BioNTech reports longer survival in exploratory lung-cancer trial stage

BioNTech ($BNTX) and OncoC4 reported updated results for gotistobart in previously treated advanced squamous non-small cell lung cancer. Median overall survival reached 18.5 months versus 10 months with docetaxel in the non-pivotal first stage of the global Phase 3 PRESERVE-003 study. The analysis involved 87 patients and produced a death hazard ratio of 0.56, with a nominal p-value of 0.0295.

The companies are continuing the separate pivotal stage, so the findings should not be presented as a completed confirmatory Phase 3 success. Reported grade 3 or higher treatment-related adverse events occurred in 44.4% of gotistobart recipients versus 48.8% with docetaxel. The update strengthens the development rationale but does not establish regulatory approval or guaranteed benefit for every patient.

Sources:

• BioNTech and OncoC4 — updated trial results