https://orcid.org/0000-0002-9822-4170
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Abstract
Aim: We pooled data from three observational studies (INSIGHT MM, UVEA-IXA and REMIX) to investigate the real-world effectiveness of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory myeloma. Materials & methods: INSIGHT MM was a prospective study conducted in countries across Europe, Asia and North/Latin America while UVEA-IXA and REMIX were multicenter, retrospective/prospective studies conducted in Europe. Patients who had received IRd as ≥2nd line of therapy were analyzed. Primary outcomes were time-to-next treatment (TTNT) and progression-free survival (PFS). Results: Overall, 564 patients were included (median follow-up: 18.5 months). Median TTNT and PFS were 18.4 and 19.9 months; both outcomes were numerically longer for earlier versus later lines. Median treatment duration was 14.0 months. Overall response rate was 64.6%. No new safety concerns were noted. Conclusion: The effectiveness of IRd in routine practice appears similar to the efficacy observed in TOURMALINE-MM1. IRd benefit in earlier versus later lines was consistent with previous reports.
Supplementary data
To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/fon-2023-0604
Author contributions
X Leleu, HC Lee, D Cherepanov, DM Stull, E Terpos: conception or design of the work; X Leleu, HC Lee, JA Zonder, M Macro, K Ramasamy, C Hulin, J Silar, M Kuhn, K Ren, N Bent-Ennakhil, D Cherepanov, DM Stull, E Terpos: acquisition, analysis or interpretation of data of the work; X Leleu, HC Lee, JA Zonder, M Macro, K Ramasamy, C Hulin, J Silar, M Kuhn, K Ren, N Bent-Ennakhil, D Cherepanov, DM Stull, E Terpos: drafting the work or revising it critically for important intellectual content; all authors provided final approval of the manuscript to be published and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
X Leleu, HC Lee and JA Zonder were steering committee members for the INSIGHT MM study. K Ramasamy, N Bent-Ennakhil and E Terpos were steering committee members for the UVEA-IXA study. X Leleu, M Macro and C Hulin were steering committee members for the REMIX study. J Silar, M Kuhn, K Ramasamy, N Bent-Ennakhil, D Cherepanov, DM Stull and E Terpos were steering committee members for INSURE.
Acknowledgments
The authors would like to thank all patients and their families, as well as all investigators for their valuable contributions to this study.
Financial disclosure
These studies were funded by Takeda Development Center Americas, Inc. (TDCA), Lexington, MA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
X Leleu: Honoraria: AbbVie, Amgen, BMS, Janssen-Cilag, Novartis, Roche, Sanofi, Takeda, Pfizer; Non-financial support: Takeda. HC Lee: Consultancy: BMS, Celgene, Genentech, Karyopharm, Legend Biotech, GSK, Sanofi, Oncopeptides, Pfizer, Takeda, Allogene Therapeutics, Janssen Pharmaceutical; Research funding: BMS, Janssen, GSK, Takeda, Regeneron, Amgen. JA Zonder: Consultancy: Prothena, BMS, Takeda, Janssen, Regeneron, Research funding: BMS, Janssen; Member of board of directors/advisory committees: Takeda, BMS. MM: Honoraria: Takeda, Janssen, GSK, Sanofi, BMS/Celgene; Travel, accommodation, and research funding: Takeda, Janssen. K Ramasamy: Honoraria and member of board of directors/advisory committees: Amgen, Janssen, Takeda, BMS/Celgene, GSK, Oncopeptides, Adaptive Biotech, Karyopharm, Pfizer, Sanofi; Research funding: Amgen, Janssen, Takeda, BMS/Celgene, GSK; Travel and conference registration: Amgen, Janssen, Takeda, BMS/Celgene. C Hulin: Honoraria: Janssen, BMS/Celgene, Sanofi, Takeda, AbbVie. J Silar, M Kuhn: None. KRen, NB-E, DC, DMS: Employee: Takeda (D Cherepanov and DM Stull also currently hold equity in Takeda). E Terpos: Research funding, honoraria, and consultancy: Amgen, BMS, GSK, Janssen-Cilag, Takeda, Sanofi; Honoraria only: Eusa Pharma, Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Editorial support was provided by Victoria Enwemadu of Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA. Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Jenny Wilkinson, PhD, and Laura Webb, PhD, of Ashfield MedComms, an Inizio company, funded by Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA, and complied with the Good Publication Practice (GPP) guidelines (DeTora LM, et al. Ann Intern Med 2022;175:1298-304).
Ethical conduct of research
Each of the three studies was conducted in accordance with the Declaration of Helsinki, and any applicable local regulations. The research was approved by local independent review boards or independent ethics committees at each site and informed consent was obtained from all patients.
Data availability statement
The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants’ data supporting the results reported in this article will be made available within 3 months from initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
Open access
This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/