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HPV: The Lancet Oncology supports high efficacy previously demonstrated by Cervarix® (HPV 16 and 18 vaccine)

An analysis published today in The Lancet 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 The Lancet Oncology. These data demonstrate that Cervarix® 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 with Cervarix® compared to the control group.5 The most common adverse events associated with Cervarix® include injection site reactions such as pain, redness, swelling and fatigue.6 Cervarix® is a registered trademark of the GlaxoSmithKline group of companies.

1. Lehtinen M, Paavonen J et al. Overall efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvantedvaccine 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 againstcervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a doubleblind, 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 cervicalcancer 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