ESMO Congress 2026

Camupepimut (ELI-002) is a lymph-node-targeted, mKRAS-specific amphiphile therapeutic vaccine, whose published evidence centers on the phase 1 AMPLIFY-201 trial: 25 patients (20 pancreatic, 5 colorectal) with mKRAS minimal residual disease after locoregional treatment; no dose-limiting toxicities were observed, the RP2D was Amph-CpG-7909 10.0 mg, and mKRAS-specific T cell responses were induced in 84% (21/25) ^[1]. Final results (median follow-up 19.7 months) showed that responders above the 9.17-fold-over-baseline threshold had median RFS not reached versus 3.02 months (HR 0.12, P=0.0002), and median OS not reached versus 15.98 months (HR 0.23, P=0.0099), with antigen spreading in 67% of patients ^[2]. Reviews note that this platform traffics efficiently to lymph nodes via albumin binding, induces KRAS-specific T cell responses in most patients correlating with survival, but that all evidence comes from early-phase studies with limited patient numbers ^[4]. Large-sample precedents for adjuvant T cell vaccines in the same class have not fared well: the phase III MAGRIT trial of adjuvant MAGE-A3 vaccination in NSCLC showed no DFS benefit ^[3].

What was reported at this ESMO meeting, as a late-breaking presentation, is the randomized phase 2 AMPLIFY-7P: camupepimut (ELI-002 7P) versus observation as adjuvant therapy for resected stage II–III KRAS-mutated PDAC, 144 patients in total. The primary DFS endpoint was not met—an outcome already disclosed in June and not the new news here; median DFS was 23.8 versus 21.2 months, HR 0.85, P=0.5329, no significant improvement. The incremental information at this meeting is the subgroup data: DFS HR 0.51 in ctDNA-negative patients and 0.57 in ctDNA-positive patients, both below the overall HR of 0.85. The results were published simultaneously in Nature Medicine. Per an on-site expert post, a phase III is ongoing based on prespecified 6-month DFS data; the market view lists the phase 3 development plans as the next watch item, and shares pared earlier losses to −1.5% on the day.

Relative to prior knowledge, AMPLIFY-7P moves this platform from single-arm phase 1 ^[1][2] to a randomized controlled adjuvant setting, and the enrolled population expands from mKRAS MRD-positive patients only in phase 1 ^[1] to include both ctDNA-negative and ctDNA-positive patients. In the randomized total population, no significant DFS benefit was seen, a gap versus the RFS/OS signals observed in the phase 1 MRD-positive population ^[2]; however, the HRs in both ctDNA subgroups were lower than the overall HR, providing directional support for further development, while the stated basis for initiating the phase III in the materials is the prespecified 6-month DFS data.

On limitations: the primary endpoint was missed with P=0.5329 and the median DFS difference in the total population is limited; whether the subgroup analyses were prespecified, and the specific design of the phase III (population, endpoints, sample size) are not disclosed in these materials and await confirmation; background reviews also caution that existing evidence for this platform rests on early-phase studies with limited patient numbers ^[4], so the definitive interpretation of these randomized data awaits longer follow-up and phase 3 validation.