PRINCETON -
'We have obtained compelling data from several Phase 2 trials in the fourth quarter of 2023, including long-term survival data from the
'By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV+ head and neck squamous cell cancer (HNSCC), we strongly believe this approach may rapidly establish our proprietary combination of PDS01ADC and Versamune HPV as a transformative oncology treatment. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. It may also significantly increase the rates of durable tumor shrinkage or overall responses,' said
With the recent long-term survival Phase 2 data from the NCI-led triple combination trial, together with favorable safety and extended survival results seen in both ICI naive and resistant patients in our VERSATILE-002 trial, PDS Biotech has decided to prioritize the triple combination in place of the VERSATILE-003 trial. This decision enables PDS Biotech to focus its resources on the drug regimen it believes has the highest potential to benefit patients with HNSCC and to drive shareholder value.
'We have had several discussions with key opinion leaders in HNSCC regarding the use of the triple combination in HNSCC. A clear unmet need is seen in HPV+ HNSCC with few agents being studied in this population due to the difficulty in treating advanced HNSCC,' said
'Despite good outcomes in many patients with HPV-related HNSCC, approximately 20% of patients will develop recurrent, incurable disease, often in young individuals in the prime of their lives. HPV-related HNSCC that progresses after standard first-line chemotherapy is a devastating, hard-to-treat cancer with no HPV-related treatment currently approved. The NCI clinical trial data show significant promise in the use of PDS01ADC in combination with Versamune HPV,' said
Clinical Strategy Update
Triple Combination Clinical Trial (PDS01ADC, Versamune HPV and KEYTRUDA)
Company in discussions with the
Previously announced data from Phase 2 NCI-led triple combination clinical trial for the treatment of recurrent/metastatic ICI naive and ICI resistant HPV16-positive cancers including head and neck, anal, cervical, vaginal and vulvar cancers support rationale: ICI naive group: 75% of patients remain alive at 36 months. The median overall survival (OS) was not reached. Published results show a 36-month survival rate of approximately 20% with ICIs. An overall response rate (ORR) of 75% and complete response of 38% were seen in patients treated with the triple combination. Published ORR of
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