between licensed human papillomavirus (HPV) vaccines show that Cervarix® generated a significantly higher immune response compared to Gardasil® .1 The comparative study looked at two key measures of immune response, neutralising antibodies and memory B cells. Although the post-vaccination immune correlates of protection for cervical cancer are still unknown, neutralising antibodies and B cells are believed to play an important role in protecting women from HPV infection and subsequent cervical cancer over the long term.2-7 Across all ages studied (women 18 – 45 years), neutralising antibody levels for Cervarix ® were more than two times higher than those for Gardasil ® for HPV type 16, and more than six times higher for HPV type 18. These results were highly statistically significant (p less than 0.0001).1 In addition, the proportion of women with detectable levels of neutralising antibodies in cervical secretions was higher in the group that received Cervarix® .1 Compared toGardasil® , GSK’s vaccine also produced nearly three (2.7) times more memory B cells for HPV types 16 and 18.1
Compliance with the full vaccination course was high and comparable for both vaccines8 which indicates that both were well tolerated. Rates of solicited symptoms were higher for Cervarix® with injection site reactions being most common.8 However, in both groups solicited symptoms tended to be of short duration. It is expected that the full results from this comparative study will be published in a peer reviewed journal.
Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: “The presence of neutralising antibodies at the location of the infection (the cervix) appears to be an important part of vaccine-induced protection against HPV. This study offers the first evidence that these two vaccines do not generate the same immune response against HPV types 16 and 18, the two most common cancer-causing virus types. We are confident that these results, along with new results from additional key studies being presented this week, demonstrate the potential of Cervarix® .”
Phase III efficacy trial (Study 008)
Results from the final analysis of the Phase III study (HPV-008) will be presented for the first time at the conference, showing that Cervarix® provided a high and statistically significant level of efficacy against pre-cancerous lesions associated with each of the HPV types included in the vaccine (HPV 16 and HPV 18).9 In addition,the data demonstrated that the vaccine also provided type-specific protection against pre-cancerous lesions associated with some additional common cancer-causing HPV types other than HPV 16 and HPV 18.10 In women without evidence of prior cancer-causing HPV infection the overall efficacy demonstrated against any lesion, regardless of HPV type, was much greater than would be expected for a vaccine targeting only HPV types 16 and 18.11
Rates of serious adverse events and medically significant conditions were similar between study and control groups.9 These data have been submitted to regulatory authorities including the US FDA and publication is expected in a peer reviewed journal.
Long term follow up study (Study 023)
Results from a third study to be presented in Malmö show that GSK`s cervical cancer vaccine provided high and sustained antibody levels against HPV 16 and HPV 18 through the 7.3 years of follow up after vaccination. This is the longest follow up reported to date for any licensed HPV vaccine.12
Jean Stéphenne, President and General Manager of GlaxoSmithKline Biologicals said, “Preventing cervical cancer is a public health priority in both developed and developing countries. We are pleased with these findings and how they can further the understanding of the role of Cervarix ® in helping to protect women against cervical cancer"
Notes to editors
About HPV 008
The efficacy and safety results from the interim analysis of the HPV 008 study were previously published in The Lancet.13 The data presented at the 25th International Papillomavirus Conference (IPV) are from the final event driven analysis. Further follow up results will be forthcoming from the end of study analysis in due course.
About the HPV vaccines
Cervarix ® provides protection against the most common cancer-causing virus types – HPV 16 and 18.9 Gardasil ® provides protection against HPV 6, 11, 16 and 18.
Cervarix ® was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against the most common and aggressive HPV types.14 It has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site.15
To date, Cervarix ® has been approved in 95 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including Japan and the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.
About HPV and cervical cancer
Women are at risk of HPV infection throughout their sexually active lives.16 Approximately 100 types of human papillomavirus have been identified to date17 and, of these, approximately 15 virus types are known to cause cervical cancer.18 HPV types 16 and 18 are responsible for approximately 70 percent of cervical cancers globally, with types 45, 31 and 33 among the next most common cancer-causing HPV strains.19,20 Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer21 and 280,000 women will die from it each year.21
GlaxoSmithKline Biologicals – GSK Biologicals, GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 13 manufacturing sites strategically positioned around the globe. In 2008 GSK Biologicals distributed 1.1 billion doses of vaccines to 176 countries in both the developed and the developing world – an average of 3 million doses a day.
Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to discover innovative vaccines that contribute to the health and well-being of people of all generations around the world.
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
Cervarix ® is a registered trademark of the GlaxoSmithKline group of companies.
Gardasil ® is a registered trademark of Merck & Co., Inc.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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 ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2008.
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10. Skinner SR et al. Cross-protective efficacy of Cervarix™ against oncogenic HPV types beyond HPV-16/18. Abstract presented at the 25th International Papillomavirus Conference (IPV) 8-14 May 2009; Malmo, Sweden
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12. De Carvalho N et al. Immunogenicity and safety of HPV-16/18 AS04-adjuvanted vaccine up to 7.3y. Abstract presented at the 25th International Papillomavirus Conference (IPV) 8-14 May 2009; Malmo, Sweden
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17. WHO. Expert Committee on Biological Standardization. Guidelines to assure the quality, safety and efficacy of recombinant Human Papillomavirus virus-like particle vaccines, accessed on 27/3/2009
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20. Cohen J. High Hopes and Dilemmas for a Cervical Cancer Vaccine. Science 2005; 308: 618-621
21. World Health Organization. Initiative for Vaccine Research. Accessed on February 13, 2009
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