Pembrolizumab weight based dosing – A call for policy change

Amol Patel; Amol Akhade; Purvish Parikh; Atul Sharma; Hemant Malhotra; Kumar Prabhash; Govind Babu; Vanita Noronha; Ullas Batra; Prashant Mehta; Vineet Govinda Gupta; Venkatraman Radhakrishnan; Rakesh Reddy Boya; Bivas Biswas

doi:10.1055/s-0042-1742651

Indian Journal of Medical and Paediatric Oncology, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2022; 43(03): 306-310
DOI: 10.1055/s-0042-1742651

Policy Brief

Pembrolizumab weight based dosing – A call for policy change

Autoren

Amol Patel

¹Department of Medicine, Oncology Centre, INHS, ASVINI, Mumbai
Amol Akhade

²Department of Medical Oncology, Topiwala National Medical College and Nair Hospital, Mumbai, Maharashtra, India
Purvish Parikh

³Department of Medical Oncology, Mumbai Oncocare Centers, Mumbai, Maharashtra, India
Atul Sharma

⁴Department of Medical Oncology, AIIMS, New Delhi, India
Hemant Malhotra

⁵Department of Medical Oncology, Mahatmma Gandhi Medical College Hospital, Jaipur, Rajasthan, India
Kumar Prabhash

⁶Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India
Govind Babu

⁷Department of Medical Oncology, HCG and St John’s Medical College Hospital, Bengaluru, Karnataka, India
Vanita Noronha

⁶Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India
Ullas Batra

⁸Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India
Prashant Mehta

⁹Department of Medical Oncology, Asian Institute of Medical Sciences, Faridabad, Haryana, India
Vineet Govinda Gupta

¹⁰Department of Medical Oncology, Artemis Hospital, Gurugram, Haryana, India
Venkatraman Radhakrishnan

¹¹Department of Medical Oncology, Cancer Institute, Chennai, Tamil Nadu, India
Rakesh Reddy Boya

¹²Department of Medical Oncology, Mahatma Gandhi Cancer Hospital, Vishakhapatnam, Andhra Pradesh, India
Bivas Biswas

¹³Department of Medical Oncology, Tata Medical Center, Kolkata, West Bengal, India

Abstract

Volltext

Referenzen

References
1 Tannock IF, Patel A. Pharmacoeconomics. Ind J Med Paediatr Oncol 2021; 42: 218-220
2 Centanni M, Moes DJAR, Trocóniz IF, Ciccolini J, van Hasselt JGC. Clinical pharmacokinetics and pharmacodynamics of immune checkpoint inhibitors. Clin Pharmacokinet 2019; 58 (07) 835-857
3 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 at: https://www.cadth.ca/sites/default/files/ou-tr/ho0008-dosing-timing-immuno-oncology-drugs.pdf
4 Health Canada. Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies [Internet], 2012. Accessed August 29, 2021 at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.html
5 Patnaik A, Kang SP, Rasco D. et al. Phase I study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in patients with advanced solid tumors. Clin Cancer Res 2015; 21 (19) 4286-4293
6 Chatterjee M, Turner DC, Felip E. et al. Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer. Ann Oncol 2016; 27 (07) 1291-1298
7 Chatterjee MS, Elassaiss-Schaap J, Lindauer A. et al. Population pharmacokinetic/pharmacodynamic modeling of tumor size dynamics in pembrolizumab-treated advanced melanoma. CPT Pharmacometrics Syst Pharmacol 2017; 6 (01) 29-39
8 Garon EB, Rizvi NA, Hui R. et al; KEYNOTE-001 Investigators. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015; 372 (21) 2018-2028
9 Herbst RS, Baas P, Kim D-W. et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016; 387 (10027): 1540-1550
10 Ribas A, Puzanov I, Dummer R. et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol 2015; 16 (08) 908-918
11 Turner DC, Kondic AG, Anderson KM. et al. Pembrolizumab exposure-response assessments challenged by association of cancer cachexia and catabolic clearance. Clin Cancer Res 2018; 24 (23) 5841-5849
12 Reck M, Rodríguez-Abreu D, Robinson AG. et al; KEYNOTE-024 Investigators. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med 2016; 375 (19) 1823-1833
13 Freshwater T, Kondic A, Ahamadi M. et al. Evaluation of dosing strategy for pembrolizumab for oncology indications. J Immunother Cancer 2017; 5: 43
14 Lala M, Li TR, de Alwis DP. et al. A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation. Eur J Cancer 2020; 131: 68-75
15 Keytruda prescribing information (package insert is based on worldwide physician circular S-CCDS-MK3475- IV-112017). 2017
16 National Comprehensive Cancer Network guidelines on cutaneous melanoma. Accessed October 10, 2021 at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf
17 Patail NK, Sher AF, Wu S. Improving tolerability of pembrolizumab with weight based dosing: a meta-analysis. Journal of Clinical Oncology 2021; 39 (15) 2639-2639
18 Mukherjee S, Ibrahimi S, Machiorlatti M. et al. Personalized dosing versus fixed dosing of immune checkpoint inhibitors: a cost analysis study. Am J Ther 2018; 25 (06) e767-e768
19 Low JL, Huang Y, Sooi K. et al. Low-dose pembrolizumab in the treatment of advanced non-small cell lung cancer. Int J Cancer 2021; 149 (01) 169-176
20 Goldstein DA, Gordon N, Davidescu M. et al. A phamacoeconomic analysis of personalized dosing vs fixed dosing of pembrolizumab in firstline PD-L1-positive non-small cell lung cancer. J Natl Cancer Inst 2017;109(11).
21 Goldstein DA, Ratain MJ, Saltz LB. Weight-based dosing of pembrolizumab every 6 weeks in the time of COVID-19. JAMA Oncol 2020; 6 (11) 1694-1695
22 23rd Expert Committee on Selection and Use of Essential Medicines [Internet]. Accessed September 26, 2021 at: https://www.who.int/news-room/events/detail/2021/06/21/default-calendar/23rd-expert-committee-on-selection-and-use-of-essential-medicines
23 Noronha V, Abraham G, Patil V. et al. A real-world data of immune checkpoint inhibitors in solid tumors from India. Cancer Med 2021; 10 (05) 1525-1534
24 Singh N, Aggarwal AN, Gupta D, Behera D. Prevalence of low body mass index among newly diagnosed lung cancer patients in North India and its association with smoking status. Thorac Cancer 2011; 2 (01) 27-31
25 Kaur H, Sehgal IS, Bal A. et al. Evolving epidemiology of lung cancer in India: reducing non-small cell lung cancer-not otherwise specified and quantifying tobacco smoke exposure are the key. Indian J Cancer 2017; 54 (01) 285-290
26 Average height of men and women worldwide [Internet]. Worlddata.info. Accessed November 23, 2021 at: https://www.worlddata.info/average-bodyheight.php
27 Ogungbenro K, Patel A, Duncombe R, Nuttall R, Clark J, Lorigan P. Dose rationalization of pembrolizumab and nivolumab using pharmacokinetic modeling and simulation and cost analysis. Clin Pharmacol Ther 2018; 103 (04) 582-590
28 National dose banding table for pembrolizumab, NHS England. Accessed January 1, 2022 at: https://www.england.nhs.uk/publication/national-dose-banding-table-pembrolizumab-25-mgml/
29 National dose banding table for nivolumab, NHS England. Accessed January 1, 2022 at: https://www.england.nhs.uk/publication/national-dose-banding-table-nivolumab-10mgml/
30 Piccoli M, Selmin F, Mangoni G. et al. 3PC-044 In use physicochemical stability of pembrolizumab under the dilution condition required for use in a day hospital. European Journal of Hospital Pharmacy 2020; 27 (Suppl. 01) A42-A42
31 Sundaramurthi P, Chadwick S, Narasimhan C. Physicochemical stability of pembrolizumab admixture solution in normal saline intravenous infusion bag. J Oncol Pharm Pract 2020; 26 (03) 641-646
32 Le Guyader G, Vieillard V, Mouraud S, Do B, Marabelle A, Paul M. Stability of nivolumab in its original vials after opening and handing in normal saline bag for intravenous infusion. Eur J Cancer 2020; 135: 192-202
33 Geoerger B, Kang HJ, Yalon-Oren M. et al. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol 2020; 21 (01) 121-133
34 Highlights of prescribing information. Accessed January 1, 2022 at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s066lbl.pdf