Targeted immunotherapy candidate for combination treatment of prostate cancer
PROSTVAC is a prostate specific antigen (PSA)-targeted immunotherapy candidate which has been investigated in multiple clinical trials across various stages of prostate cancer.
The PROSPECT Phase 3 study, a global randomized, double-blind, placebo-controlled trial of PROSTVAC as monotherapy in 1,297 patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer, was discontinued in September 2017 after recommendation from the independent Data Monitoring Committee (DMC). Based on a preplanned, third interim analysis, the committee determined that continuation of the study was futile, and that it was unlikely to reach its primary endpoint of overall survival.
Bavarian Nordic and its partners continue to explore the potential of PROSTVAC as combination therapy in early stage prostate cancer, including exploratory studies of PROSTVAC with or without immune checkpoint inhibitors from Bristol-Myers Squibb (ipilimumab and nivolumab).
Initial results from an ongoing Phase 2 combination trial of PROSTVAC and nivolumab as neoadjuvant therapy in patients with localized prostate cancer are anticipated during 2018, which could provide evidence of a clinical benefit of the combination of PROSTVAC and checkpoint inhibitors.