Off-shore pilot breast cancer trials were performed at two sites; Nineteen patients with advanced breast cancer (12 stage IV, 7 stage III), most of whom had responded poorly, or not at all, to conventional modalities, received at least one inCVAX treatment. 3 patients withdrew prematurely due to unrelated reasons, leaving 16 evaluable patients. The independent investigators acquired IRB and government approvals prior to the trials. Biopsies and medical imaging (CT scans, dual phase PET scans, etc.) were used for the evaluation of the primary lesions and metastasis.

The primary efficacy parameter was the best overall response by the investigators’ assessments using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) was defined as disappearance or lack of qualifying metabolic activity of all target lesions. Partial response (PR) was defined as a ≥30% decrease from baseline in activity or in the sum of the longest diameter of target lesions. Progressive disease (PD) is defined as a ≥20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions. Stable disease (SD) was defined as neither sufficient reduction to qualify for PR nor sufficient increase to qualify for PD. Of the 16 breast cancer patients available for evaluation, complete response (CR) was observed in 3 patients, partial response (PR) in 7 patients and stable disease (SD) in 1 patient (Table 1).

Of the 16 patients available for evaluation, the objective response rate (CR+PR) was 62.5%, the clinical beneficial response rate (CR+PR+SD) was 68.75%, with 27% of the responders showing complete response within 12 months. Progressive disease was observed only in 31.25%, most of whom were triple negative breast cancer patients. All the local lesions irradiated by laser responded to inCVAX. In addition, most of the distant metastases of these patients responded to LIT. The diameters and activity of metastases, including lungs and brain, in several patients decreased dramatically.

While these numbers are not statistically significant, these data are promising for the efficacy of inVCAX and may be considered an indicator to the predicted response rate of a larger trial in the US. Local and systemic toxicity was graded according to National Cancer Institute Common Toxicity Criteria, version 3.0.