PDS Biotech reports mOS of 42.4 months in ICI-naïve patients in JAMA Oncology

PDS Biotechnology Corp

Median overall survival 42.4 months in ICI-naïve patients vs. historical 7-12 months; for HPV16+ ICI-naïve, mOS not yet reached.
Confirmed ORR of 75% by irRECIST in HPV16+ ICI-naïve patients vs. historical 12-24%.
Median OS 17 months in ICI-resistant HPV16+ patients vs. historical 3-4 months; ORR 62.5% at high PDS01ADC dose.
Grade 3/4 treatment-related adverse events in 52% of patients; no treatment-related deaths.
Phase 3 VERSATILE-003 trial of Versamune HPV + pembrolizumab in head and neck cancer expected to start next month.

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