BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients
BioNTech and OncoC4 announced first median overall survival data from the non-pivotal stage 1 of the PRESERVE-003 Phase 3 trial, showing gotistobart monotherapy nearly doubled median OS to 18.5 months versus 10.0 months for standard-of-care docetaxel in previously treated squamous NSCLC patients (HR 0.56, nominal p-value 0.0295). The open-label trial randomized 87 patients with a median follow-up of 25.4 months at the July 17, 2026 data cut-off. Safety remained manageable and comparable to chemotherapy, with Grade ≥3 treatment-related adverse events in 44.4% of gotistobart patients versus 48.8% on docetaxel. Data were presented at the IASLC 2026 World Conference on Lung Cancer.
Key figures
- Drug Name
- gotistobart (BNT316/ONC-392)
- Phase Of Trial
- Phase 3 (PRESERVE-003), non-pivotal stage 1
- Data cutoff
- July 17, 2026
- Hazard ratio
- 0.56
- Docetaxel arm n
- 42
- P value nominal
- 0.0295
- Gotistobart arm n
- 45
- Patients randomized
- 87
- Pivotal stage2 sites
- more than 160 globally
- Median followup months
- 25.4
- Grade3plus trae docetaxel
- 48.8% (20/42)
- Median os docetaxel months
- 10
- Grade3plus trae gotistobart
- 44.4% (20/45)
- Median os gotistobart months
- 18.5
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