Abstract LB-164: Treatment of advanced stage colorectal cancer with ETBX-011 immunotherapeutic.
Gabitzsch, ES; Morse, MA; Lyerly, HK; Jones, F
Published in: Cancer Research
In this Phase 1/2a non-randomized study, 32 patients having advanced stage metastatic colorectal cancer (mCRC) were treated with a novel immunotherapeutic, ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)). The trial included increasing doses of the agent and was found to be safe and well-tolerated at all doses assessed. There were no dropouts or treatments stopped due to adverse effects. Specific anti-CEA immune responses were observed in the majority of patients after they were treated three times over 6 weeks by subcutaneous injections of ETBX-011. Long-term follow-up in some of the patients reveled that the CEA directed immune responses persisted for up to 6-9 months after treatment and median overall-survival was 11 months. These results demonstrate that in mCRC patients the ETBX-011 immunotherapeutic generated significant CMI responses to the tolerized tumor antigen CEA. mCRC patients treated with ETBX-11 may experience extension of life and we are preparing to initiate a randomized, multicenter Phase 2b trial to further evaluate the clinical benefit.Citation Format: Elizabeth S. Gabitzsch, Michael A. Morse, H. Kim Lyerly, Frank Jones. Treatment of advanced stage colorectal cancer with ETBX-011 immunotherapeutic. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr LB-164. doi:10.1158/1538-7445.AM2013-LB-164Note: This abstract was not presented at the AACR Annual Meeting 2013 because the presenter was unable to attend.