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Ide T, Osawa M, Sanghavi K, et al. Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. Cancer Chemother Pharmacol. 2021;doi: 10.1007/s00280-021-04365-4.
Ide, T., Osawa, M., Sanghavi, K., & Vezina, H. E. (2021). Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. Cancer chemotherapy and pharmacology, . https://doi.org/10.1007/s00280-021-04365-4
Ide, Takafumi, et al. "Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma." Cancer chemotherapy and pharmacology vol. (2021). doi: https://doi.org/10.1007/s00280-021-04365-4
Ide T, Osawa M, Sanghavi K, Vezina HE. Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. Cancer Chemother Pharmacol. 2021 Nov 26; doi: 10.1007/s00280-021-04365-4. Epub 2021 Nov 26. PMID: 34825942.
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Cancer Chemother Pharmacol. 2021 Nov 26; doi: 10.1007/s00280-021-04365-4. Epub 2021 Nov 26.

Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma.

Cancer chemotherapy and pharmacology

Takafumi Ide, Mayu Osawa, Kinjal Sanghavi, Heather E Vezina

Affiliations

  1. Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08648, USA.
  2. Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08648, USA. [email protected].

PMID: 34825942 DOI: 10.1007/s00280-021-04365-4

Abstract

PURPOSE: Elotuzumab plus pomalidomide/dexamethasone (E-Pd) demonstrated efficacy and safety in relapsed and refractory multiple myeloma (RRMM). The clinical pharmacology of elotuzumab [± lenalidomide/dexamethasone (Ld)] was characterized previously. These analyses describe elotuzumab population pharmacokinetics (PPK), the effect of Pd, and assess elotuzumab exposure-response relationships for efficacy and safety in patients with RRMM.

METHODS: A previously established PPK model was updated with E-Pd data from the phase 2 ELOQUENT-3 study (NCT02654132). The dataset included 8180 serum concentrations from 440 patients with RRMM from 5 clinical trials. Elotuzumab PK parameter estimates were used to generate individual daily time-varying average concentrations (daily C

RESULTS: Elotuzumab PK were well-described by a two-compartment model with parallel linear and Michaelis-Menten elimination from the central compartment (V

CONCLUSIONS: The PPK model adequately described the data and was appropriate for determining exposures for exposure-response analyses. There were no clinically relevant differences in elotuzumab exposures between Pd and Ld backbones. In ELOQUENT-3, increasing elotuzumab daily C

© 2021. The Author(s).

Keywords: Elotuzumab; Multiple myeloma; Pharmacokinetics; Progression-free survival; Safety

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