PDS Biotechnology reports 77.8% ORR in Stage 1 Phase 2 PDS01ADC mCRC data
PDS Biotechnology announced positive interim Phase 2 Stage 1 data for PDS01ADC plus HAIP in MSS/pMMR colorectal liver metastases. The trial showed a 77.8% objective response rate and about 85% 24-month survival in 9 patients.
PDS Biotechnology announced publication of positive interim Phase 2 Stage 1 data showing a 77.8% objective response rate and ~85% 24-month survival with PDS01ADC added to HAIP in patients with unresectable microsatellite stable or mismatch repair-proficient colorectal liver metastases. Stage 1 enrolled 9 patients in an NCI-led, open-label Simon two-stage design trial.
Stage 1 showed 77.8% ORR at six months for PDS01ADC plus HAIP versus 35% in a parallel trial without PDS01ADC. Reported 24-month survival ~85% with PDS01ADC plus HAIP versus ~40% in the parallel study without PDS01ADC.
The data also showed extrahepatic PFS median not reached at ≥13.1 months versus 8.1 months in the parallel trial. The study was in MSS/pMMR colorectal liver metastases, a setting where traditional immune checkpoint inhibitors have failed.
The data were published in JCO Oncology Advances.