Population Pharmacokinetics and Exposure-Response Analyses for Telisotuzumab Vedotin in Patients With c-Met Protein Overexpressing Tumors.

ABSTRACT: Telisotuzumab vedotin (Teliso-V) is a c-Met-directed antibody-drug conjugate that delivers a cytotoxic microtubule inhibitor monomethyl auristatin E (MMAE) payload to c-Met-expressing tumor cells. It received accelerated approval from the US FDA for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (≥ 50% of tumor cells with strong [3+] staining) at a dose of 1.9 mg/kg every 2 weeks (Q2W; maximum 190 mg for patients ≥ 100 kg) as an intravenous infusion. Population pharmacokinetic (PK) modeling used pooled data from a phase 1 (N = 35) and phase 2 study (N = 269) to describe the Teliso-V conjugate and unconjugated MMAE PK and evaluate the impact of intrinsic and extrinsic factors on exposures in

SUBMITTER: Babel H 

PROVIDER: S-EPMC12945708 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature