NONMEM Users Network Archive

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QSP/oncology webinar

From: Rebecca Baillie <rbaillie>
Date: Wed, 23 Jan 2019 06:37:34 +0000

Enhancing Phase I Clinical Decision Making Through QSP Modeling:
A Case Study of Mosunetuzumab in Relapsed/Refractory Non-Hodgkin's Lymphoma

Chi-Chung Li, Ph.D., Senior Scientist,
and Iraq Hosseini, Ph.D., Scientist

Wednesday, Jan 23, 2019, 12:00 to 1:00 pm EST

Register at

T cell-engaging bispecific antibodies (T-BsAb) are becoming important molec=
ular entities in the development of immune-oncology agents. The promises in=
 clinical efficacy with the potent mechanism of action comes with the consi=
deration to mitigate potential acute toxicity concerns, driven by the syste=
mic cytokine release following T cell activation.

To aid in the clinical development and maximize the potential therapeutic b=
enefits of mosunetuzumab, an anti-CD20/CD3 T-BsAb, a QSP model was built ba=
sed on preclinical and literature data and used to simulate and compare the=
 systemic cytokine profiles following various dosing regimens of mosunetuzu=
mab. Results indicate that a step-fractionated dosing regimen may mitigate =
the peak cytokine release levels and thereby allowing further dose escalati=
on of mosunetuzumab in Phase I development.

The QSP modeling efforts enhanced the design rationale of the Phase 1 clini=
cal studies and was used to enable a successful regulatory interaction with=
 the FDA on protocol amendments. The presentation will touch on factors tha=
t are important for the successful clinical impact of modeling by focusing =
on the appropriate clinical questions and context.

Received on Wed Jan 23 2019 - 01:37:34 EST

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