BioNTech and OncoC4 reported updated results from stage 1 of the PRESERVE-003 Phase 3 trial in previously treated metastatic squamous non-small cell lung cancer, showing gotistobart achieved a median overall survival of 18.5 months versus 10.0 months with docetaxel.
The company claims the comparison corresponded to a hazard ratio of 0.56 with a nominal p-value of 0.0295. At the data cut-off on 17 July 2026, a median follow-up of 25.4 months was recorded and 87 patients had been randomized, with 45 assigned to gotistobart and 42 to docetaxel.
Safety was described as consistent with prior reports and manageable, with grade 3 or higher treatment-related adverse events observed in 20 of 45 patients (44.4%) on gotistobart and 20 of 42 patients (48.8%) on docetaxel.
The findings, presented at the IASLC World Conference on Lung Cancer, relate to the non-pivotal stage 1 and come as the pivotal stage 2 enrolment continues at more than 160 sites.
