Date: 2012-10-01
Type of information: Initiation of preclinical development
phase: 2
Announcement: preliminary results presented at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna
(http://abstracts.webges.com/myitinerary/publication-3526.html?congress=esmo2012#)
Company: Bavarian Nordic (Denmark)
Product: CV301 (CEA/MUC-1/TRICOM)
Action
mechanism: CV301 (CEA/MUC-1/TRICOM) is an immunotherapy product candidate. CV-301 originates from the same poxvirus technology platform as PROSTVAC®, the Company's lead product candidate. While PROSTVAC® incorporates a single antigen overexpressed in prostate cancer (PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are overexpressed in other major cancers, including breast, lung, and ovarian, which makes CV-301 potentially applicable in various cancers.
Disease: metastatic breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The Phase 2 study enrolled 48 patients with metastatic breast cancer to receive CV-301 in combination with docetaxel or docetaxel alone. Enrolment completed in February 2012 (CV-301, n=25; control, n=23) and 5 patients remained on study at the time of the analysis (2 in the CV-301 group, 3 in the control). The primary study endpoint was PFS, while secondary endpoints included overall survival and immunologic correlative studies. Demographics were well matched and toxicity was similar in both arms. Immune analysis and correlation to patient clinical outcomes is ongoing.
Latest
news: Bavarian Nordic has announced preliminary results from a randomized, open-label, multi-center Phase 2 study of CV-301 (CEA/MUC-1/TRICOM), an immunotherapy product candidate, in combination with docetaxel versus docetaxel alone for the treatment of metastatic breast cancer.
A preliminary analysis of the study showed progression-free survival (PFS) of 6.6 months in the CV-301 group versus 3.8 months among those receiving docetaxel alone. The clear separation of the curves indicates potential benefit. Because of its size the study was not designed to reach statistical significance. Accordingly, the p-value of (p=0.12) is considered to be a successful outcome, even though it does not meet criteria for statistical significance.
As previously announced, final study data are expected during fourth quarter 2012, whereupon Bavarian Nordic will determine its future development strategy for CV-301.
