Bavarian Nordic Successfully Completes End of Phase II Meeting for PROSTVAC
Regulatory agencies endorse the overall Phase III plan for PROSTVAC in prostate cancer
Bavarian Nordic A/S announced that the company has received Scientific Advice from the European Medicines Agency and concluded an end of Phase II meeting with the US Food and Drug Administration (FDA) for the PROSTVAC(TM) programme. Both agencies expressed general agreement with the proposed Phase III clinical programme of PROSTVAC(TM). Based on the consolidated feedback Bavarian Nordic will proceed to assemble a clinical trial protocol and submit it to the Special Protocol Assessment (SPA) process with the FDA within a few months. The final clinical protocol will be based on the outcome of this process.
Based on the consolidated feedback, Bavarian Nordic is planning to achieve marketing approval for PROSTVAC(TM) via a single global, strongly powered clinical trial that is expected to enrol about 1,200 patients. The study will be placebo-controlled and enrol patients with minimally symptomatic, castration-resistant metastatic prostate cancer, similar to the patient population studied in the company's placebo-controlled Phase II study.
The previously conducted Phase II study was a prospective randomized, double-blind, placebo-controlled study of 125 patients with metastatic prostate cancer. Patients in the PROSTVAC(TM) group had a significantly longer median overall survival by 8.5 months compared to the control group (p=0.006). The hazard ratio estimate for overall survival from the study is 0.56 (95% CI 0.37-0.85). The study was published in Journal of Clinical Oncology.
Anders Hedegaard, President & CEO of Bavarian Nordic, said: "We are delighted with the outcome of our dialogue with both FDA and EMEA, as both agencies expressed general agreement with our clinical strategy to register PROSTVAC(TM). Although the final protocols still have to be formally agreed with both agencies, there is now a clear path to registering PROSTVAC(TM) in the US and Europe."
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