by Jon Fleetwood, Jon Fleetwood:
New patients continued to be recruited for 6 months after the futility boundary was crossed, Public European trial records show.
BioNTech has terminated a Phase 2 trial of its experimental mRNA cancer shot autogene cevumeran (BNT122) after an independent monitoring board found an imbalance in overall survival, with development partner Genentech confirming there were “more deaths in the vaccine arm.”
BioNTech co-developed the Pfizer-BioNTech COVID-19 mRNA vaccine sold as Comirnaty.
The cancer jab termination came about 10 months after the trial had already crossed a prespecified futility boundary but was allowed to continue.
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Public European trial records show that new patients continued to be recruited for roughly six months after the futility boundary was crossed, with recruitment continuing in Germany until April 28, 2026.
BioNTech has not publicly disclosed how many people died in either group.
‘More Deaths in the Vaccine Arm’
BioNTech announced August 28 that it was terminating BNT122-01, its randomized Phase 2 trial of autogene cevumeran, also known as BNT122 or RO7198457.
The company said the independent Data Safety Monitoring Board (DSMB) had reviewed the trial data and:
“identified a numerical imbalance in overall survival between treatment arms.”
The board also determined that continuing the trial was unlikely to change the efficacy outcome and recommended stopping treatment and terminating the study.
BioNTech did not say which arm had more deaths.
Genentech did.
Asked by Fierce Biotech, a Genentech spokesperson confirmed there were:
“more deaths in the vaccine arm in this specific patient population.”
The companies have not disclosed the number of deaths in either arm or the magnitude of the survival difference.
The Comparison Group Received No Experimental Treatment
The BioNTech-supplied ClinicalTrials.gov record says the trial was randomized and used parallel assignment.
Patients in the experimental arm received RO7198457 intravenously.
The comparison group underwent watchful waiting, which the registry explicitly describes as:
“Observational group (no intervention)”
BioNTech’s own announcement likewise says the trial compared the experimental mRNA treatment with watchful waiting.
The registry defines the trial’s overall-survival endpoint simply as:
“time from randomization to death from any cause.”
So the finding is straightforward: more deaths occurred among patients randomized to receive the experimental mRNA treatment than among those assigned to watchful waiting.
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