Why does the headline Saltikva analysis use only patients who received more than five doses?

Unlike chemotherapy, immunotherapies work by stimulating the immune system and need a minimum number of doses; more than five doses were needed to see sustained benefit, as with other immunotherapies (J Cell Immunol 2026). In the 20 patients with more than five doses, including expanded-access patients, median overall survival was 20.3 months (HR 0.59 vs the 40 same-site historical FOLFIRINOX controls; p=0.063 at the published data cutoff of March 1, 2025, and p<0.05 at the latest data recording (October 2026)). Patients with fewer doses met entry criteria but were not included in this efficacy analysis. Responses were read by RECIST 1.1, under which tumors on immunotherapy can appear to grow before responding. 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 ↗).