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Clinical Trials

Date: 2012-06-02

Type of information: Interim results

phase: 2

Announcement: interim results

Company: Bavarian Nordic (Denmark)

Product: Prostvac® (rilimogene)

Action mechanism:

immunotherapy product/gene therapy. Prostvac® is a PSA-targeted, ready-to-use active immunotherapy for the treatment of prostate cancer. 
PROSTVAC is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement. In April 2010, PROSTVAC was granted Fast Track designation by the FDA for the treatment of men with asymptomatic or minimally symptomatic mCRPC.

Disease:

metastatic castration-resistant prostate cancer (mCRPC)

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

* On June 2, 2012, Bavarian Nordic has announced new interim data from an ongoing, Phase 2 randomized trial of the Company's Prostvac® therapeutic prostate cancer vaccine being conducted by the National Cancer Institute (NCI). This trial is evaluating Prostvac® when used in combination with Quadramet® (samarium-153 EDTMP, or Sm-153), a commercially available skeletal-targeted radiopharmaceutical. The interim data have been presented as a poster during the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. 
According to the investigators from NCI, this interim analysis suggests that the combination of Prostvac® and Sm-153 in patients with metastatic castration-resistant prostate cancer (mCRPC) is well tolerated with similar toxicity profile to Sm-153 alone. The early indication of improved time-to-tumor progression (TTP) warrants continued study accrual. This Phase 2 multi-center trial is intended to randomize 68 patients to Sm-153 alone (Arm A) or with Prostvac® (Arm B). Of 37 patients enrolled to date, 3 were not evaluable for progression-free survival (PFS). At four months, the PFS for evaluable patients in Arm A was 11.8% compared to 29.4% in Arm B. Median PFS for patients in Arm A was 60 days compared to 117 days in Arm B. The most common side effects were grade 3 or 4 thrombocytopenia occurring in 22% and 26% of treatment cycles on Arms A and B, respectively.

* On February 28, 2011,  Bavarian Nordic announced the initiation of a new multicenter, randomized Phase 2 study of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with Prostvac®. The study will compare Prostvac® followed by docetaxel (chemotherapy) versus docetaxel alone. Patients in the Prostvac® arm will receive an accelerated treatment with Prostvac® (5 immunizations over 2 months) followed by docetaxel and prednisone. The control arm will receive upfront docetaxel and prednisone. After completion of study therapy, patients are followed up every 3-6 months for 5 years. With the first patients now being enrolled, the study is anticipated to be fully enrolled with 144 patients in 2012. The primary endpoint of the study is to evaluate the overall survival. Secondary endpoints include the evaluation of prostate-specific antigen (PSA) response rates and evaluation of the association between development of PSA-specific immune responses, time to progression, and overall survival in patients treated with these regimens.

The study is being conducted by The Eastern Cooperative Oncology Group (ECOG) - one of the largest clinical cancer research organizations in the United States. Dr. Doug McNeel (University of Wisconsin) is the Principle Investigator of the study. The DCTD/NCI-sponsored1) study is being conducted under the cooperative research and development agreement (CRADA) that Bavarian Nordic has with the NCI for further development of  Prostvac®.

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