Gotistobart
- Generic Name
- Gotistobart
FDA Lifts Partial Hold on BioNTech and OncoC4's BNT316 Trial for Squamous NSCLC
• The FDA has lifted the partial clinical hold on the Phase 3 PresERVE-003 trial evaluating BNT316 (gotistobart) in metastatic non-small cell lung cancer (NSCLC).
• Enrollment will continue solely for patients with squamous NSCLC, following alignment with the FDA based on available trial data.
• BNT316 (ONC-392) is a next-generation anti-CTLA-4 antibody being developed by BioNTech and OncoC4, designed to enhance anti-tumor activity while preserving CTLA-4 recycling.
• BNT316 is also being evaluated in Phase 2 and Phase 1/2 trials for ovarian cancer, metastatic castration-resistant prostate cancer and multiple solid tumors.
FDA Places Partial Clinical Hold on BioNTech and OncoC4's Gotistobart Phase III NSCLC Trial
• The FDA has placed a partial clinical hold on the Phase III PRESERVE-003 trial of BioNTech and OncoC4's gotistobart due to varying results in NSCLC patient populations.
• The trial is evaluating gotistobart in metastatic non-small cell lung cancer (NSCLC) patients who have progressed after PD-(L)1-inhibitor treatment.
• BioNTech and OncoC4 have paused new patient enrollment but will continue treatment for those already enrolled in the PRESERVE-003 trial.
• The partial hold does not affect other trials of gotistobart in ovarian cancer, prostate cancer, and advanced solid tumors.
Drug Development Updates
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