Oncology · 2 h ago
Campepepimut misses primary endpoint in randomized pancreatic cancer trial
In the open-label phase 2 AMPLIFY-7P trial, 144 patients with resected KRAS-mutated pancreatic adenocarcinoma were randomized to camupepimut or observation. The vaccine did not significantly improve the primary disease-free survival endpoint, although immune-response and subgroup analyses showed signals that investigators say will inform a confirmatory trial.
- Primary disease-free survival endpoint was not met.
- Median DFS was 23.8 versus 21.2 months.
- Subgroup and immune-response findings are exploratory.
- Overall-survival data were immature.
AMPLIFY-7P randomized 144 patients with stage I–III KRAS-mutated pancreatic adenocarcinoma, without radiographic recurrence within six months of standard locoregional treatment, to lymph node-targeted vaccine camupepimut (n=96) or standard care/observation (n=48). The primary endpoint was investigator-assessed disease-free survival (DFS). The open-label trial also assessed overall survival, safety and immune responses; overall-survival data were not mature at reporting.
The primary endpoint was not met: median DFS was 23.8 months with camupepimut and 21.2 months with observation (hazard ratio [HR] 0.85; P=0.5329). Prespecified subgroup analyses found longer DFS among patients who were ctDNA-negative (HR 0.51; P=0.0280) and those without prior radiation (HR 0.59; P=0.0221). Vaccine-induced mKRAS-specific T-cell responses were detected in 89 of 90 evaluable patients, and larger responses correlated with longer DFS in an exploratory analysis. Grade 3 or higher adverse events occurred in 10.4% and 14.6%, respectively.
The subgroup and immune-response findings are hypothesis-generating and do not override the negative primary endpoint. The authors say the results will inform a refined strategy for a confirmatory phase 3 trial; they do not establish camupepimut as a treatment option. Overall-survival data and further biomarker analyses remain outstanding.
In practice
For patients with resected KRAS-mutated pancreatic adenocarcinoma who remain recurrence-free after locoregional treatment, this randomized phase 2 trial does not support changing practice: camupepimut did not significantly improve the primary DFS endpoint. Signals in ctDNA-negative and no-prior-radiation subgroups, and correlations between T-cell response and DFS, are exploratory and require confirmation. Overall-survival data were immature, and the authors describe the findings as informing a future phase 3 strategy rather than establishing clinical benefit.
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Nature Medicine: Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.