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PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 and KEYTRUDA® in Head and Neck Cancer
14 patients in the immune checkpoint inhibitor naïve arm of VERSATILE-002 have experienced either a complete response or partial response on two consecutive
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"14 patients in the immune checkpoint inhibitor naïve arm of VERSATILE-002 have experienced either a complete response or partial response on two consecutive scans, thus constituting a confirmed objective responseEfficacy and safety continue to be monitored as additional patients have yet to undergo imaging evaluation FLORHAM PARK, N.J., June 14, 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 today the Company achieved the threshold for efficacy as per investigator assessment in Stage 2 of the VERSATILE-002 (NCT04260126) Phase 2 clinical trial investigating PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer. The achievement of full recruitment of 54 patients in the ICI naïve arm was announced in May 2023. The threshold for efficacy, as defined in the clinical protocol, was achieved when 14 out of the 54 immune checkpoint inhibitor (ICI) naïve patients enrolled achieved a confirmed objective response. Additional patients in the trial have yet to undergo imaging evaluation. Per RECIST 1.1, the standard to classify oncologic imaging outcomes in clinical trials, patients are considered to have achieved an objective response when imaging studies document tumor shrinkage of 30% or more. In VERSATILE-002, the primary endpoint requires two consecutive scans 9 to 12 weeks apart, rather than one, to be considered a confirmed objective response. Confirmation with two consecutive scans is not required to achieve an objective response in every clinical trial per RECIST 1.1. At the recent 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, we presented data showing 9 confirmed responses among 34 evaluable patients. Median progression-free survival (PFS) of 10.4 months was also presented at the 2023 ASCO Annual Meeting along with a 12-month overall survival (OS) rate of 87.1% for patients with a CPS≥1. Additional patients have been assessed since data was presented at the 2023 ASCO Annual Meeting. With these additional data, a total of 14 patients have now achieved a confirmed response to date. The achievement of this end...