PDS Biotech Updates VERSATILE-002 Phase 2 Results at ESMO 2024

PDS Biotechnology Corporation, a company specializing in immunotherapy, has shared significant updates from its VERSATILE-002 trial. This trial focuses on evaluating the efficacy of Versamune® HPV, in combination with KEYTRUDA® (pembrolizumab), as a first-line treatment for patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The results were presented on September 14, 2024, at the European Society for Medical Oncology (ESMO) Congress held in Barcelona, Spain.

The VERSATILE-002 trial, a single-arm Phase 2 study, completed its enrollment with 53 patients. As of the most recent data cut on May 17, 2024, the combination therapy of Versamune® HPV and pembrolizumab continued to show promising results and was well tolerated among the study participants. Of the 53 patients enrolled, 10 are still undergoing treatment, and 27 patients continue to be monitored for survival outcomes. The median follow-up duration for these patients is 16 months.

The data revealed several encouraging metrics:
- The Median Overall Survival (mOS) for patients was reported to be 30 months, with a lower 95% confidence interval of 19.7 months. This is a substantial improvement compared to the published mOS for pembrolizumab alone, which ranges from 12 to 18 months.
- The Objective Response Rate (ORR) was observed to be 36% (19 out of 53 patients), which is notably higher than the published ORR for pembrolizumab monotherapy, typically between 19% and 25%.
- The Disease Control Rate (DCR) stood at 77%, with 41 of the 53 patients showing disease stabilization or response.
- Remarkably, 21% of the patients experienced significant tumor shrinkage ranging from 90% to 100%, and 9% of the patients achieved a complete response.
- Treatment-related adverse events of Grade 3 or higher were reported in 9 patients, with 8 experiencing Grade 3 events and 1 experiencing a Grade 4 event.

Dr. Jared Weiss, the principal investigator of the VERSATILE-002 trial and a prominent oncologist at the University of North Carolina, emphasized the clinical activity and durability of the response from the combination therapy. He highlighted the potential of Versamune® HPV plus pembrolizumab in enhancing survival rates for patients with HPV16-positive HNSCC.

Looking forward, PDS Biotechnology is planning a global, randomized Phase 3 clinical trial, VERSATILE-003. This trial aims to compare the combination of Versamune® HPV plus pembrolizumab against pembrolizumab alone as a first-line treatment for patients with HPV16-positive R/M HNSCC. The trial is anticipated to commence this year.

Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech, expressed optimism over the maturing data, suggesting that the immune response induced by Versamune® HPV is durable. He noted that the combination therapy has shown promising patient survival rates and clinical responses, along with manageable tolerability. These findings bolster the belief in its potential to become the first HPV-targeted immunotherapy for HNSCC and a significant advancement for the increasing number of patients with HPV16-positive HNSCC.

Additionally, Versamune® HPV has received Fast Track designation from the FDA, further underscoring its potential impact in the field of cancer immunotherapy.

PDS Biotechnology continues to focus on advancing its pipeline with Versamune® HPV and other innovative treatments, aiming to bring new hope to patients with challenging forms of cancer.