FDA Imposes Partial Hold on BioNTech/MedLink ADC Trial after Three Patient Deaths

CAR-T Digest - August 2020

17 June 2024: FDA Imposes Partial Hold on BioNTech/MedLink ADC Trial after Three Patient Deaths

The FDA halted a phase 1 trial (NCT05653752) of BNT326/YL202, a MediLink Therapeutics’ BioNTech-partnered ADC, three days after BioNTech reported 3 participant deaths due to treatment-related adverse events (TRAEs)
Two patients in the 18-patient fifth dosage cohort (4.0 mg/kg) and one patient in the three-patient seventh dosing cohort (5.5 mg/kg) died during the study of TRAEs
MediLink is required to review clinical and safety data for BNT326/YL202 to detail grade 5 adverse events observed in studies YL202-INT-101-01 and YL202-CN-201-01
Initial results for BNT326/YL202 showed an ORR of 42% at 2 mg/kg and 60% at 3 mg/kg. Future development will prioritize dose levels below 4.0 mg/kg, where a manageable safety profile and promising clinical activity were noted