Methods
Madison Vaccines Incorporated (MVI) conducted a Phase II prospective, randomized controlled trial with 97 non-metastatic castration-sensitive prostate cancer (nmCSPC) patients. The study compared outcomes for a pTVG-HP vaccine with adjuvant sargramostin (experimental arm) to outcomes for sargramostin alone (control arm). Patients were classified as non-metastatic using conventional imaging. The primary endpoint was 2-year metastasis-free survival (2YMFS). AIQ technology was used to study pharmacodynamic effects in a subset of 34 patients, who had multiple PET/CT scans.
Results
The initial results for the 97 patient study showed no difference in 2YMFS between the experimental and control arms (41.8% and 42.3%, respectively, p=0.97). The AIQ TRA, however, demonstrated positive pharmacodynamic effects for the vaccine. After six months of treatment, total disease burden, measured as SUVTOTAL, decreased by 23% in the experimental group while it increased by 50% in the control arm (p=0.071). Further, while all patients were classified as non-metastatic by conventional imaging, the AIQ TRA detected lesions at the beginning of treatment in 30 of 34 patients.
Conclusion
The combination of 97 patients and 24-month monitoring failed to meet the primary endpoint of MFS. 34 patients and 6-month monitoring were sufficient to demonstrate benefit for the vaccine using the AIQ TRA. The intelligence provided by AIQ helped MVI decide to continue development of pTVG-HP asset.
Read more about how AIQ actionable intelligence on pharmacodynamic effects improves clinical studies
