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Prostvac
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) is a cancer immunotherapy candidate in clinical development by Bavarian Nordic for the treatment of metastatic castration-resistant prostate cancer (mCRPC). PROSTVAC is designed to enable the immune system to recognize and attack prostate cancer cells by triggering a specific and targeted T cell immune response to cancer cells that express the tumor-associated antigen prostate-specific antigen (PSA).
PROSTVAC utilizes recombinant poxviruses to express PSA, along with 3 immune-enhancing costimulatory molecules collectively designated as TRICOM (LFA-3, ICAM-1, and B7.1).〔(【引用サイトリンク】 title=Survival Benefit Propels Prostate Cancer Vaccine to Phase III Trial )〕 Treatment is initiated by subcutaneous administration of a priming dose of vaccinia encoding PSA-TRICOM, followed by 6 subsequent boosting doses of fowlpox encoding the same PSA-TRICOM cassette. Using this heterologous prime-boost dosing regimen, the immune system becomes focused on inducing PSA-specific T cell responses, designed to kill tumor cells expressing PSA.
== Clinical development ==
PROSTVAC is being developed in partnership with the National Cancer Institute under a formal Collaborative Research and Development Agreement and has been the subject of multiple ongoing and completed clinical studies, including the global Phase 3 PROSPECT study underway in patients with asymptomatic or minimally symptomatic metastatic prostate cancer (mCRPC).〔(【引用サイトリンク】title=A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect) )〕 This Phase 3 study is designed to validate positive clinical data from a randomized, controlled, double-blind Phase 2 clinical trial that enrolled 125 minimally symptomatic mCRPC patients. The study’s secondary endpoint demonstrated that patients who received PROSTVAC had a median overall survival that was 8.5 months longer than the control group (25.1 versus 16.6 months) and a 44% reduction in the risk of death (stratified log-rank P=.0061). PROSTVAC was generally well tolerated, with the most common side effects including injection site reactions, fever, fatigue, and nausea.
Based on non-clinical data supporting the scientific rationale for combination therapy with PROSTVAC, additional clinical trials are underway to evaluate the potential clinical benefit of combining PROSTVAC with different treatment modalities such as hormonal therapies (e.g. androgen inhibitors), radiopharmaceuticals and immune checkpoint inhibitors in the treatment of prostate cancer.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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