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Investing.com -- PDS Biotechnology Corporation (NASDAQ:PDSB) stock rose 3% after the company announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial for head and neck cancer treatment.
The late-stage immunotherapy company reported a median overall survival of 39.3 months in patients with CPS ≥ 1 treated with its PDS0101 therapy in combination with Keytruda (pembrolizumab). According to the company, this significantly exceeds the best published result with standard of care pembrolizumab or pembrolizumab plus chemotherapy, which stands at 17.9 months.
The VERSATILE-002 trial evaluated the combination therapy in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer. The company enrolled 53 patients in this arm of the trial, administering PDS0101 by subcutaneous injection alongside pembrolizumab infusions.
"We believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients," said Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech. The company plans to publish the full data set later this year.
PDS Biotech is currently advancing its VERSATILE-003 Phase 3 trial, building on these results. The company noted that durable patient survival is promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, with similar results across various patient demographics and clinical characteristics.
The company highlighted that HPV16-positive head and neck squamous cell cancer represents a significant and growing unmet medical need in the US and Europe.
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