A randomized phase 2 trial of camupepimut in treated pancreatic cancer found no statistically significant advantage on its primary disease-free-survival measure. The vaccine generated target-specific T-cell responses in most evaluable participants. The comparison covered 144 people, with secondary and subgroup signals leaving the question of clinical benefit for further testing.
The pancreatic-cancer vaccine camupepimut failed to establish an advantage in the primary comparison of AMPLIFY-7P, a peer-reviewed phase 2 trial. Median disease-free survival was 23.8 months with vaccination against 21.2 months in the observation group. Statistical testing gave p = 0.5329 and a hazard ratio of 0.85. The result concerns people whose cancer had been treated and who had no evidence of recurrence when they entered the study.[1]
Camupepimut targets altered KRAS, a protein involved in cancer growth. Its peptide components use an amphiphile structure designed to improve delivery to lymph nodes, where immune responses develop. Among 90 vaccinated participants with evaluable immune measurements, 89 developed target-specific T-cell responses. Larger responses correlated with longer disease-free survival. Those associations came from exploratory immune analyses; clinical benefit from those immune responses remains unestablished.[1]
The open-label study at 24 US centres randomly allocated 144 people: 96 received the vaccine, while 48 underwent observation. Randomization balanced lymph-node status between groups. Entry followed standard treatment by no more than 6 months. Grade 3 or higher adverse events affected 10 vaccine recipients and 7 observation participants. Subgroup signals included people without detectable tumour DNA in blood at baseline. Those comparisons and immune analyses lacked adjustment for multiple testing, limiting conclusions from the secondary findings.[1]
