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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
29 enrolled.
Median not reached at 3.2 years
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Recurrence-free survival by vaccine response (exploratory) | Vaccine responders | 8 | Median not reached at 3.2 years | - | 0.007 | link |
| Non-responders | 8 | 13.4 months |
Shares Vinod P. Balachandran, A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC, Autogene cevumeran, BioNTech.
Shares Vinod P. Balachandran, Autogene cevumeran, BioNTech, Personalised neoantigen (mRNA) vaccines.
Shares Autogene cevumeran, BioNTech, Personalised neoantigen (mRNA) vaccines, Minimal / molecular residual disease (MRD).
Shares Autogene cevumeran, BioNTech, Personalised neoantigen (mRNA) vaccines, Roche / Genentech.
Shares Vinod P. Balachandran, Personalised neoantigen (mRNA) vaccines, Memorial Sloan Kettering Cancer Center, Pancreatic ductal adenocarcinoma.
Shares Autogene cevumeran, BioNTech, Personalised neoantigen (mRNA) vaccines, Pancreatic ductal adenocarcinoma.
Shares Autogene cevumeran, Personalised neoantigen (mRNA) vaccines, Pancreatic ductal adenocarcinoma, Immune checkpoint inhibitors.
Shares BioNTech, FOLFIRINOX / mFOLFIRINOX, Pancreatic ductal adenocarcinoma.