PDS Biotechnology Corporation announced promising clinical trial results for a triple combination therapy targeting HPV-associated cancers, published in JAMA Oncology. The therapy combines Versamune® HPV, PDS01ADC (an IL-12 fused antibody-drug conjugate), and a PD-L1 immune checkpoint inhibitor. The trial involved patients with recurrent or metastatic HPV-positive anal, cervical, head and neck, penile, vaginal, and vulvar cancers.
These findings are potentially transformative for the treatment of HPV-associated cancers, particularly for recurrent or metastatic forms where current treatment options are limited and prognoses are often poor. The demonstrated efficacy in HPV16-positive patients is especially noteworthy given the prevalence of this HPV type in several cancers, including a growing number of head and neck cancers. This opens the door to significantly improved outcomes for patients with these challenging cancers.
In patients who had not received prior checkpoint inhibitors, the overall response rate was 35.7%, with a notable 75% in HPV16-positive patients. Median overall survival for this group reached 42.4 months, while survival for HPV16-positive patients was not yet reached, substantially exceeding historical data. For patients with prior checkpoint inhibitor treatment, the overall response rate was 16.7%, increasing to 62.5% in HPV16-positive patients receiving the higher dose of PDS01ADC. Median overall survival in this group was 15.8 months (17 months for HPV16-positive), again, outperforming historical results. While grade 3 and 4 adverse events were observed in 52% of patients, these were correlated with the dose of PDS01ADC and the PD-L1 inhibitor, with no treatment-related deaths reported.
The positive data from this study reinforces the potential of Versamune® HPV as a targeted immunotherapy, particularly when combined with PDS01ADC. These results support PDS Biotech’s upcoming Phase 3 trial of Versamune® HPV combined with pembrolizumab for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma. This research may pave the way for new and more effective treatment options for HPV-related cancers, offering hope for improved survival and quality of life for patients.
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.
