Bad omens for BioNTech & Roche’s neoantigen project
The omens don’t look good for a study of BioNTech and Roche’s personalised neoantigen candidate autogene cevumeran, in adjuvant colorectal cancer. BioNTech disclosed in its third-quarter report that, at its first interim analysis, the phase 2 BNT122-01 trial in this setting had crossed the boundary for futility, suggesting that it had failed. However, the group added that the data were “not yet mature enough to draw reliable conclusions about efficacy”, so the trial, which is comparing auto-ran to watchful waiting after surgery and chemo, will remain blinded and continue to final analysis. The next update is due in early 2026; results had once been expected in 2024. In better news for auto-ran, the Roche-sponsored Imcode-004 study in adjuvant muscle-invasive bladder cancer is now enrolling again after being placed on hold in July following an undisclosed “safety event”. Another phase 2, Imcode-003 in adjuvant pancreatic ductal adenocarcinoma, is ongoing. The partners have been shifting to adjuvant settings following auto-ran’s failure in first-line melanoma. Meanwhile, BioNTech is facing a delay for another project, the DualityBio-partnered HER2 ADC trastuzumab pamirtecan (BNT323): a US filing in second-line endometrial cancer, based on a phase 1/2 study, is now expected in 2026, from 2025 previously.
Key trials of BioNTech/Roche’s autogene cevumeran
| Trial | Setting | Sponsor | Regimen | Primary endpoint | Note |
|---|---|---|---|---|---|
| BNT122-01 | Adjuvant colorectal cancer | BioNTech | Vs watchful waiting | DFS | First interim analysis reported Nov 2025: crossed futility boundary, but “data not mature enough to draw reliable conclusions about efficacy”; trial continues; next update early 2026 |
| Imcode-003 | Adjuvant PDAC | Roche | + Tecentriq + chemo, vs chemo | DFS | “Recruitment ongoing”; completes Jan 2031 (from Dec 2029) |
| Imcode-004 | Adjuvant MIUC | Roche | + Opdivo, vs Opdivo | Investigator-assessed DFS | “Recruitment ongoing” (was put on hold Jul 2025 after “safety event”); completes Nov 2028 |
| Imcode-001 | 1st-line melanoma | Roche | + Keytruda, vs Keytruda | PFS | Fail, as per BioNTech’s Q4 2024 presentation |
| GO41836 | Adjuvant NSCLC | Roche | + Tecentriq, vs Tecentriq | DFS | Withdrawn (“accrual timelines”) |
Notes: all ph2 trials; DFS=disease-free survival; MIUC=muscle-invasive urothelial carcinoma; PDAC=pancreatic ductal adenocarcinoma; PFS=progression-free survival. Source: OncologyPipeline, clinicaltrials.gov & company presentation.
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