{"entity":{"id":"autogene-cevumeran-phase-1","kind":"trial","name":"Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)","aka":["Rojas 2023","BNT122 pancreatic phase 1","RO7198457 pancreatic phase 1"],"tldr":"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.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04161755","url":"https://clinicaltrials.gov/study/NCT04161755"},{"label":"Rojas et al., personalised RNA neoantigen vaccines stimulate T cells in pancreatic cancer (Nature 2023)","url":"https://doi.org/10.1038/s41586-023-06063-y"},{"label":"Sethna et al., RNA neoantigen vaccines prime long-lived CD8 T cells in pancreatic cancer (Nature 2025)","url":"https://doi.org/10.1038/s41586-024-08508-4"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["neoantigen-mrna-vaccine","checkpoint-inhibitor"],"targets":[],"drugs":["autogene-cevumeran","atezolizumab","folfirinox"],"companies":["biontech","roche-genentech"],"institutions":["mskcc"],"pathways":[],"terms":["cold-vs-hot","mrd"],"trials":["nct05968326"],"people":["vinod-balachandran"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","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).","yearReported":2023,"enrolled":29,"enrolledBasis":"registry","outcomes":[{"endpoint":"Recurrence-free survival by vaccine response (exploratory)","unit":"months","arms":[{"name":"Vaccine responders","n":8,"note":"Median not reached at 3.2 years"},{"name":"Non-responders","n":8,"value":13.4}],"p":"0.007","source":"https://doi.org/10.1038/s41586-024-08508-4"}]},"route":"/trials/autogene-cevumeran-phase-1/","neighbours":{"cancer":[{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"resectable-pdac","kind":"cancer","name":"Resectable pancreatic ductal adenocarcinoma","route":"/cancers/resectable-pdac/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"neoantigen-mrna-vaccine","kind":"technology","name":"Personalised neoantigen (mRNA) vaccines","route":"/technologies/neoantigen-mrna-vaccine/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"autogene-cevumeran","kind":"drug","name":"Autogene cevumeran","route":"/drugs/autogene-cevumeran/"},{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"}],"company":[{"id":"biontech","kind":"company","name":"BioNTech","route":"/companies/biontech/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"institution":[{"id":"mskcc","kind":"institution","name":"Memorial Sloan Kettering Cancer Center","route":"/institutions/mskcc/"}],"term":[{"id":"cold-vs-hot","kind":"term","name":"Hot vs cold tumours","route":"/terms/cold-vs-hot/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"}],"trial":[{"id":"nct05968326","kind":"trial","name":"A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC","route":"/trials/nct05968326/"},{"id":"amplify-7p","kind":"trial","name":"AMPLIFY-7P","route":"/trials/amplify-7p/"},{"id":"eclipse","kind":"trial","name":"ECLIPSE (GVAX pancreas and CRS-207)","route":"/trials/eclipse/"}],"person":[{"id":"vinod-balachandran","kind":"person","name":"Vinod P. Balachandran","route":"/people/vinod-balachandran/"}]}}