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Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis

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Title: Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis
Authors: Stéphane deBotton, Joseph M. Brandwein, Andrew H. Wei, Arnaud Pigneux, Bruno Quesnel, Xavier Thomas, Ollivier Legrand, Christian Recher, Sylvain Chantepie, Mathilde Hunault‐Berger, Nicolas Boissel, Salem A. Nehme, Mark G. Frattini, Alessandra Tosolini, Roland Marion‐Gallois, Jixian J. Wang, Chris Cameron, Muhaimen Siddiqui, Brian Hutton, Gary Milkovich, Eytan M. Stein
Source: Cancer Medicine, Vol 10, Iss 18, Pp 6336-6343 (2021)
Publisher Information: Wiley, 2021.
Publication Year: 2021
Collection: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Subject Terms: acute myeloid leukemia, enasidenib, IDH2 mutations, overall survival, standard of care, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
More Details: Abstract Background The present study evaluated the relative survival benefits associated with enasidenib and current standard of care (SoC) therapies for patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and an isocitrate dehydrogenase 2 (IDH2) mutation who are ineligible for hematopoietic stem cell transplantation (HSCT). Methods Propensity score matching (PSM) analysis compared survival outcomes observed with enasidenib 100 mg daily in the phase I/II AG221‐C‐001 trial and SoC outcomes obtained from a real‐world chart review of patients in France. Results Before matching, enasidenib (n = 195) was associated with numerically improved overall survival (OS) relative to SoC (n = 80; hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.61–1.11). After matching and adjusting for covariates (n = 78 per group), mortality risk was significantly lower with enasidenib than with SoC (HR, 0.67; 95% CI, 0.47–0.97). The median OS was 9.26 months for enasidenib (95% CI, 7.72–13.24) and 4.76 months for SoC (95% CI, 3.81–8.21). Results remained robust across all sensitivity analyses conducted. Conclusions PSM analyses indicate that enasidenib significantly prolongs survival relative to SoC among patients with R/R AML and an IDH2 mutation who are ineligible for HSCT. Future prospective studies are needed to validate these findings using other data sources and to assess the comparative efficacy of enasidenib for other treatment outcomes.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2045-7634
Relation: https://doaj.org/toc/2045-7634
DOI: 10.1002/cam4.4182
Access URL: https://doaj.org/article/a8b6b60e03224a14a77e3d31e872ffc8
Accession Number: edsdoj.8b6b60e03224a14a77e3d31e872ffc8
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  Data: Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis
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  Data: <searchLink fieldCode="AR" term="%22Stéphane+deBotton%22">Stéphane deBotton</searchLink><br /><searchLink fieldCode="AR" term="%22Joseph+M%2E+Brandwein%22">Joseph M. Brandwein</searchLink><br /><searchLink fieldCode="AR" term="%22Andrew+H%2E+Wei%22">Andrew H. Wei</searchLink><br /><searchLink fieldCode="AR" term="%22Arnaud+Pigneux%22">Arnaud Pigneux</searchLink><br /><searchLink fieldCode="AR" term="%22Bruno+Quesnel%22">Bruno Quesnel</searchLink><br /><searchLink fieldCode="AR" term="%22Xavier+Thomas%22">Xavier Thomas</searchLink><br /><searchLink fieldCode="AR" term="%22Ollivier+Legrand%22">Ollivier Legrand</searchLink><br /><searchLink fieldCode="AR" term="%22Christian+Recher%22">Christian Recher</searchLink><br /><searchLink fieldCode="AR" term="%22Sylvain+Chantepie%22">Sylvain Chantepie</searchLink><br /><searchLink fieldCode="AR" term="%22Mathilde+Hunault‐Berger%22">Mathilde Hunault‐Berger</searchLink><br /><searchLink fieldCode="AR" term="%22Nicolas+Boissel%22">Nicolas Boissel</searchLink><br /><searchLink fieldCode="AR" term="%22Salem+A%2E+Nehme%22">Salem A. Nehme</searchLink><br /><searchLink fieldCode="AR" term="%22Mark+G%2E+Frattini%22">Mark G. Frattini</searchLink><br /><searchLink fieldCode="AR" term="%22Alessandra+Tosolini%22">Alessandra Tosolini</searchLink><br /><searchLink fieldCode="AR" term="%22Roland+Marion‐Gallois%22">Roland Marion‐Gallois</searchLink><br /><searchLink fieldCode="AR" term="%22Jixian+J%2E+Wang%22">Jixian J. Wang</searchLink><br /><searchLink fieldCode="AR" term="%22Chris+Cameron%22">Chris Cameron</searchLink><br /><searchLink fieldCode="AR" term="%22Muhaimen+Siddiqui%22">Muhaimen Siddiqui</searchLink><br /><searchLink fieldCode="AR" term="%22Brian+Hutton%22">Brian Hutton</searchLink><br /><searchLink fieldCode="AR" term="%22Gary+Milkovich%22">Gary Milkovich</searchLink><br /><searchLink fieldCode="AR" term="%22Eytan+M%2E+Stein%22">Eytan M. Stein</searchLink>
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  Data: Cancer Medicine, Vol 10, Iss 18, Pp 6336-6343 (2021)
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  Data: <searchLink fieldCode="DE" term="%22acute+myeloid+leukemia%22">acute myeloid leukemia</searchLink><br /><searchLink fieldCode="DE" term="%22enasidenib%22">enasidenib</searchLink><br /><searchLink fieldCode="DE" term="%22IDH2+mutations%22">IDH2 mutations</searchLink><br /><searchLink fieldCode="DE" term="%22overall+survival%22">overall survival</searchLink><br /><searchLink fieldCode="DE" term="%22standard+of+care%22">standard of care</searchLink><br /><searchLink fieldCode="DE" term="%22Neoplasms%2E+Tumors%2E+Oncology%2E+Including+cancer+and+carcinogens%22">Neoplasms. Tumors. Oncology. Including cancer and carcinogens</searchLink><br /><searchLink fieldCode="DE" term="%22RC254-282%22">RC254-282</searchLink>
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  Data: Abstract Background The present study evaluated the relative survival benefits associated with enasidenib and current standard of care (SoC) therapies for patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and an isocitrate dehydrogenase 2 (IDH2) mutation who are ineligible for hematopoietic stem cell transplantation (HSCT). Methods Propensity score matching (PSM) analysis compared survival outcomes observed with enasidenib 100 mg daily in the phase I/II AG221‐C‐001 trial and SoC outcomes obtained from a real‐world chart review of patients in France. Results Before matching, enasidenib (n = 195) was associated with numerically improved overall survival (OS) relative to SoC (n = 80; hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.61–1.11). After matching and adjusting for covariates (n = 78 per group), mortality risk was significantly lower with enasidenib than with SoC (HR, 0.67; 95% CI, 0.47–0.97). The median OS was 9.26 months for enasidenib (95% CI, 7.72–13.24) and 4.76 months for SoC (95% CI, 3.81–8.21). Results remained robust across all sensitivity analyses conducted. Conclusions PSM analyses indicate that enasidenib significantly prolongs survival relative to SoC among patients with R/R AML and an IDH2 mutation who are ineligible for HSCT. Future prospective studies are needed to validate these findings using other data sources and to assess the comparative efficacy of enasidenib for other treatment outcomes.
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