Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that in the pivotal Phase III efficacy study, its investigational 9-valent HPV vaccine (V503) prevented approximately 97 percent of cervical, vaginal and vulvar pre-cancers caused by HPV types 31, 33, 45, 52, and 58. V503 also generated immune responses to HPV types 6, 11, 16, and 18 that were non-inferior to those generated by GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. V503 includes five more HPV types (31, 33, 45, 52, 58) in addition to the four original HPV types (6, 11, 16, 18) in GARDASIL. These data, along with results of two other Phase III studies, will be presented for the first time at the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) Congress during a late-breaker oral session on Tuesday, November 5.
Results from the pivotal Phase III efficacy study (abstract #SS 8-4)
The pivotal Phase III study (Protocol 001) evaluated the efficacy, safety and immunogenicity of V503 (n=7,099) compared to GARDASIL (n=7,105) in 16-26-year old females. The primary efficacy analysis was conducted in those who received all three doses of vaccine within one year, who were not infected with the relevant HPV types at enrollment and who remained free of infection with the relevant HPV types through Month 7 (per-protocol population). The results were as follows:
- 96.7 percent reduction (95% CI; 80.9, 99.8) in the combined incidence of high-grade cervical/vulvar/vaginal disease [CIN (cervical intraepithelial neoplasia) 2/3+, VIN (vulvar intraepithelial neoplasia) 2/3+, and VaIN (vaginal intraepithelial neoplasia) 2/3+] caused by HPV types 31, 33, 45, 52, 58 (1 case in the group that received V503 vs. 30 cases in the group that received GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]).
- 97.1 percent reduction (95% CI; 91.8, 99.2) in the combined incidence of cervical/vulvar/vaginal disease of any grade (all CIN, VIN, VaIN) caused by HPV types 31, 33, 45, 52, 58 (3 cases in the group that received V503 vs. 103 cases in the group that received GARDASIL).
- 96.0 percent efficacy (95% CI; 94.4, 97.2) against six-month persistent HPV infection with HPV types 31, 33, 45, 52, 58 (35 cases in the group that received V503 vs. 810 cases in the group that received GARDASIL).
Because GARDASIL does not contain the five additional HPV types in V503, cases of disease caused by these five types in the study group that received GARDASIL were expected.