# Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)

Source: https://onco.cc/trials/autogene-cevumeran-phase-1/  
OnCo record `autogene-cevumeran-phase-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

This is the small New York trial behind the excitement about personalised mRNA cancer vaccines: half of the 16 patients vaccinated after pancreatic surgery made strong T cells against their own tumour mutations, and those responders had far fewer relapses after more than three years, with vaccine-induced T cells predicted to last for years.

## Summary

Sixteen patients were treated with atezolizumab and autogene cevumeran and 15 went on to modified FOLFIRINOX; vaccines were manufactured in real time from the resected tumours and given within three days of benchmarked times. Eight of 16 mounted high-magnitude neoantigen-specific T cells (up to 10 percent of blood T cells), half against more than one neoantigen. At 18 months median recurrence-free survival was not reached in responders against 13.4 months in non-responders (p 0.003; Nature 2023), and at a 3.2-year median follow-up the difference held (median not reached against 13.4 months; p 0.007), with vaccine-induced CD8 T cell clones estimated to live 7.7 years on average, 86 percent of clones per patient persisting at about three years, and recurrent tumours pruned of the vaccine-targeted clones (Nature 2025). Responders and non-responders had mounted equivalent immunity to a concurrent SARS-CoV-2 vaccine, arguing against a fitness confounder. The registry (NCT04161755) lists 29 participants, active but no longer recruiting, primary completion November 2026. The randomised phase 2 IMCODE003 (260 patients, adjuvant autogene cevumeran with atezolizumab and modified FOLFIRINOX against chemotherapy alone, eight UK sites) will test whether this translates into fewer relapses.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Also known as: Rojas 2023; BNT122 pancreatic phase 1; RO7198457 pancreatic phase 1
- Registry id: NCT04161755
- Phase: 1
- Setting: Surgically resected pancreatic ductal adenocarcinoma: atezolizumab, then a personalised mRNA neoantigen vaccine made from each patient's tumour (up to 20 neoantigens), then modified FOLFIRINOX, a single-arm phase 1 with toxicity as the primary endpoint
- Sponsor: Memorial Sloan Kettering Cancer Center, with Genentech and BioNTech
- Enrolled: 29
- Result: Vaccine-induced T cells in 8 of 16 patients; median recurrence-free survival not reached in responders against 13.4 months in non-responders (p 0.003 at 18 months; p 0.007 at 3.2 years).
- Outcomes: Recurrence-free survival by vaccine response (exploratory): Vaccine responders vs Non-responders 13.4 months

## Sources

- ClinicalTrials.gov NCT04161755: https://clinicaltrials.gov/study/NCT04161755
- Rojas et al., personalised RNA neoantigen vaccines stimulate T cells in pancreatic cancer (Nature 2023): https://doi.org/10.1038/s41586-023-06063-y
- Sethna et al., RNA neoantigen vaccines prime long-lived CD8 T cells in pancreatic cancer (Nature 2025): https://doi.org/10.1038/s41586-024-08508-4

## Connected records

- cancers: [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Personalised neoantigen (mRNA) vaccines](https://onco.cc/technologies/neoantigen-mrna-vaccine/)
- drugs: [Atezolizumab](https://onco.cc/drugs/atezolizumab/), [Autogene cevumeran](https://onco.cc/drugs/autogene-cevumeran/), [FOLFIRINOX / mFOLFIRINOX](https://onco.cc/drugs/folfirinox/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- institutions: [Memorial Sloan Kettering Cancer Center](https://onco.cc/institutions/mskcc/)
- terms: [Hot vs cold tumours](https://onco.cc/terms/cold-vs-hot/), [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/)
- trials: [A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC](https://onco.cc/trials/nct05968326/), [AMPLIFY-7P](https://onco.cc/trials/amplify-7p/), [ECLIPSE (GVAX pancreas and CRS-207)](https://onco.cc/trials/eclipse/)
- people: [Vinod P. Balachandran](https://onco.cc/people/vinod-balachandran/)

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