Clinical TrialApr 15, 2026, 08:47 AM
PDS Biotech's PDS01ADC Shows 78% ORR & >80% 2-Year Survival
AI Summary
PDS Biotechnology announced the publication of positive clinical and immunological biomarker data from Stage 1 of a Phase 2 trial for PDS01ADC in metastatic colorectal cancer. The trial, conducted in patients with MSS or pMMR mCRC, showed a 77.8% objective response rate and an approximately 85% 2-year survival rate when PDS01ADC was combined with HAIP therapy. These results significantly outperformed a parallel trial without PDS01ADC, which had a 35% ORR and ~40% 2-year survival rate, indicating a meaningful step towards effective immune-based treatments for a difficult-to-treat cancer.
Key Highlights
- PDS01ADC achieved 77.8% Objective Response Rate (ORR) vs. 35% without it.
- PDS01ADC showed ~85% 2-year survival rate vs. ~40% without it.
- Extrahepatic PFS not reached with PDS01ADC vs. 8.1 months without it.
- Trial in unresectable MSS/pMMR colorectal liver metastases (mCRC).