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PDS Biotech Reports Updated Interim Results from the P-II Trial (VERSATILE-002) Results of PDS0101 + Keytruda for Head and Neck Cancer

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PDS Biotech

PDS Biotech Reports Updated Interim Results from the P-II Trial (VERSATILE-002) Results of PDS0101 + Keytruda for Head and Neck Cancer

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  • The P-II trial evaluating PDS0101 (HPV16-targeted investigational T cell-activating immunotherapy) + Keytruda. The trial is investigating 2 patient populations i.e., ICI naïve & ICI refractory
  • Interim results from the ICI naïve cohort incl. 12 & 24mos. OS rate (80% & 74%); tumor shrinkage (60%); ORR (27%); m-PFS (8.1mos.), grade 3 TRAEs (13%); grade 4 or 5 TRAE (0%); patients have CPS score of 1-19 & >20 (60% & 40%), respectively
  • ICI refractory cohort incl. 12mos. OS rate (56%); median 12mos. OS rate (17%) with no salvage CT following tumor progression on ICI; ORR (0%) suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage; grade 3 TRAE (4%); grade 4 & 5 TRAE (0%). The combination treatment will be evaluated in the P-III trial (VERSATILE-003) with an expected initiation in Q4’23

Ref: PDS Biotech | Image: PDS Biotech

Related News:- PDS Biotech to Initiate P-III Trial (VERSATILE-003) of PDS0101 + Keytruda (pembrolizumab) for Head and Neck Cancer

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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