Introduction: Joint modeling methodology that integrates longitudinal biomarkers and time-to-event outcomes has become an essential component of pharmacometric analyses in…
Read morePoster: Drug/Disease Modelling - Oncology
M-PROTEIN DYNAMIC METRICS TO SUPPORT EARLY DRUG DEVELOPMENT DECISIONS IN MULTIPLE MYELOMA
Objectives Model-derived tumor dynamic metrics have shown promise in predicting overall survival (OS) [1,2,3] to support late-stage drug development (DD)….
Read moreREVIEW OF PHARMACOKINETIC AND PHARMACODYNAMIC MODELLING OF LYMPHODEPLETING AGENTS IN CAR-T CELL THERAPY
Introduction/objectives: Chimeric antigen receptor (CAR) T-cell therapy is an immunotherapy that has transformed the treatment of haematological malignancies by enabling…
Read moreTranslational modelling of pembrolizumab reveals a knowledge gap in immune checkpoint inhibitor dose development
Background Optimal dosing of immune checkpoint inhibitors (ICI) like programmed death-1 (PD-1) inhibitors remains uncertain, as dose–response relationships are not…
Read moreIsatuximab SC versus IV in patients with Relapsed/Refractory Multiple Myeloma: Insights from longitudinal PK/PD Analysis of Serum M-Protein in the non-inferiority IRAKLIA Trial
Introduction: The subcutaneous (SC) formulation of isatuximab (Isa) combined with pomalidomide and dexamethasone (Pd) demonstrated non-inferiority to Isa intravenous (IV)…
Read moreImpact of soluble BCMA on the PKPD assessment and dose selection for BCMA 4-1BBL
Introduction: BCMA 4-1BBL is a costimulatory molecule designed to enhance T-cell engager efficacy in multiple myeloma (MM). Its bispecific binding…
Read moreA Model-Informed Quantitative Framework for First-in-Human Dose Selection of T-Cell Receptor Mimetics in Acute Myeloid Leukemia
Objectives: T-cell receptor mimetic (TCRm) T-cell engagers (TCEs) that recognize peptide-Human Leukocyte Antigen (pHLA) complexes represent an emerging class of…
Read moreA population modelling framework to support early clinical development of BI-1206, a monoclonal antibody blocking FcγRIIB
Objectives BI-1206 is a fully human monoclonal antibody that targets the only inhibitory Fcγ receptor (FcγRIIB), a regulator of antibody…
Read moreMODEL-INFORMED DOSAGE SELECTION FOR GOCATAMIG, A TRI-SPECIFIC, HALF-LIFE–EXTENDED DLL3-DIRECTED T-CELL ENGAGER IN PATIENTS WITH SMALL CELL LUNG CANCER AND OTHER NEUROENDOCRINE CANCERS
Objectives: Gocatamig (MK-6070), is a DLL3-targeting T-cell engager that redirects T cells to kill DLL3-expressing cancer cells. Gocatamig has shown…
Read moreExposure–response evaluation and simulation studies of IMC-001 using a model incorporating FcRn recycling
Objectives IMC-001 is a novel PD-L1 antibody that is a fully human anti-PD-L1 IgG1 monoclonal antibody which has shown promising…
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