Is the survival result for Saltikva statistically significant?

Yes. In the 20 patients who received more than five doses with FOLFIRINOX, including expanded-access patients, median progression-free survival was 15 vs 5.8 months in the 40 same-site historical FOLFIRINOX controls (HR 0.30, p<0.001). Median overall survival was 20.3 vs 11.56 months (HR 0.59). At the published data cutoff (March 1, 2025) the overall survival difference was p=0.063 (J Cell Immunol 2026;8(2):37–47 ↗). Because the study is still active and one patient is still alive, survival follow-up continues; at the latest data recording (October 2026) the overall survival difference is p<0.05. 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 ↗). Survival was compared with two-sided log-rank tests and Cox hazard ratios, with significance set at p<0.05. Overall survival was measured from diagnosis and progression-free survival from the start of treatment, which began within a few days of diagnosis. The study was not randomized; a randomized Phase 3 is planned to confirm the results.