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PDS Biotech Announces Interim Data Demonstrates 12-Month Survival Rate of 87% with PDS0101 in Combination with KEYTRUDA® (pembrolizumab) for Head and Neck Cancer Patients
Interim data being presented at ASCO 2023 Annual Meeting Demonstrated median progression-free survival (PFS) of 10.4 months Demonstrated 12-month overall
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"Interim data being presented at ASCO 2023 Annual Meeting Demonstrated median progression-free survival (PFS) of 10.4 months Demonstrated 12-month overall survival (OS) rate of 87.1%A disease control rate (disease stabilization or tumor shrinkage) of 70.6%Median overall survival not yet met Company to host conference call and webcast on June 6, 2023, at 8:00 am ET FLORHAM PARK, N.J., May 25, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology 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 dat...