Merck HPV Vax Improves on Gardasil

Merck has posted results from its Phase III efficacy study of 9-valent human papilloma virus (HPV) vaccine (V503). The study showed that V503 prevented approximately 97% 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.

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.

In the 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). Overall, V503 reduced HPV-associated precancerous lesions in young women.

The frequencies of adverse event (AE) reports were generally comparable between V503 and GARDASIL, but there was a higher frequency of injection-site AEs, including swelling, pain and erythema in the V503 group. The most frequently reported vaccine-related systemic AEs for V503 compared to Gardasil were headache, pyrexia, nausea, dizziness, and fatigue.

The company plans to submit a BLA for V503 to the FDA before the end of 2013.