PDS Biotechnology Announces Interim Data Demonstrates 12-Month Survival Rate of 87% with PDS0101 in Combination with KEYTRUDA for Head and Neck Cancer Patients

PDS Biotechnology (NASDAQ:) Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced promising interim data from the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. The results will be featured in a poster presentation and in a head and neck cancer expert panel discussion at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2-6 in Chicago.

The presentation, titled “Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC)” (Abstract #6012), concluded that the combination was well tolerated, and the results justify a global confirmatory randomized, controlled study, VERSATILE-003, which PDS Biotech is planning to initiate this year. The study’s 48 ICI naïve participants, 94% of whom were male with a median age of 62.5, received at least one cycle of the combination arm, 56.3% received four doses, and 22.9% received five doses.

In measuring the efficacy of PDS0101 in combination with KEYTRUDA®, the abstract highlights the following interim data:

• Estimated 12-month overall survival rate was 87.1%. Published results are 36-50% with approved ICIs used alone*.
• Median progression-free survival was 10.4 months (95% CI 4.2, 15.3). Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels*.
• A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)
• Confirmed and unconfirmed objective response rate was 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients). To date these responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.
• 15/34 patients (44.1%) had stable disease.
• 9/34 patients (26.5%) had progressive disease.
• 4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE). No…