Does Saltikva extend life?

In the Phase 2, patients who received more than five doses with FOLFIRINOX (n=20) had median overall survival of 20.3 months vs 11.56 months in the 40 same-site historical FOLFIRINOX controls (hazard ratio 0.59; p=0.063 at the published data cutoff of March 1, 2025, and p<0.05 at the latest data recording (October 2026)), and median progression-free survival of 15 vs 5.8 months (HR 0.30, p<0.001). In the 20 patients who received more than five doses, 70% had a partial response (95% CI 45.5–87.9%), vs a 31.6% objective response rate for FOLFIRINOX alone in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al., N Engl J Med 2011;364:1817–25 ↗), and in a post-hoc review 16 of those 20 patients (80%) progressed without new metastases (J Cell Immunol 2026;8(2):48–52 ↗). The study was not randomized; a randomized Phase 3 is planned to confirm whether Saltikva extends life.