BioNTech SE (BNTX) Form 6-K — Sep 14, 2026
BioNTech SE and OncoC4 announced the first median overall survival data from stage 1 of the global randomized PRESERVE-003 Phase 3 trial, showing gotistobart (BNT316/ONC-392) achieved a median OS of 18.5 months versus 10.0 months with standard-of-care docetaxel in previously treated squamous non-small cell lung cancer patients — nearly doubling median survival. The data, presented at the IASLC 2026 World Conference on Lung Cancer, come from 87 randomized patients with a median follow-up of 25.4 months and show a hazard ratio of 0.56 with a nominal p-value of 0.0295.
Key figures
- Data cutoff
- July 17, 2026
- Hazard ratio
- 0.56
- Nominal p value
- 0.0295
- Docetaxel dosing
- 75 mg/m2
- Gotistobart dosing
- 6 mg/kg with two 10 mg/kg loading doses
- Patients randomized
- 87
- Pivotal stage sites
- more than 160 sites globally
- Docetaxel arm patients
- 42
- Median follow up months
- 25.4
- Gotistobart arm patients
- 45
- Median os docetaxel months
- 10
- Median os gotistobart months
- 18.5
- Grade3plus trae docetaxel pct
- 48.8
- Grade3plus trae gotistobart pct
- 44.4
- Squamous nsclc median os us months
- 11
- Squamous nsclc 5yr relative survival pct
- 15
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.