Largest efficacy trial of a cervical cancer vaccine showed Cervarix protects against the five most common cancercausing

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1 FOR IMMEDIATE RELEASE Largest efficacy trial of a cervical cancer vaccine showed Cervarix protects against the five most common cancercausing virus types Published in The Lancet: Additional efficacy could translate into approximately % extra protection against cervical cancer MISSISSAUGA, ON (July 7, 2009) The final analysis of the largest efficacy trial of a cervical cancer vaccine is published today in The Lancet. The study, involving 18,644 women, confirmed GlaxoSmithKline s Cervarix is highly effective at protecting against the two most common cervical cancer-causing human papillomavirus (HPV) types, 16 and The study also showed that the vaccine provides cross-protection against HPV types 31, 33 and 45, the three most common cancer-causing virus types beyond 16 and Cervarix is currently under review with Health Canada. Thomas Breuer, Head of Global Clinical R&D and Chief Medical Officer of GSK Biologicals commented: These excellent study results confirm the efficacy offered by Cervarix against HPV 16 and 18. These results validate that this vaccine was effective against cervical pre-cancers associated with the five most common cancer-causing virus types. This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection against cervical cancer beyond what had at first been anticipated. The study showed that in women who complied with the trial protocol procedures (87 per cent of the total sample), the vaccine provided 92.9 per cent protection against cervical pre-cancers (cervical intraepithelial neoplasia 2+ or CIN 2+) associated with HPV 16 or A further analysis of the same cohort which excluded lesions not likely to be caused by HPV 16 and 18 revealed that the vaccine was 98.1 per cent effective against cervical pre-cancers (CIN 2+) caused by these two types. 1 The study showed for the first time for any cervical cancer vaccine that Cervarix provided significant cross-protection against pre-cancerous lesions not containing HPV types 16 and/or This additional efficacy could translate into approximately % extra protection against cervical cancers over and above the protection afforded by efficacy against HPV 16 and 18 alone. 1 This benefit was mainly driven by protection against HPV types 31, 33 and 45. Dr. Barbara Romanowski, clinical professor of medicine at the University of Alberta, and one of the investigators on the study, commented: These results demonstrate that Cervarix is highly effective against the most common virus types causing cervical 1

2 cancer. In this broad population of 18,644 women, this cervical cancer vaccine was generally safe and well tolerated with a low incidence of side effects. This study is an important development for healthcare professionals and all those working to reduce the incidence of cervical pre-cancers, cervical cancer and the associated diagnostic and surgical procedures." In the study, rates of serious adverse events and medically significant conditions in the group vaccinated with Cervarix were similar to the control group. 1 The Society of Gynecologic Oncologists of Canada (GOC) also made a statement about the study results. "Cervical cancer and its precursors are a significant health problem for women in Canada and around the world. Worldwide, approximately 500,000 women are diagnosed each year with cervix cancer, 80 per cent of whom live in low resource areas, said Dr. Joan Murphy, associate professor at the University of Toronto, J. Douglas Crashley Chair in Gynecological Cancer Research at the University Health Network and co-chair of the GOC Task Force on Cervical Cancer Prevention & Control. GOC welcomes publication of new clinical data that advances our understanding of the role of vaccines as primary prevention of this cancer. Primary prevention via vaccination, along with the success of secondary prevention via screening programs such as Pap smears need to be further studied in longitudinal research programs so that we understand how to integrate all available strategies to most effectively protect women and ultimately to reduce the incidence of cervix cancer to its minimum. This research published in The Lancet is of particular importance because cervical cancer, caused by the HPV virus, is almost entirely preventable and the potential benefit of the vaccine to women worldwide is enormous." For more information or to arrange an interview with a study investigator, please contact: Morgan Cates, Fleishman-Hillard Canada Inc GlaxoSmithKline, Corporate Communications Notes to Editors About HPV 008 PATRICIA (PApilloma TRIal Cervical cancer In young Adults) The Phase lll multi-centre, double-blind, randomised study involved a total of 18,644 women, aged between 15 and 25 years, from 14 countries across Europe, Asia- Pacific and Latin and North America 1 Study participants were randomised to receive either Cervarix or a control hepatitis A vaccine and analyses were performed in the following cohorts: 1 o According-to-protocol cohort for efficacy (ATP-E; vaccine=8093; control=8069) o Total vaccinated cohort (TVC; vaccine=9319, control=9325) o Total vaccinated cohort-naïve (TVC-naïve; vaccine=5822; control=5819) 2

3 ATP-E included all women who met eligibility criteria, complied with the trial protocol and received all three doses of study vaccine 1 TVC included all women who received at least one vaccine dose. This group comprised a diverse population of women including those with evidence of current or previous HPV infection and with high grade smear test results. This was intended to represent a real world, general population of sexually active young women 1 TVC-naϊve included all women who received at least one vaccine dose and who had no evidence of previous or current HPV infection, and was intended to represent the current target population for national immunization; young girls prior to the onset of sexual activity 1 Vaccine efficacy against CIN 2+ associated with HPV 31, 33 and 45 HPV types not in the vaccine was 92 per cent (66.0,99.2; p<0.0001), 51.9 per cent (-2.9, 78.9; p=0.0332) and 100 per cent (-67.8, 100, p=0.0619) respectively in the ATP-E cohort. 1 Vaccine efficacy against CIN 2+ associated with HPV 31, 33 and 45 was 68.4 per cent (34.2, 86.1; p=0 0005), 49.8 per cent (4.8, 74.6; p=0.0239) and 100 per cent (7.0, 100; p=0.0312) respectively in the TVC cohort 1 Vaccine efficacy against CIN 2+ lesions associated with 12 non-vaccine cancercausing HPV types not in the vaccine was 54 per cent (34.0, 68.4; p<0.0001) in the ATP-E cohort. 1 When excluding all CIN 2+ lesions associated with non-vaccine types in which HPV 16 and 18 was also detected, vaccine efficacy was 37.4 per cent (7.4, 58.2; p=0.0092) in the ATP-E cohort. 1 These two analyses suggest that the true vaccine efficacy against CIN 2+ associated with 12 non-vaccine cancer-causing HPV types lies between 37 per cent and 54 per cent 1 The vaccine also substantially reduced the number of colposcopy referral and cervical excision procedures in both the TVC and TVC-naïve cohorts 1 The efficacy and safety results from the interim analysis of the HPV 008 study were previously published in The Lancet. 2 The data reported today are from the final event driven analysis, also published in The Lancet. Further to the final analysis, additional follow-up results will be forthcoming from the end of study About Cervarix Cervarix was specifically designed with a novel adjuvant system, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against HPV 16, and 18, the most common cervical cancer-causing HPV types. 1 Additional protection has been observed against HPV types 31, 33, and 45. The vaccine has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site, fatigue, fever, aching, headache, itching, rash or gastrointestinal disturbances. 4 To date, Cervarix has been approved in 97 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 Canada, Japan and the United States. About HPV and cervical cancer Women are at risk of HPV infection throughout their sexually active lives. 5 Approximately 100 types of HPV have been identified to date 6 and, of these, approximately 15 virus 3

4 types are known to cause cervical cancer. 7 HPV types 16 and 18 are responsible for approximately 70 per cent of cervical cancers globally, with types 45, 31 and 33 among the next most common cervical cancer-causing HPV types. 8,9 These leading 5 types represent over 82% of cervical cancers. 15 Persistent infection with cancer-causing HPV types can lead to abnormal Pap smears, cervical pre-cancer and cervical cancer. Cervical intraepithelial neoplasia (CIN), graded as CIN 1, 2 and 3 refers to precancerous cells found on the surface of the cervix. The higher the grading number, the higher the probability the abnormal cells will become cancer cells. 10 CIN 1, 2 and 3 refers to mild, moderate or severe cell changes respectively. CIN 2+ is the surrogate marker for cervical cancer. Worldwide, more than 500,000 women will be newly diagnosed with cervical cancer and 280,000 women will die from it each year. 11 HPV types 16, 18 and 45 are particularly important because these types are associated with nearly 90 per cent of adenocarcinoma cases, 8 a very aggressive type of cervical cancer more common in younger women and more difficult to detect through screening. 12,13 According to the Canadian Cancer Society s Canadian Cancer Statistics 2008 report, 1,300 new cases of cervical cancer are diagnosed each year, and 380 women die each year of the disease. 16 Cervical cancer ranks the 11 th most frequent cancer in women, and the second most frequent cancer among women age About 21.7% of women in the general population are estimated to live with cervical HPV infection at any given time, and 71 per cent of invasive cervical cancers in Canada are attributable to HPVs 16 or In addition, over 400, 000 Canadian women each year may experience early precancerous lesions and pap test abnormalities. 17 About GlaxoSmithKline, Inc. (Canada) GlaxoSmithKline one of the world s leading research-based pharmaceutical, vaccine and health-care companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer. In Canada, GlaxoSmithKline is among the top 15 investors in research and development, contributing more than $156 million in 2008 alone. GSK is designated a Caring Company by Imagine Canada, and is consistently recognized as one of the 50 best companies to work for in Canada. For company information please visit, Cervarix is a trademark of the GlaxoSmithKline group of companies. References 1. Paavonen J et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against cervical infection and pre-cancer caused by oncogenic HPV types: final event-driven analysis in young women (the PATRICIA trial) Published online, The Lancet July Pavonen J et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young 4

5 women: an interim analysis of a phase III double-blind, randomised controlled trial. The Lancet 2007; 369: Agilar JC. Vaccine adjuvants revisited. Vaccine 2007; 25: Descamps D, Hardt K, Spiessens B et al. Safety of human papillomavirus (HPV)- 16/18 AS04 adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Human Vaccine, 2009; 55: Baeman JG, Koutsky LA. The epidemiology of human papillomavirus infections J Clin Virol 2005; 32 Suppl 1; S WO. 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 at 7. Muñoz N, Bosch FX, de Sanjose S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: Bosch X, Burchell A, Schiffmann M et al. Epidemiology and Natural History of Human Papillomavirus Infections and Type-Specific Implications in Cervical Neoplasia. Vaccine 26S (2008) K1 K Cohen J. High Hopes and Dilemmas for a Cervical Cancer Vaccine. Science 2005; 308: Cancer Research UK accessed on 11 June 2009 at World Health Organization. Initiative for Vaccine Research. Accessed on February 13, Castellsagué X et al. Worldwide Human Papillomavirus Etiology of Cervical Adenocarcinoma and Its Cofactors: Implications for Screening and Prevention. Journal of the National Cancer Institute 2006; 98 (5): Bulk S et al. Incidence and survival rate of women with cervical cancer in the Greater Amsterdam area. British Journal of Cancer 2003; 89: Canadian Cancer Society/National Cancer Institute of Canada: Canadian Cancer Statistics 2008, Toronto, Canada, April 2008, ISSN WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Summary Report on HPV and cervical cancer statistics in Canada Accessed May 11, p iv. at 204&CFTOKEN= Canadian Cancer Society/National Cancer Institute of Canada. Canadian Cancer Statistics 2008, Toronto, Canada p Society of Obstetricians and Gynaecologists of Canada (SOGC) Statement on CMAJ Commentary, Human papillomavirus, vaccines and women s health: questions and cautions. Accessed on July 6, 2009 at: 5