Tanja Obradovic: Importance of vigilant toxicity monitoring
Tanja Obradovic shared a post on LinkedIn:
“Importance of vigilant toxicity monitoring as well as early incorporation of clear guidances on supportive care and rapid dose deescalation in the Phase I that may be especially relevant to ADC considering complexity of their mechanism of action is apparent in the example of Phase I trial of BNT326 (YL202).
Developed by MediLink Therapeutics and BioNTech SE.
BNT326 (YL202) is a HER3-directed ADC that is conjugated with a protease-cleavable linker activated in the tumor microenvironment, and pairs with a cytotoxic DNA topoisomerase I inhibitor.
In July FDA imposed partial clinical hold due to toxicity of high doses and grade 5 events.
Few days ago this hold was lifted after study changes. Dose of BNT326 (YL202) will not exceed 3mg/kg and study protocol will contain clarity and details on risk-mitigation measures such as dose delays, reductions, and modifications, as well as prophylactic measures to manage treatment-related adverse events.
Phase I trial (NCT05653752) is conducted in late stage advanced non–small cell lung cancer (NSCLC) harboring EGFR mutations or hormone receptor (HR)–positive, HER2-negative breast cancer (BC) and after changes are posted trial can be expected to open for recruitment again.”
Source: Tanja Obradovic/LinkedIn
Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.
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