BioNTech has terminated a Phase 2 trial of autogene cevumeran (BNT122/RO7198457), its individualized mRNA cancer immunotherapy, in patients with resected, high-risk colorectal cancer following a recommendation from an independent Data Safety Monitoring Board (DSMB).
BioNTech announced on August 28, 2026, that it will terminate the BNT122-01 Phase 2 trial (NCT04486378) evaluating autogene cevumeran as adjuvant monotherapy in patients with circulating tumor DNA (ctDNA)-positive, surgically resected Stage II high-risk or Stage III colorectal cancer.
Autogene cevumeran, also known as BNT122 or RO7198457, is an individualized mRNA-based cancer immunotherapy being jointly developed by BioNTech and Genentech, a member of the Roche Group. The decision to terminate the trial was made in consultation with Genentech.
Why Did BioNTech Terminate the BNT122-01 Trial?
The decision followed the latest review of the trial by the independent DSMB.
According to BioNTech, the DSMB identified a numerical imbalance in overall survival between the treatment arms and concluded that further continuation of the trial was unlikely to change the efficacy outcome. The board therefore recommended discontinuing treatment and terminating the study.
Importantly, no new safety signals related to autogene cevumeran were identified during the review.
The development follows an earlier setback in October 2025, when the BNT122-01 study crossed its prespecified futility boundary. At that time, however, the DSMB considered the available data and follow-up insufficiently mature to draw reliable conclusions about efficacy or the study’s primary endpoint. With no safety concerns identified at that stage, the trial was allowed to continue.
What Was the BNT122-01 Phase 2 Trial?
BNT122-01 (NCT04486378) was a multicenter, open-label, randomized Phase 2 study comparing autogene cevumeran with watchful waiting in patients with ctDNA-positive colorectal cancer following surgical resection.
The study was designed to enroll approximately 327 patients with resected Stage II high-risk or Stage III colorectal cancer. Its primary endpoint was disease-free survival (DFS), while secondary objectives included overall survival and safety.
The study sought to determine whether individualized mRNA immunotherapy given as monotherapy could reduce the risk of colorectal cancer recurrence in patients with molecular evidence of residual disease after treatment.
BioNTech noted that colorectal cancer represents a particularly challenging setting for immunotherapy because it is generally considered an immunologically “cold” tumor, with a tumor microenvironment that can limit effective immune responses.
What Is Autogene Cevumeran?
Autogene cevumeran is an individualized neoantigen-specific mRNA immunotherapy designed around the molecular characteristics of an individual patient’s tumor.
The approach identifies tumor-specific neoantigens and uses an individualized mRNA treatment intended to stimulate immune responses against those targets.
The discontinued colorectal cancer study evaluated autogene cevumeran without a checkpoint inhibitor, making it an important test of whether personalized mRNA immunotherapy could work as a standalone adjuvant treatment in this high-risk population.
Commenting on the outcome, Özlem Türeci, Co-Founder and Chief Medical Officer of BioNTech, said the findings provide scientific insight into the difficulty of treating immunotherapy-insensitive tumors with immune-suppressive microenvironments.
BioNTech said it remains committed to mRNA technology as a central component of its oncology strategy, including approaches that combine mRNA cancer immunotherapies with other therapeutic modalities.
BioNTech’s Pancreatic Cancer mRNA Trial Will Continue
The termination of BNT122-01 does not affect BioNTech’s ongoing development of autogene cevumeran in pancreatic cancer.
The IMcode003 Phase 2 trial (NCT05968326), which is evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy as adjuvant therapy for pancreatic ductal adenocarcinoma, will continue as planned.
This distinction is notable because the colorectal cancer trial investigated the individualized mRNA therapy as a monotherapy, while IMcode003 uses a combination treatment strategy.
BioNTech plans to conduct a detailed analysis of the BNT122-01 data to better understand patient selection and inform the future clinical development of individualized mRNA cancer immunotherapies. The company said results from the study will be shared with the scientific and medical community at a later date.
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