What are the limitations of the Saltikva Phase 2 evidence?

The study used a design that is standard for Phase 2 trials in metastatic pancreatic cancer: an open-label, single-arm study comparing results with historical controls (40 patients treated with FOLFIRINOX at the same site in 2016–2020) rather than a concurrent randomized control group. Patients were enrolled on the study's standard eligibility criteria and were not selected by tumor mutation or any other biomarker. The headline survival figures come from the 20 patients who received more than five doses, as explained in the question on why the headline analysis uses those patients. In that group, progression-free survival improved significantly (HR 0.30, p<0.001). Overall survival was p=0.063 at the published cutoff and is p<0.05 at the latest data recording (October 2026), with one patient still alive. 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 ↗). 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 did not confirm tumor colonization or local IL-2 release in patients. A randomized Phase 3 is planned to confirm the results.