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Nov 4, 2013

Positive Phase III Results for Merck & Co.'s HPV Vaccine Candidate

  • Merck & Co. today trumpeted Phase III results for its 9-valent V503, saying the vaccine candidate prevented about 97% of cervical, vaginal, and vulvar precancers caused by five types of HPV—types 31, 33, 45, 52, and 58—while also generating immune responses to four other HPV types (6, 11, 16, and 18) that were noninferior to those generated by Gardasil.

    Merck said it plans to present detailed results from that study, called “Protocol 001,” and two other Phase III studies tomorrow at the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) Congress, during a late-breaker oral session.

    Protocol 001 evaluated efficacy, safety, and immunogenicity of V503 compared to Gardasil in some 14,000 young women ages 16–26. The primary efficacy analysis was conducted in patients 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). Results showed:

    • A 97.1% reduction in combined incidence of cervical/vulvar/vaginal disease of any grade caused by HPV types 31, 33, 45, 52, and 58. There were three such cases among the 7,099 patients receiving V503 vs. the 7,105 receiving Gardasil.
    • A 96.7% drop in combined incidence of high-grade cervical/vulvar/vaginal disease caused by HPV types 31, 33, 45, 52, and 58, based on one case in the V503 group vs. 30 in the Gardasil group.
    • 96% efficacy against six-month persistent HPV infection with types 31, 33, 45, 52, and 58, based on 35 cases in the V503 group and 810 in the Gardasil group.

    “Our investigational vaccine V503 reduced HPV-associated precancerous lesions in young women,” Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories, said in a statement. He added that Merck & Co. expects to submit a BLA for V503 to FDA “before the end of 2013.” 

    V503 sales are expected to impact those of Gardasil, marketed since 2006 as the first vaccine approved against HPV. During the first three quarters of 2013, Gardasil generated $1.438 billion in sales, up 21% from $1.189 billion during Q1-3 of 2012.



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