Lin, Lan-Hsi
Ghasemi, Mohammad
Burke, Sarah M.
Mavis, Cory K.
Nichols, Jenna R.
Torka, Pallawi
Mager, Donald E.
Hernandez-Ilizaliturri, Francisco J.
Goey, Andrew K. L. http://orcid.org/0000-0002-3824-3417
Funding for this research was provided by:
Amgen
National Cancer Institute (P30CA016056)
Article History
Accepted: 12 August 2023
First Online: 26 August 2023
Declarations
:
: This work was funded by Amgen and the National Cancer Institute (NCI) grant P30CA016056 involving the use of Roswell Park Comprehensive Cancer Center’s BMPK Shared Resource.
: P.T. received consulting fees from ADC therapeutics, TG therapeutics, Genmab, Genentech, Lilly USA, and Seagen. F.J.H.I. is an advisory Board Member for Amgen, Karyopharm Therapeutics, Celgene Corporation, Kura Oncology, AbbVie Inc., Seattle Genetics Inc., Epizyme, Pharmacyclics, Gilead, Kite Pharma, Novartis, and MorphoSys. F.J.H.I. also is a member of the Speaker Bureau of MorphoSys. Lan-Hsi Lin, Mohammad Ghasemi, Sarah M. Burke, Cory K. Mavis, Jenna R. Nichols, Donald E. Mager, and Andrew K.L. Goey declare that they have no conflicts of interest that might be relevant to the contents of this manuscript.
: The clinical study was performed per the International Council for Harmonization Good Clinical Practice Guideline and the ethical principles of the Declaration of Helsinki and was approved by the institutional review board of Roswell Park Comprehensive Cancer Center (protocol no. I-240813).
: All patients provided written informed consent prior to enrollment in the study.
: Not applicable.
: The NONMEM control stream for nonlinear-mixed effect PK/PD modeling has been made available in Supplementary File S6.
: DEM, FJHI, and AKLG designed the project and provided supervision; LL and MG developed the PK/PD model and performed the data analysis; SMB performed the LC–MS/MS analysis; CKM performed the proteasome activity analysis; JRN, PT, and FJHI collected clinical data; FJHI acquired funding; DEM, FJHI, and AKLG supported interpretation of the results; LL and A.K.L.G. wrote the original draft; and all authors critically read, revised, and approved the final manuscript.