What did the Saltikva Phase 2 study find, in plain language?
Saltikva from Salspera, Inc. is investigational and not approved. Company-affiliated authors reported these median overall survival figures for Saltikva with FOLFIRINOX:
| Patient group | Patients | Median OS |
|---|---|---|
| All analyzed, including expanded-access patients and patients who did not meet the minimum dosage criteria | 25 | 18.6 months |
| More than five doses, including expanded access | 20 | 20.3 months |
| Trial patients without expanded access, including patients who did not meet the minimum dosage criteria | 21 | 13.8 months |
| Protocol-compliant trial patients with more than five doses, without expanded access | 16 | 18.6 months |
| Historical same-site controls treated with FOLFIRINOX alone, 2016–2020 | 40 | 11.56 months |
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 ↗).
There was no concurrent randomized control group. These analyses do not establish that Saltikva extends life.
The published J Cell Immunol 2026 papers state the control group sizes incorrectly (n=37 FOLFIRINOX, n=31 gemcitabine/nab-paclitaxel) and will be amended.