Academic Journal
Benefit Versus Risk Assessment of Melflufen and Dexamethasone in Relapsed/Refractory Multiple Myeloma:Analyses From Longer Follow-up of the OCEAN and HORIZON Studies
| العنوان: | Benefit Versus Risk Assessment of Melflufen and Dexamethasone in Relapsed/Refractory Multiple Myeloma:Analyses From Longer Follow-up of the OCEAN and HORIZON Studies |
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| المؤلفون: | Sonneveld, Pieter, Richardson, Paul G., Ludwig, Heinz, Dimopoulos, Meletios Athanasios, Schjesvold, Fredrik H., Hájek, Roman, Abdulhaq, Haifaa, Thuresson, Marcus, Norin, Stefan, Bakker, Nicolaas A., Mateos, Maria Victoria |
| المصدر: | Sonneveld , P , Richardson , P G , Ludwig , H , Dimopoulos , M A , Schjesvold , F H , Hájek , R , Abdulhaq , H , Thuresson , M , Norin , S , Bakker , N A & Mateos , M V 2023 , ' Benefit Versus Risk Assessment of Melflufen and Dexamethasone in Relapsed/Refractory Multiple Myeloma : Analyses From Longer Follow-up of the OCEAN and HORIZON Studies ' , Clinical Lymphoma, Myeloma and Leukemia , vol. 23 , no. 9 , pp. 687-696 . https://doi.org/10.1016/j.clml.2023.05.004 |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | /dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being, name=SDG 3 - Good Health and Well-being |
| الوصف: | Introduction: Melphalan flufenamide (melflufen), a first-in-class alkylating peptide-drug conjugate, plus dexamethasone demonstrated superior progression-free survival (PFS) but directionally different overall survival (OS) favoring pomalidomide (hazard ratio [HR], 1.10) in OCEAN. Methods: These analyses further investigated prognostic subgroups impacting survival in updated data from the randomized, phase 3 OCEAN study (NCT03151811; date: February 3, 2022) and the phase 2 HORIZON study (NCT02963493; date: February 2, 2022). Results: In OCEAN, subgroups prognostic for OS were age (P = .011; <65 years favored pomalidomide) and no previous autologous stem cell transplant (ASCT) or progression >36 months after ASCT (P = .001; favored melflufen). Overall, 245 of 495 (49%) patients randomized had received a previous ASCT, of which 202 (82%) had progressed within 36 months following their ASCT. When excluding patients who had progressed <36 months post-ASCT (melflufen group, n = 145; pomalidomide group, n = 148), median OS was 23.6 months with melflufen and 19.8 months with pomalidomide (HR, 0.83 [95% CI, 0.62-1.12]; P = .22). Among patients with triple-class refractory disease in HORIZON, patients who had progressed <36 months post-ASCT (n = 58) had a lower response rate and shorter duration of response and PFS than the remaining patients (n = 52). Safety was consistent with previous reports. Conclusion: These analyses demonstrate a consistent benefit for melflufen and dexamethasone in patients with relapsed/refractory multiple myeloma who have not received an ASCT or progressed >36 months after receiving an ASCT (ClinicalTrials.gov identifier: NCT03151811). |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| DOI: | 10.1016/j.clml.2023.05.004 |
| الاتاحة: | https://pure.eur.nl/en/publications/0b194d82-68ae-4178-ba93-50c2384450ef https://doi.org/10.1016/j.clml.2023.05.004 https://pure.eur.nl/ws/files/98714930/Benefit_Versus_Risk_Assessment_of_Melflufen_and_Dexamethasone_in_RelapsedRefractory_Multiple_Myeloma.pdf http://www.scopus.com/inward/record.url?scp=85164122508&partnerID=8YFLogxK |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.E95716DE |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.clml.2023.05.004 |
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