Gardasil's efficacy confirmed in Ph II/III program with 20,000 women

A combined analysis of four Phase II/III studies which enrolled more than 20,000 women confirmed that the quadrivalent (6,11,16,18) cervical cancer vaccine Gardasil demonstrates 98% to 100% efficacy in the prevention of vaccine virus type-related precancerous cervical lesions in young women, noted Sanofi Pasteur MSD, the joint venture between France's Sanofi-Aventis and the USA's Merck & Co which makes the vaccine. The new data were presented at the International Congress on Anti-Cancer Treatment, held in Paris, France. "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," said lead study investigator Elmar Joura. In light of the high and sustained efficacy of Gardasil, the independent Data and Safety Monitoring Board of the Phase III studies recommended that they be terminated as soon as possible so that those in the placebo group could also benefit from the agent.