BioNTech gotistobart data showed median overall survival of 18.5 months compared with 10.0 months for docetaxel chemotherapy in previously treated squamous non-small cell lung cancer. BioNTech (NASDAQ: BNTX) is developing the investigational therapy with OncoC4.
The findings came from the non-pivotal first stage of the global randomized PRESERVE-003 Phase 3 trial. The analysis included 87 patients whose cancer had progressed after prior immunotherapy and chemotherapy, with a median follow-up of 25.4 months.
BioNTech Gotistobart Data Show Significant Survival Benefit
Gotistobart is a CTLA-4-targeting immunotherapy designed to reduce regulatory T cells within tumors and restore anti-tumor immune activity. The companies described the survival improvement as statistically significant and clinically meaningful.
BioNTech publishes trial updates through its official investor news archive. Serious treatment-related adverse events of grade 3 or higher occurred in 20 of 45 gotistobart patients and 20 of 42 docetaxel patients, while the overall safety profile was described as manageable.
The pivotal second stage is continuing at more than 160 sites worldwide. Although the BioNTech gotistobart data are encouraging, the first stage was not pivotal, and regulatory conclusions will depend on the larger ongoing study and the total benefit-risk evidence.
