BioNTech and OncoC4 Announce Clinically Meaningful Overall Survival Benefit for Selective Treg Modulator Gotistobart in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer

Core Insights - BioNTech and OncoC4 presented promising data for gotistobart (BNT316/ONC-392), a Treg depletion candidate, showing significant overall survival benefits in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) compared to standard chemotherapy [1][4][5] Company Overview - BioNTech is a biopharmaceutical company focused on developing innovative therapies for cancer and other serious diseases, leveraging advanced immunotherapy techniques and a diverse oncology pipeline [9] - OncoC4 is a late clinical-stage biopharmaceutical company engaged in developing novel biologicals for cancer treatment, with a strategic collaboration with BioNTech for gotistobart [14] Clinical Trial Insights - The PRESERVE-003 trial is a two-stage Phase 3 study evaluating gotistobart as a monotherapy against standard chemotherapy in sqNSCLC patients who have progressed on prior treatments [5] - In the non-pivotal stage, 45 patients received gotistobart, while 42 received docetaxel, with a 12-month overall survival rate of 63.1% for gotistobart versus 30.3% for docetaxel [2][4] - The ongoing pivotal stage aims to enroll approximately 500 patients across multiple countries, focusing on overall survival as the primary endpoint [5] Treatment Efficacy - Gotistobart has not yet reached a median overall survival at nearly 15 months of follow-up, while docetaxel showed a median overall survival of 10 months [2][4] - The treatment with gotistobart reduced the risk of death by 54% compared to docetaxel, indicating a significant clinical advantage [2][4] Safety Profile - The safety profile of gotistobart was manageable, with 42.2% of patients experiencing grade ≥3 treatment-related adverse events compared to 48.8% in the docetaxel group [2][4] Regulatory Status - Gotistobart has received Fast Track Designation from the FDA for treating metastatic NSCLC patients whose disease progressed on prior anti-PD-(L)1 therapy, highlighting its potential as a novel treatment option [4][6]