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Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma

INTRODUCTION: Patients with follicular lymphoma (FL) receiving third-line or later (3L +) therapy have long survival, which can make estimating long-term overall survival (OS) from trial data challenging. The objective of this study was to estimate long-term OS for mosunetuzumab from the GO29781 tri...

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Autores principales: Sanchez Alvarez, Javier, Jaber, Mahmoud, Blanchet Zumofen, Marie-Hélène
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10673801/
https://www.ncbi.nlm.nih.gov/pubmed/37851321
http://dx.doi.org/10.1007/s40487-023-00245-4
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author Sanchez Alvarez, Javier
Jaber, Mahmoud
Blanchet Zumofen, Marie-Hélène
author_facet Sanchez Alvarez, Javier
Jaber, Mahmoud
Blanchet Zumofen, Marie-Hélène
author_sort Sanchez Alvarez, Javier
collection PubMed
description INTRODUCTION: Patients with follicular lymphoma (FL) receiving third-line or later (3L +) therapy have long survival, which can make estimating long-term overall survival (OS) from trial data challenging. The objective of this study was to estimate long-term OS for mosunetuzumab from the GO29781 trial (NCT02500407) using multiple real-world databases (RWDs) in a Bayesian framework. METHODS: Seven RWD sources for patients with FL receiving 3L + therapy and the expansion cohort in the GO29781 trial for mosunetuzumab were used. Hazard trends from the RWD sources were analyzed, and disease-wide pointwise OS and its corresponding uncertainty were estimated using Bayesian random-effects meta-analysis from the RWD sources. Pointwise OS obtained was used as an informative prior in Bayesian survival extrapolations to data from patients receiving mosunetuzumab. Results after adjusting for background mortality were compared to equivalent frequentist extrapolations using trial data only. RESULTS: Hazard patterns from RWD sources supported a constant or linearly decreasing hazard. Mean pointwise OS for patients with FL receiving 3L + therapy was estimated at 0.52 (95% credible interval, 0.29–0.85) at 8 years. Bayesian extrapolations for mosunetuzumab produced median survival estimates of 11.6 (6.7–20.7) years to 17.0 (6.4–22.7) years depending on the distribution used, reducing uncertainty by 20% to 46% relative to the frequentist estimation. CONCLUSION: Multiple RWD sources can be synthesized to augment the credibility of data with short follow-up, long patient survival, and few events to effectively estimate long-term survival and reduce estimated uncertainty. This method can be applied to other indications with similar characteristics. CLINICAL TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: NCT02500407, July 16, 2015. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40487-023-00245-4.
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spelling pubmed-106738012023-10-18 Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma Sanchez Alvarez, Javier Jaber, Mahmoud Blanchet Zumofen, Marie-Hélène Oncol Ther Original Research INTRODUCTION: Patients with follicular lymphoma (FL) receiving third-line or later (3L +) therapy have long survival, which can make estimating long-term overall survival (OS) from trial data challenging. The objective of this study was to estimate long-term OS for mosunetuzumab from the GO29781 trial (NCT02500407) using multiple real-world databases (RWDs) in a Bayesian framework. METHODS: Seven RWD sources for patients with FL receiving 3L + therapy and the expansion cohort in the GO29781 trial for mosunetuzumab were used. Hazard trends from the RWD sources were analyzed, and disease-wide pointwise OS and its corresponding uncertainty were estimated using Bayesian random-effects meta-analysis from the RWD sources. Pointwise OS obtained was used as an informative prior in Bayesian survival extrapolations to data from patients receiving mosunetuzumab. Results after adjusting for background mortality were compared to equivalent frequentist extrapolations using trial data only. RESULTS: Hazard patterns from RWD sources supported a constant or linearly decreasing hazard. Mean pointwise OS for patients with FL receiving 3L + therapy was estimated at 0.52 (95% credible interval, 0.29–0.85) at 8 years. Bayesian extrapolations for mosunetuzumab produced median survival estimates of 11.6 (6.7–20.7) years to 17.0 (6.4–22.7) years depending on the distribution used, reducing uncertainty by 20% to 46% relative to the frequentist estimation. CONCLUSION: Multiple RWD sources can be synthesized to augment the credibility of data with short follow-up, long patient survival, and few events to effectively estimate long-term survival and reduce estimated uncertainty. This method can be applied to other indications with similar characteristics. CLINICAL TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: NCT02500407, July 16, 2015. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40487-023-00245-4. Springer Healthcare 2023-10-18 /pmc/articles/PMC10673801/ /pubmed/37851321 http://dx.doi.org/10.1007/s40487-023-00245-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial 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-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Sanchez Alvarez, Javier
Jaber, Mahmoud
Blanchet Zumofen, Marie-Hélène
Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma
title Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma
title_full Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma
title_fullStr Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma
title_full_unstemmed Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma
title_short Multiple Real-World Data Sources in a Bayesian Framework to Inform Long-Term Survival Estimates of Mosunetuzumab in Patients with Follicular Lymphoma
title_sort multiple real-world data sources in a bayesian framework to inform long-term survival estimates of mosunetuzumab in patients with follicular lymphoma
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10673801/
https://www.ncbi.nlm.nih.gov/pubmed/37851321
http://dx.doi.org/10.1007/s40487-023-00245-4
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