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Pharmacoeconomics

Weight-Based Dosing of Pembrolizumab Every 6 Weeks in the Time of COVID-19

Educational Objective
To understand how oncologists can adjust their recommended dosage of pembrolizumab in a post-COVID-19 world

1 Credit CME

JAMA Oncology

Published Online: May 27, 2020

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Article Information and Disclosures

Daniel A. Goldstein, MD^1,2;

Mark J. Ratain, MD³;

Leonard B. Saltz, MD⁴

Author Affiliations

¹Davidoff Center, Rabin Medical Center, Petach Tikvah, Israel
²Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina, Chapel Hill
³Department of Medicine, University of Chicago, Chicago, Illinois
⁴Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York

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The coronavirus disease 2019 (COVID-19) pandemic has shocked the world and caused a period of both economic and medical catastrophe. Two major challenges face the world of medical oncology. Oncologists need to reconsider all of their clinical practices to decrease the risk of exposure of their patients to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Oncologists also need to consider that the world has changed considerably in economic terms. Now, more than ever, we need to assess whether our recommended therapies will cause financial hardship, on both an individual and a societal level. In this article we propose a solution related to the dosing of pembrolizumab that will maintain therapeutic outcomes, decrease detrimental financial effects of treatment, and decrease exposure risk to SARS-CoV-2.

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Article Information

Corresponding Author: Daniel A. Goldstein, MD, Davidoff Center, Rabin Medical Center, Jabotinsky Street, Petach Tikvah, Israel (danielg3@tauex.tau.ac.il).

Published Online: May 27, 2020. doi:10.1001/jamaoncol.2020.2493

Conflict of Interest Disclosures: Dr Goldstein reported institutional research funding from Merck and personal fees from VIVIO Health. Dr Ratain reported personal fees from Aurobindo Pharma, Apotex, Ascentage Pharma, Teva Pharmaceutical Industries, Cyclacel Pharmaceuticals, Celltrion, Breckenridge Pharmaceutical, Par Pharmaceuticals, Roxane Laboratories, Aptevo Therapeutics, Accord Healthcare, Actavis, Amerigen Pharmaceuticals, Argentum Pharmaceuticals, BPI Labs, Belcher Pharmaceuticals, Dr Reddy’s Laboratories, Fresenius Kabi, Glenmark Pharmaceuticals, Hetero, Mylan, Sandoz, Pneuma Respiratory, and Shionogi; grants from AbbVie, Dicerna Pharmaceuticals, Genentech, and Xencor; and other fees from BeiGene; has a patent to US6395481B1 issued, licensed, and with royalties paid, a patent to EP1629111B1 issued, licensed, and with royalties paid, a patent to US8877723B2 issued, and a patent to US9617583B2 issued; and is director and treasurer of the Value in Cancer Care Consortium. No other disclosures were reported.

References

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Canadian Agency for Drugs and Technologies in Health. CADTH technology review: optimal use 360 report: dosing and timing of immuno-oncology drugs. Published online November 2019. Accessed May 19, 2020. https://www.cadth.ca/sites/default/files/ou-tr/ho0008-dosing-timing-immuno-oncology-drugs.pdf

Goldstein DA , Hirsch A . A policy that encourages wastage of expensive medications—the JW modifier. JAMA Oncol. 2018;4(2):155-156. doi:10.1001/jamaoncol.2017.3997 PubMed Google Scholar Crossref

Lala M , Li M , Sinha V , de Alwis D , Chartash E , Jain L. A six-weekly (Q6W) dosing schedule for pembrolizumab based on an exposure-response (E-R) evaluation using modeling and simulation. J Clin Oncol. 2018;36(15, supp):3062. doi:10.1200/JCO.2018.36.15_suppl.3062 Google Scholar

National Comprehensive Cancer Network. Coronavirus disease 2019 (COVID-19) resources for the cancer care community. Accessed May 19, 2020. https://www.nccn.org/covid-19/

Elassaiss-Schaap J , Rossenu S , Lindauer A , et al. Using model-based “learn and confirm” to reveal the pharmacokinetics-pharmacodynamics relationship of pembrolizumab in the KEYNOTE-001 trial. CPT Pharmacometrics Syst Pharmacol. 2017;6(1):21-28. doi:10.1002/psp4.12132 PubMed Google Scholar Crossref

Merck announces fourth-quarter and full-year 2019 financial results. News release. Merck; February 5, 2020. Accessed May 19, 2020. https://s21.q4cdn.com/488056881/files/doc_financials/2019/q4/Merck-4QFY19-Earnings-News-Release.pdf

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 CME points in the American Board of Surgery’s (ABS) Continuing Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.