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