Cervarix shows long-term protection from cervical cancer

Mar 12 2008

New data demonstrate that GlaxoSmithKline's cervical cancer candidate vaccine, Cervarix provides significant protection for women against the four most common cancer- causing human papillomavirus types for nearly six and a half years, the longest duration of protection reported to date.

Over this time, the cervical cancer candidate vaccine showed 100 percent efficacy in preventing precancerous lesions due to cancer-causing virus types 16 and 18 and also provided substantial protection against infection caused by virus types 31 and 45.

These data show that virtually 100 percent of women in the study, 15-25 years of age, maintained high levels of antibodies against both virus types 16 and 18 at every time point for nearly six and half years. This signifies the longest duration of consistently high antibody levels demonstrated by a cervical cancer vaccine. Antibody levels remained several times higher than natural infection levels over the extended period of time.

"With this trial, we continue to see high levels of antibodies that lasted over time in virtually all women studied, which is critical for the prevention of cervical cancer," said Diane Harper, MD, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, NH. "These data are remarkable as they show the potential for this cervical cancer vaccine to protect women over the long term."

The study also confirmed substantial cross-protection for nearly six and a half years against incident infection caused by virus types 45 and 31. Specifically, the vaccine showed 78 percent efficacy in preventing incident infection caused by virus type 45, and 60 percent efficacy in preventing incident infection caused by virus type 31.

Virus types 18 and 45 are responsible for a significant percentage of a particularly aggressive and deadly form of cervical cancer known as adenocarcinoma. This type of cervical cancer tends to occur in younger women and is not well detected by routine screening methods.

"We specifically designed our cervical cancer vaccine with the goal of providing long-lasting protection from cervical cancer," said James Tursi, MD, Director of Medical Affairs, North America, GlaxoSmithKline. "These study results are important because women remain at risk for infection with cancer- causing virus types throughout their lives, and long-term protection will be an essential component of a successful vaccination strategy."

The results also include safety data from nearly six and a half years, showing that the candidate vaccine had no meaningful differences between the study groups and had a favorable overall safety profile.