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CPT Pharmacometrics Syst Pharmacol 2022 03 22;11(3):384-394. Epub 2022 Feb 22.

Pharmacokinetics Dynamics and Metabolism Department, Sanofi R&D, Paris, France.

Tusamitamab ravtansine is an anti-CEACAM5 antibody-drug conjugate indicated in patients with solid tumors. Based on a previous developed semimechanistic model describing simultaneously pharmacokinetic (PK) of SAR408701, two of its active metabolites: DM4 and methyl-DM4 and naked antibody, with integration of drug-to-antibody data, the main objective of the present analysis was to evaluate covariate's impact in patients from phase I/II study (n = 254). Demographic and pathophysiologic baseline covariates were explored to explain interindividual variability on each entity PK parameter. Read More

J Pharmacokinet Pharmacodyn 2022 Jun 15;49(3):381-394. Epub 2022 Feb 15.

Sanofi R&D, Pharmacokinetics Dynamics and Metabolism Department, 1 Avenue Pierre Brossolette, Chilly-Mazarin, 91380, Paris, France.

Tusamitamab ravtansine (SAR408701) is an antibody-drug conjugate (ADC), combining a humanized monoclonal antibody (IgG1) targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and a potent cytotoxic maytansinoid derivative, DM4, inhibiting microtubule assembly. SAR408701 is currently in clinical development for the treatment of advanced solid tumors expressing CEACAM5. It is administered intravenously as a conjugated antibody with an average Drug Antibody Ratio (DAR) of 3. Read More

Ann Oncol 2022 04 10;33(4):416-425. Epub 2022 Jan 10.

Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain; Medical Oncology Department, IOB-Quiron, UVic-UCC, Barcelona, Spain.

Background: Tusamitamab ravtansine (SAR408701) is an antibody-drug conjugate composed of a humanized monoclonal antibody that binds carcinoembryonic antigen-related cell adhesion molecule-5 (CEACAM5) and a cytotoxic maytansinoid that selectively targets CEACAM5-expressing tumor cells. In this phase I dose-escalation study, we evaluated the safety, pharmacokinetics, and preliminary antitumor activity of tusamitamab ravtansine in patients with solid tumors.

Patients And Methods: Eligible patients were aged ≥18 years, had locally advanced/metastatic solid tumors that expressed or were likely to express CEACAM5, and had an Eastern Cooperative Oncology Group Performance Status of 0 or 1. Read More

Clin Cancer Res 2020 12 12;26(24):6589-6599. Epub 2020 Oct 12.

Sanofi R&D, Vitry-sur-Seine, France.

Purpose: Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a glycoprotein that has limited expression in normal adult tissues, but is overexpressed in carcinomas of the gastrointestinal tract, the genitourinary and respiratory systems, and breast cancer. As such, CEACAM5 is an attractive target for antibody-based therapies designed to selectively deliver cytotoxic drugs to certain epithelial tumors. Here, we describe preclinical data for a novel antibody-drug conjugate (ADC), SAR408701, which consists of an anti-CEACAM5 antibody (SAR408377) coupled to a maytansinoid agent DM4 via a cleavable linker. Read More