On February 24, 2015 Bavarian Nordic reported that updated overall survival data from an NCI sponsored combination study of Bavarian Nordic’s active prostate cancer immunotherapy candidate PROSTVAC and ipilimumab, an immune checkpoint inhibitor will be presented at the Genitourinary Cancers Symposium in Orlando, FL on Thursday, February 26, 2015 (Press release Bavarian Nordic, FEB 24, 2015, View Source [SID:1234501841]).
30 patients with metastatic castration-resistant prostate cancer (mCRPC) were enrolled in the Phase 1 combination study. At the time of enrollment docetaxel was the only FDA-approved treatment that improved overall survival. The median predicted overall survival (OS) was 18.5 months. Patients were treated with PROSTVAC plus escalating doses of ipilimumab. The observed median OS was 31.3 months for all dose cohorts and 37.2 months for patients treated at 10 mg/kg based on updated overall survival data. Furthermore, approximately 20% of patients at 10 mg/kg remain alive at 80 months.
The senior author for the presentation as a poster is Dr. James L. Gulley, Laboratory of Tumor Immunology and Biology, National Cancer Institute at the National Institutes of Health. The presentation will take place during General Poster Session A on Thursday, February 26, 2015 from 11:30 AM – 1:00 PM EST at board H8. An abstract entitled: “Combining active immunotherapy and immune checkpoint inhibitors in prostate cancer” (Abstract #172) is also available online at View Source
Paul Chaplin, President & CEO of Bavarian Nordic, said: “The updated long-term survival data presented by our partners at NCI is further evidence of improved OS following treatment with PROSTVAC. These data represent perhaps the most compelling survival benefit seen to date in this late-stage setting, and provide a strong rationale to continue to evaluate the combination of PROSTVAC and checkpoint inhibitors in follow-on clinical studies. Given the unique product profile of PROSTVAC, with a favorable risk-benefit profile and ease of use, we see PROSTVAC as an ideal immunotherapy to combine with both approved and emerging therapies for prostate cancer and we look forward to exploring these further in the clinic.”