A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer

Dostarlimab (Jemperli, GlaxoSmithKline) is an anti-programmed death receptor-1 monoclonal antibody (anti-PD-1) recently tested in a non-randomized, phase II trial (NCT04165772) which included patients with mismatch repair-deficient, locally advanced rectal cancer. Among the first 12 patients treated...

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Detalles Bibliográficos
Autores principales: Powell, Kerrington, Olivier, Timothée, Prasad, Vinay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9789610/
https://www.ncbi.nlm.nih.gov/pubmed/36564825
http://dx.doi.org/10.1186/s13063-022-06988-1
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author Powell, Kerrington
Olivier, Timothée
Prasad, Vinay
author_facet Powell, Kerrington
Olivier, Timothée
Prasad, Vinay
author_sort Powell, Kerrington
collection PubMed
description Dostarlimab (Jemperli, GlaxoSmithKline) is an anti-programmed death receptor-1 monoclonal antibody (anti-PD-1) recently tested in a non-randomized, phase II trial (NCT04165772) which included patients with mismatch repair-deficient, locally advanced rectal cancer. Among the first 12 patients treated with dostarlimab, 100% achieved a clinical complete response with no patients experiencing progression or recurrence to date. Most impressive, none required chemotherapy, radiotherapy or surgery the prevailing standard of care. In this paper, we discuss the impressive results of this trial and how they relate to cancer policy, as well as propose a novel trial methodology to assess dostarlimab.
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spelling pubmed-97896102022-12-25 A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer Powell, Kerrington Olivier, Timothée Prasad, Vinay Trials Commentary Dostarlimab (Jemperli, GlaxoSmithKline) is an anti-programmed death receptor-1 monoclonal antibody (anti-PD-1) recently tested in a non-randomized, phase II trial (NCT04165772) which included patients with mismatch repair-deficient, locally advanced rectal cancer. Among the first 12 patients treated with dostarlimab, 100% achieved a clinical complete response with no patients experiencing progression or recurrence to date. Most impressive, none required chemotherapy, radiotherapy or surgery the prevailing standard of care. In this paper, we discuss the impressive results of this trial and how they relate to cancer policy, as well as propose a novel trial methodology to assess dostarlimab. BioMed Central 2022-12-24 /pmc/articles/PMC9789610/ /pubmed/36564825 http://dx.doi.org/10.1186/s13063-022-06988-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Powell, Kerrington
Olivier, Timothée
Prasad, Vinay
A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
title A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
title_full A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
title_fullStr A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
title_full_unstemmed A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
title_short A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
title_sort novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9789610/
https://www.ncbi.nlm.nih.gov/pubmed/36564825
http://dx.doi.org/10.1186/s13063-022-06988-1
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