• 10/21/2007
  • Atlanta, GA
  • By Peggy Peck, Managing Editor, MedPage Today
  • MedPageToday.com

Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18]) appears to be 100% effective against HPV-related vaginal and vulvar lesions, researchers reported here.

This vaccine has won endorsement by an FDA advisory committee for cervical cancer and was expected to win agency approval for that indication this week.

Meanwhile, at the American Society of Clinical Oncology meeting here, Jorma Paavonen, M.D., of the University of Helsinki in Finland, said HPV is present in about 80% of vaginal and vulvar cancers.

In a pre-specified modified intention-to-treat combined analysis of data from the three randomized, placebo-controlled Gardasil clinical trials, there were 24 cases of vulvar or vaginal intraepithelial neoplasia in the placebo arm and no cases in the active treatment arm after an average of two years of follow-up, he said.

“These findings support the prophylactic efficacy of Gardasil in preventing HPV-16 and HPV-18-related vulvar and vaginal cancer,” Dr. Paavonen said at an ASCO press briefing here.

Dr. Paavonen said the data he reported here were made available to the FDA, “but have not been previously reported or published.”

The analysis included data from 8,641 women ages 16 to 26 who received three doses of the vaccine and 8,667 women who received three placebo injections. The women were recruited from the U.S. as well as South America, Europe and Asia.

Dr. Paavonen said that the health ministry in Finland is planning to include the HPV vaccine as a standard childhood immunization “so that we may actually eradicate the HPV-related diseases.”

Robert F. Ozols, M.D., Ph.D., of the Fox Chase Cancer Center in Philadelphia said he hopes the U.S. “will overcome political objections” and follow “the example from Finland.” The prospect of vaccinating young children against a sexually transmitted disease has stirred political controversy.

Dr. Ozols, who moderated the ASCO press briefing, noted that the vaccine can also protect against genital warts “which are also a problem for males, so I think that both boys and girls should be vaccinated.”

Dr. Paavonen said that the data from the phase III trials of Gardasil indicated that it would be protective against “90% of genital warts.”

On May 18, FDA advisers recommended unanimously that the FDA approve Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18]), a cervical cancer vaccine.

The FDA advisory committee also reviewed results from immunogenicity studies in males and females ages nine to 15 that demonstrated a higher immune response in younger participants than in older adolescents and adults. It agreed that “the immunogenicity data for the younger female population support the bridging of the efficacy data from the older female population to the younger female population.”