Bavarian Nordic Initiates Pivotal Phase 3 Trial of PROSTVAC Prostate Cancer Immunotherapy
Bavarian Nordic A/S announced that its subsidiary, BN ImmunoTherapeutics has initiated the pivotal Phase 3 trial of PROSTVAC® for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The trial is being conducted under a Special Protocol Assessment agreement with the FDA.
The first site in the U.S. has opened for enrolment of patients into the study, with a number of other sites and countries to follow soon.
"The trial represents the first-ever Phase 3 study in the history of Bavarian Nordic, and we are extremely proud to have achieved this significant milestone in our cancer vaccine division in our efforts to advance novel vaccines for the treatment of cancer," stated Anders Hedegaard, President & CEO of Bavarian Nordic. "We are encouraged by the results we have seen to date with PROSTVAC® and hope that this product may provide a more effective and convenient therapy for patients with prostate cancer."
PROSTVAC® is an "off-the-shelf" therapeutic vaccine candidate that has the potential to extend the lives of people with advanced prostate cancer. Administered subcutaneously, it induces a specific, targeted immune response that attacks prostate cancer cells.
The single global, randomized, double-blind, placebo-controlled Phase 3 study is based on the promising findings from a previous randomized, placebo-controlled Phase 2 trial of the vaccine in 125 patients with advanced prostate cancer and is expected to enrol about 1,200 patients in three study arms. Patients in the two active study arms will receive either PROSTVAC® alone or PROSTVAC® with adjuvant doses of GM-CSF. Patients who have metastatic disease and have failed hormone therapy will be eligible to enrol in the study. The primary endpoint is overall survival (OS). For the study outcome to be positive, either one or both of the treatment arms must be superior to placebo. About 300 clinical trial centers in more than 20 countries are expected to participate in the trial. Patient enrolment in the trial is expected to take up to twenty-four months.
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