Lyon, 12th September 2008 – The product information of the four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® has been updated to include a cross-protective effect in preventing precancerous cervical lesions (CIN2/3 and AIS[1]) due to additional cancer-causing HPV not directly targeted by the vaccine.[i]
Cross-protective efficacy was demonstrated in particular against HPV 31 which is the second most common HPV type in Europe in causing precancerous cervical lesions, after type 16. It is also the fourth most common cervical cancer-causing HPV type in Europe, after HPV 16 and 18, and HPV 33.[ii] In fact, HPV type 31 causes almost 25% of the remaining precancerous cervical lesions and 15% of the remaining cervical cancer cases not caused by HPV types 16 and 18.[2]
Gardasil® is the first and only HPV vaccine to have a cross-protective effect added to its product information[3] and to have demonstrated this effect in clinical studies through preventing precancerous cervical lesions, the immediate precursor of cervical cancer.
“We investigated cross-protection through the prevention of precancerous cervical lesions – as we did with direct protection against vaccine-virus types and as recommended by the World Health Organisation (WHO) and the U.S. Food and Drug Administration (FDA) to demonstrate cervical cancer protection. The updated product information confirms our approach,” says Dr. Patrick Poirot, Sanofi Pasteur MSD’s vice-president for Medical and Scientific Affairs.
The efficacy in the prevention of precancerous cervical lesions (CIN 2/3 or AIS)[4] in a combined endpoint that included the ten additional cancer-causing HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, efficacy after up to four years of follow-up was 23%[5]; efficacy for type 31 was 56%[6].
Patrick Poirot adds: “As direct protection is the primary objective of HPV vaccination, our development focused on the demonstration of direct efficacy against precancerous cervical, vulvar and vaginal lesions and genital warts caused by the four HPV types directly targeted by the vaccine. And the impressive global endorsement of Gardasil®'s sustained high efficacy and unique profile proves us right. We are pleased to see that now, even the additional benefits that Gardasil®'s cross-protective effect could bring to women’s health, are being recognised.”
The new product information also includes the prevention of precancerous vaginal lesions (VaIN2/3[7]) due to HPV types 16 and 18 which cause 90% of HPV-related vaginal cancer.[iii],[iv],[8]
“Precancerous vaginal lesions are difficult to detect. The treatment to avoid possible progression to cancer is challenging and often requires ablative therapy, partial vaginectomy and radiotherapy in case of invasive cancer. Recurrence is common,” explains Elmar Joura, professor of gynaeco-oncology at the University of Vienna. “In addition, women may suffer from anxiety, depression, sexual dysfunction and poor self-image.”
Data[v],[vi] from large phase II/III clinical studies confirmed sustained efficacy of 100%[9] of Gardasil® against vaccine virus type-related precancerous vulvar (VIN2/3vii) and vaginal lesions.
