Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1.
Yulia VugmeysterAna-Marija GrisicJustin J WilkinsAnja H LoosRoland HallwachsMotonobu OsadaKarthik VenkatakrishnanAkash KhandelwalPublished in: Cancer chemotherapy and pharmacology (2022)
A pragmatic model-informed approach for management of bleeding AEs was implemented in ongoing clinical trials of BA. This approach is expected to improve benefit-risk profile; however, its effectiveness will need to be evaluated based on safety data generated after implementation.