What were the efficacy results for Saltikva with FOLFIRINOX in the Phase 2?

The Phase 2 reports, for Saltikva with FOLFIRINOX (J Cell Immunol 2026, Table 2 ↗): in the 20 patients with more than five doses, including expanded-access patients, median overall survival of 20.3 months vs 11.56 months in the 40 same-site historical FOLFIRINOX controls (HR 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), with a 70 percent partial response rate. Across all 25 analyzed patients, including expanded-access patients and patients who did not meet the minimum dosage criteria, median overall survival was 18.6 months (partial response rate 56 percent). The 70 percent partial response rate in the 20 patients (95% CI 45.5–87.9%) compares with 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 controls were 40 patients given FOLFIRINOX alone at the same site in 2016 to 2020. Trial eligibility required ECOG 0 or 1.