Clinical pharmacology strategies to accelerate the development of polatuzumab vedotin and summary of key findings.

Autor: Liao MZ; Genentech, Inc. South San Francisco, CA, United States., Lu D; Genentech, Inc. South San Francisco, CA, United States., Lu T; Genentech, Inc. South San Francisco, CA, United States., Gibiansky L; QuantPharm LLC, North Potomac, MD, United States., Deng R; Genentech, Inc. South San Francisco, CA, United States., Samineni D; Genentech, Inc. South San Francisco, CA, United States., Dere R; Genentech, Inc. South San Francisco, CA, United States., Lin A; Genentech, Inc. South San Francisco, CA, United States., Hirata J; Genentech, Inc. South San Francisco, CA, United States., Shen BQ; Genentech, Inc. South San Francisco, CA, United States., Zhang D; Genentech, Inc. South San Francisco, CA, United States., Li D; Genentech, Inc. South San Francisco, CA, United States., Li C; Genentech, Inc. South San Francisco, CA, United States., Miles D; Genentech, Inc. South San Francisco, CA, United States. Electronic address: miles.dale@gene.com.
Jazyk: angličtina
Zdroj: Advanced drug delivery reviews [Adv Drug Deliv Rev] 2024 Apr; Vol. 207, pp. 115193. Date of Electronic Publication: 2024 Feb 03.
DOI: 10.1016/j.addr.2024.115193
Abstrakt: 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 clinical data for polatuzumab vedotin, published clinical data for brentuximab vedotin, a similar antibody-drug conjugate, and physiologically based pharmacokinetic and population pharmacokinetic modeling approaches. We review strategies and model-informed outcomes that contributed to regulatory approval of polatuzumab vedotin plus bendamustine and rituximab in R/R DLBCL. These strategies made polatuzumab vedotin available to patients earlier than previously possible; depending on the strength of available data and the regulatory/competitive environment, they may also prove useful in accelerating the development of other agents.
Competing Interests: Declaration of Competing Interest Michael Z. Liao, Dan Lu, Tong Lu, Divya Samineni, Randall Dere, Andy Lin, Jamie Hirata, Ben-Quan Shen, Donglu Zhang, Dongwei Li, Chunze Li and Dale Miles were employees of Genentech, Inc. and held F. Hoffmann-La Roche Ltd. Stock/stock options at the time this work was performed. Leonid Gibiansky and Rong Deng are paid consultants for Genentech, Inc.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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