PDS Biotechnology Corporation announced positive clinical trial results for its lead immunotherapy candidate, Versamune® HPV, in the treatment of locally advanced cervical cancer. The trial demonstrated that combining Versamune® HPV with standard chemoradiation (CRT) led to a faster and more complete clearance of HPV16-positive cancer cells from the bloodstream compared to CRT alone. This clearance of circulating tumor DNA (ctDNA) strongly correlated with improved two-year recurrence-free survival rates.
These results are particularly promising because they demonstrate a potential for Versamune® HPV to not just treat, but potentially prevent cancer recurrence in HPV16-positive cancers. The strong correlation between ctDNA clearance and improved survival provides a compelling biomarker for tracking treatment efficacy and could potentially expedite regulatory approval pathways, like Breakthrough Therapy designation. Furthermore, these findings suggest that Versamune® HPV could be effective against other HPV16-positive cancers, such as head and neck squamous cell carcinoma (HNSCC), paving the way for broader clinical applications.
In the study of 66 patients with locally advanced cervical cancer, 100% of the patients receiving the combination therapy showed no detectable HPV16 ctDNA at 3-4 months post-treatment, compared to 50% in the CRT-only group. This translated to a significantly higher two-year recurrence-free survival rate of 93% in the combination therapy group versus 30% in the CRT-only group. Previously reported data also indicated promising 36-month overall survival rates for patients receiving Versamune® HPV in combination with CRT. A Phase 3 clinical trial for Versamune® HPV in HPV16-positive HNSCC is planned for the first quarter of 2025.
This positive data strengthens the potential of Versamune® HPV as a valuable treatment option for various HPV-related cancers. The upcoming Phase 3 trial in HNSCC will be a crucial step in further validating its efficacy and broadening its clinical reach. The results may lead to a paradigm shift in HPV-related cancer treatment, potentially offering patients a significantly improved chance of long-term survival and a reduced risk of recurrence. Further research and development will focus on exploring its potential in other HPV-driven cancers and optimizing treatment strategies to maximize patient benefits.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
