BioNTech gotistobart reaches 18.5-month median survival

• BioNTech (NASDAQ:BNTX) and OncoC4 reported median overall survival of 18.5 months with gotistobart versus 10.0 months with docetaxel.
• Gotistobart produced an overall survival hazard ratio of 0.56 in the 87-patient non-pivotal Stage 1 portion of PRESERVE-003.
• The pivotal Stage 2 trial is continuing at more than 160 global sites, with overall survival as its primary endpoint.

BioNTech (NASDAQ:BNTX) and OncoC4 reported updated Phase 3 PRESERVE-003 data showing median overall survival of 18.5 months with gotistobart versus 10.0 months with docetaxel in previously treated squamous NSCLC.

The non-pivotal Stage 1 analysis included 87 patients with metastatic squamous non-small cell lung cancer whose disease had progressed following previous immunotherapy and chemotherapy.

At the July 17, 2026 data cutoff, gotistobart produced an overall survival hazard ratio of 0.56 versus docetaxel, with a nominal p-value of 0.0295 after a median follow-up of 25.4 months.

Patients were randomized to gotistobart monotherapy, with 45 receiving the experimental treatment and 42 receiving docetaxel.

Grade 3 or higher treatment-related adverse events occurred in 44.4% of patients receiving gotistobart compared with 48.8% receiving docetaxel.

BioNTech and OncoC4 described gotistobart's safety profile as manageable, while the Stage 1 survival findings remain non-pivotal and require confirmation from the ongoing pivotal portion.

The pivotal Stage 2 portion of PRESERVE-003 is underway at more than 160 sites globally, with overall survival serving as the study's primary endpoint.