Michael Z Liao, Dan Lu, Tong Lu, Leonid Gibiansky, Rong Deng, Divya Samineni, Randall Dere, Andy Lin, Jamie Hirata, Ben-Quan Shen, Donglu Zhang, Dongwei Li, Chunze Li, Dale Miles
The favorable benefit-risk profile of polatuzumab vedotin, as demonstrated in a pivotal Phase Ib/II randomized study (GO29365; NCT02257567), coupled with the need for effective therapies in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), prompted the need to accelerate polatuzumab vedotin development. An integrated, fit-for-purpose clinical pharmacology package was designed to support regulatory approval. To address key clinical pharmacology questions without dedicated clinical pharmacology studies, we leveraged non-clinical and clinicaldata for polatuzumab vedotin, published clinical data for brentuximab vedotin, a similar antibody-drug conjugate, and physiologically based pharmacokinetic and population pharmacokinetic modeling approaches...
February 2, 2024: Advanced Drug Delivery Reviews