PDS Biotech announced updated data from its IMMUNOCERV Phase 2 clinical trial, revealing an 84.4% overall survival rate at 36 months for locally advanced cervical cancer patients treated with Versamune® HPV in combination with chemoradiation. The findings, presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024, highlight the potential of this immunotherapy approach in a high-risk patient population.
The IMMUNOCERV trial (NCT04580771) was an investigator-initiated study that enrolled 17 newly diagnosed patients with locally advanced cervical cancer, characterized by large tumors at least 5 cm in size. All patients received at least two doses of Versamune® HPV, with a median follow-up of 19 months.
Key Findings from the IMMUNOCERV Trial
The study showcased notable survival benefits and high response rates:
- Overall Survival: The 36-month overall survival (OS) rate was 84.4% for all patients. Notably, the eight patients who received all five planned doses of Versamune® HPV achieved a 100% OS rate at 36 months. This compares favorably to historical data indicating a 64% 36-month OS rate with chemoradiation alone in similar patient populations.
- Progression-Free Survival: The 36-month progression-free survival (PFS) rate was 74.9% for all patients. The subset of patients who received all five doses of Versamune® HPV also demonstrated a 100% PFS rate at 36 months, compared to an approximate 61% historical PFS rate with chemoradiation.
- Metabolic Response: A complete metabolic response (CMR) was observed in 88% (15/17) of patients, indicating a significant reduction in tumor activity.
- Safety Profile: Versamune® HPV was generally safe and well-tolerated, with the most common treatment-related adverse events being injection site reactions, reported in 71% of patients.
Expert Commentary
"HPV is responsible for virtually all cervical cancers and presents an opportunity for immunologic targeting," said Ann Klopp, M.D., Ph.D., Professor of Radiation Oncology and Head of the Gynecologic Section at MD Anderson. "However, there are currently no FDA-approved HPV-targeted immunotherapies to treat cervical cancer. These data suggest that further investigation is warranted into the safety and efficacy of Versamune® HPV in combination with standard of care in the treatment of locally advanced cervical cancer."
Future Directions
"We are pleased that data from the Phase 2 IMMUNOCERV trial demonstrate compelling clinical activity and a promising safety profile," said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. The company anticipates moving forward with the development of Versamune® HPV for locally advanced cervical cancer, building on these encouraging results.
