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BioNTech, OncoC4 data show gotistobart nearly doubles survival in lung cancer trial

BioNTech and OncoC4 report updated Phase 3 data showing gotistobart nearly doubled median overall survival versus chemotherapy in previously treated squamous NSCLC.

BioNTech SE and OncoC4 have released updated clinical data for gotistobart, their investigational therapy for previously treated squamous non-small cell lung cancer, showing a substantial survival advantage over standard-of-care chemotherapy.

In the Phase 3 trial, patients receiving gotistobart recorded a median overall survival of 18.5 months, compared with 10.0 months for those on chemotherapy — a result that nearly doubles the median survival figure for the comparator arm.

The companies said the pivotal Stage 2 portion of the PRESERVE-003 study is currently underway, with enrolment and treatment being conducted at more than 160 sites globally.

The findings cover patients with squamous non-small cell lung cancer who have already undergone prior treatment, a group with limited therapeutic options and generally poor outcomes. The updated data add to the evidence base for gotistobart as the programme advances through its late-stage development.

Further details of the trial and the full dataset were not disclosed in the initial announcement.