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 reported the first median overall survival data from stage 1 of the Phase 3 PRESERVE-003 trial: gotistobart monotherapy achieved 18.5 months median OS versus 10.0 months for standard-of-care docetaxel in previously treated squamous NSCLC (HR 0.56; nominal p=0.0295), nearly doubling survival. The readout covered 87 randomized patients with a July 17, 2026 data cut-off and 25.4 months median follow-up, with comparable safety between arms — grade ≥3 treatment-related adverse events occurred in 44.4% of gotistobart patients versus 48.8% on docetaxel.
Key figures
- Drug Name
- gotistobart (BNT316/ONC-392)
- Phase Of Trial
- Phase 3 (non-pivotal stage 1)
- Data cutoff
- July 17, 2026
- Hazard ratio
- 0.56
- Docetaxel arm n
- 42
- Nominal p value
- 0.0295
- Gotistobart arm n
- 45
- Patients randomized
- 87
- Pivotal stage2 sites
- more than 160
- Median followup months
- 25.4
- Median os months docetaxel
- 10
- Median os months gotistobart
- 18.5
- Grade3plus trae docetaxel pct
- 48.8
- Grade3plus trae gotistobart pct
- 44.4
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