Camupepimut vaccine shows benefit in pancreatic cancer subgroup
The AMPLIFY-7P phase 2 trial found camupepimut did not improve disease-free survival overall but showed significant benefit in ctDNA-negative pancreatic cancer patients.
A lymph node-targeted vaccine for mutant KRAS-driven pancreatic cancer failed its primary endpoint but showed a significant survival benefit in a key patient subgroup. The phase 2 AMPLIFY-7P trial randomized 144 patients, with 96 receiving camupepimut and 48 assigned to standard-of-care observation, but did not meet its primary goal of improved disease-free survival in the overall population.
Camupepimut, also known as ELI-002 7P, is an amphiphile vaccine designed to target seven common KRAS mutations. In the intent-to-treat analysis, median disease-free survival was 23.8 months for the vaccine group versus 21.2 months for observation, a difference that was not statistically significant with a hazard ratio of 0.85.
Subgroup analyses reveal survival advantage
Prespecified analyses revealed the vaccine's efficacy was concentrated in patients with no detectable circulating tumor DNA after surgery and in those who had not received prior radiation therapy. For the 93 ctDNA-negative patients, median disease-free survival was not reached in the camupepimut arm compared to 21.2 months with observation.
| Subgroup | Patient Count | Camupepimut Median DFS | Observation Median DFS | Hazard Ratio | P-value |
|---|---|---|---|---|---|
| ctDNA-negative | 93 | Not reached | 21.2 months | 0.51 | 0.0280 |
| No prior radiation | 106 | 23.8 months | 10.4 months | 0.59 | 0.0221 |
Stronger mutant KRAS-specific T-cell responses were strongly linked to better outcomes. Patients who mounted a T-cell response greater than 9.17-fold over baseline saw a dramatically reduced risk of relapse or death, with a hazard ratio of 0.22.
Safety profile and tolerability
The vaccine demonstrated a manageable safety profile. Grade 3 or higher adverse events occurred in 10.4% of treated patients, which was lower than the 14.6% rate in the observation arm. Serious adverse events were reported in 6.3% of the camupepimut group versus 8.3% of the observation group. No patient withdrew from the study due to a vaccine-related adverse event.
Biological mechanism and immune response
Camupepimut successfully induced a potent immune response. Ex vivo mutant KRAS-specific T-cell responses were detected in 98.9% of evaluated patients, with a median 44.3-fold increase from baseline. These responses were durable, persisting for at least 46 weeks in 95.5% of patients. An early signal of benefit was seen at six months, with a disease-free survival rate of 75.7% for camupepimut versus 61.7% for observation.
Additional analyses provided further context. A post hoc multivariate analysis that adjusted for prognostic factors like baseline ctDNA status and CA19-9 levels showed an adjusted hazard ratio of 0.47 favoring camupepimut. The study population had a median age of 65 years and was 54.2% female. The most common KRAS mutation among treated patients was G12V, present in 40.6% of cases.
The developer, Elicio Therapeutics, plans to discuss these findings with the U.S. Food and Drug Administration to inform the design of a potential phase 3 study in adjuvant pancreatic cancer.
