Data published in The Lancet Oncology support high efficacy previously demonstrated by Cervarix® (HPV 16 and 18 vaccine) against precancerous cervical lesions

Issued: London UK

An analysis published today in TheLancet Oncology reinforces previous findings showing that GlaxoSmithKline’s Cervarix^®, provided protection against advanced precancerous lesions (CIN3+), above that expected from a vaccine that protects against human papillomavirus (HPV) types 16 and 18. CIN3+ is the immediate step before invasive cervical cancer and data showing protection against this type of lesion are considered the most stringent evidence of potential cervical cancer prevention.¹

Results from the largest efficacy trial of a cervical cancer vaccine to date (PATRICIA), show that Cervarix provided 93%^† efficacy against CIN3+ irrespective of the HPV type associated with the CIN3+ lesion.¹ This pre-defined, exploratory analysis was conducted in women with no evidence of past or current HPV infection.^‡ These women are thought to be representative of young girls prior to the onset of sexual activity – the primary target population for organised vaccination programmes. These findings have been incorporated into the European label for Cervarix, updated by the European Commission in September 2011.

Additional data from the same end-of-study analysis have been published in a separate article in TheLancet Oncology. These data demonstrate thatCervarix provided 82%* efficacy against CIN3+, associated with a composite of 12 cancer-causing HPV types not included in the vaccine, in the same population as the analysis discussed above.² This analysis excluded cases co-infected with HPV 16 and/or 18 and is therefore a conservative estimate of cross-protective efficacy. Non-vaccine HPV types, including the 12 studied in this analysis, together account for approximately 30% of cervical cancers globally.³

The authors of this article anticipate that Cervarix,when administered to HPV-naïve subjects, may provide protection against cervical cancer above that expected for a vaccine that protects against HPV 16 and 18, but long-term follow-up is needed to confirm this.²

The data support the high efficacy previously demonstrated by Cervarix against precancerous cervical lesions caused by HPV 16 and 18 and also efficacy against certain other cancer-causing HPV types.⁴

Cervarix is generally well tolerated.⁴ An integrated safety analysis of Cervarix performed in almost 30,000 women aged 10-72 years from ethnically and geographically diverse backgrounds over a period of up to 5.5 years has shown no clinically significant differences in serious adverse events in women vaccinated withCervarix compared to the control group.⁵ The most common adverse events associated with Cervarixinclude injection site reactions such as pain, redness, swelling and fatigue.⁶

Cervarix^® is a registered trademark of the GlaxoSmithKline group of companies.  

Notes to editors

^† 93.2% CI: 78.9-98.7

^‡ For the primary endpoint of the study, Cervarix demonstrated 92.9% efficacy against CIN2+ associated with HPV-16 and/or 18 (96·1% CI: 79·9; 98·3).⁴ These results are from the ‘according to protocol-efficacy cohort’, final analysis. The according to protocol cohort represents women who received 3 vaccines doses, met all eligibility criteria and complied with protocol.

^* 81.9% CI: 17·1- 98·1

About HPV-008 PATRICIA (PApilloma TRIal Cervical cancer In young Adults) ⁴

• 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.
• Study participants were randomised to receive either Cervarix^® or a control hepatitis A vaccine and a nalyses were performed in the following cohorts:
  • According-to-protocol cohort for efficacy (ATP-E; vaccine=8093; control=8069)
  • Total vaccinated cohort (TVC; vaccine=9319, control=9325)
  • Total vaccinated cohort-naïve (TVC-naïve; vaccine=5822; control=5819)/li>
• ATP-E included all women who met eligibility criteria, complied with the trial protocol and received all three doses of study vaccine.
• 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 general population of sexually active young women.
• TVC-na?ve included all women who received at least one vaccine dose and who had normal cytology, no evidence of previous or current HPV infection, and was intended to represent young girls prior to the onset of sexual activity.
• The efficacy and safety results from the interim analysis as well as the final event-driven analysis of the HPV 008 study were published in The Lancet.

About Cervarix

Cervarix is a vaccine developed to help protect women against cervical cancer. It was specifically designed with a proprietary adjuvant, AS04, to deliver high and sustained levels of antibodies.⁷ It has been shown to be generally well tolerated.⁴  In clinical trials, the most common symptoms after vaccination included pain, redness and swelling at the injection site, fatigue, fever, aching, headache, itching, rash or gastrointestinal disturbances.⁶

To date, Cervarix has been approved in over 110 countries including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico, Taiwan, Japan and the United States and GSK has also received prequalification for the vaccine from the World Health Organization (WHO) in July 2009.

The Summary of Product Characteristics for Cervarixcan.

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.

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 vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields.

GlaxoSmithKline Enquiries:

GlaxoSmithKline 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 2010.

References

1. Lehtinen M, Paavonen J et al. Overall efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia grade 3 or greater: end-of-study analysis of the randomised, double-blind PATRICIA trial. The Lancet Oncology. Published Online First, 9 November 2011
2. Wheeler CM, Castellsagué x et al. Cross-protective efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types (PATRICIA randomised trial). The Lancet Oncology. Published Online First, 9 November 2011
3. De Sanjose S et al. . Human papillomavirus genotype attribution in invasive cervical cancer: a retrospectivecross-sectional worldwide study The Lancet 2010;11:1048–1056
4. Paavonen J, Naud P et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double blind, randomised study in young women. The Lancet. 2009; 374:301-314
5. Descamps D et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Human Vaccines 2009:5:5, 1-9
6. Cervarix® Summary of Product Characteristics, GlaxoSmithKline 2011.
7. Aguilar JC. Vaccine adjuvants revisited. Vaccine. 2007; 25: 3752-3762