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Rilimogene galvacirepvec (PROSTVAC-V) is a recombinant vaccinia virus-based cancer immunotherapy developed by the National Cancer Institute (NCI) in collaboration with Bavarian Nordic. It is designed to treat prostate cancer by inducing a targeted immune response against cells expressing prostate-specific antigen (PSA). The viral vector encodes the human PSA gene along with three costimulatory molecule transgenes—B7.1 (CD80), ICAM-1 (CD54), and LFA-3 (CD58)—collectively referred to as TRICOM. These molecules enhance the activation of T-cells by improving antigen presentation and signaling. In clinical practice, it is typically used as the 'prime' component of a heterologous prime-boost regimen, followed by 'boost' doses of rilimogene glafolivec (PROSTVAC-F), a fowlpox virus-based vector. While Phase II studies showed a significant overall survival benefit in patients with metastatic castration-resistant prostate cancer (mCRPC), the pivotal Phase III PROSPECT trial failed to meet its primary endpoint of improving overall survival compared to placebo.
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