HPV Vaccine Gardasil Sustains Efficacy In Treating Precancerous Lesions, New Data Show

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 08 Feb 2008 - 5:00 PST

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Merck's human papillomavirus vaccine Gardasil sustained 98% to 100% efficacy in preventing precancerous lesions and preventing cervical cancer, according to a combined analysis of four Phase II and Phase III clinical trials, Reuters reports. The analysis -- presented at the 19th International Congress on Anti-Cancer Treatment in Paris -- involved more than 20,000 women. According to Reuters, independent monitors recommended terminating the Phase III trials so that the benefits of Gardasil could be given to the placebo group (Hirschler, Reuters, 2/7).

Gardasil in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 1/28). The company said the new results are consistent with previous data from a five year follow-up of the Phase II clinical trial in a smaller population. Merck added that Gardasil has been shown to induce immune memory, which means that the immune system can be expected to provide protection when exposed again to these virus types, even many years later.

Patrick Poirot -- vice president for medical and scientific affairs at Sanofi Pasteur, a joint company of Merck and Sanofi-Aventis that markets Gardasil in Europe -- said the results "exten[d] the robustness of the data from a few hundred to many thousand women" (Dow Jones/CNNMoney.com, 2/7). Elmar Joura of the University of Vienna said, "The results ... include by far the longest follow-up for any cervical cancer vaccine in large Phase III studies and strongly substantiate the evidence that the protection provided by Gardasil will be long-lasting" (Reuters, 2/7).

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