Modeling Long-Term Progression-Free Survival in Newly Diagnosed Multiple Myeloma Treated With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone

Daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) significantly improved progression-free survival (PFS) versus VRd in newly diagnosed multiple myeloma (NDMM) in transplant eligible (TE; PERSEUS) and transplant-ineligible (TIE; CEPHEUS) populations. Median PFS with DVRd has not been reached in either study. This analysis extrapolated PFS data from PERSEUS and CEPHEUS (TIE subgroup) to estimate long-term outcomes for DVRd. Following UK National Institute for Health and Care Excellence guidance on survival data extrapolation, seven parametric distributions were fitted to model PFS data. In PERSEUS (TE population), the projected median PFS range across distributions was 158-255 months versus 76-119 months and best-fit (exponential distribution) PFS estimates were 205 months (17.1 [range, 13.2-21.2] years, DVRd) versus 87 months (7.3 [range, 6.3-9.9] years, VRd). For CEPHEUS (TIE population), projected median PFS range across distributions was 96-118 months versus 52-54 months and best-fit estimates were 100 months (8.3 [range, 8.0-9.8] years, DVRd) versus 53 months (4.4 [range, 4.3-4.5] years, VRd). PFS projections were significantly longer with DVRd than VRd in TE (additional 118 months; 9.8 years) and TIE patients (additional 47 months; 3.9 years) across all seven distributions. These extrapolations reinforce the benefit of DVRd as standard of care in NDMM regardless of transplant eligibility.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2026-11-09
DOI
https://doi.org/10.1200/jco-26-00384
Primary Topic
Multiple Myeloma Research and Treatments
Type
article
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article

Modeling Long-Term Progression-Free Survival in Newly Diagnosed Multiple Myeloma Treated With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone

Pieter Sonneveld, Saad Z. Usmani, Hermann Einsele, Mario Boccadoro et al.
Journal of Clinical Oncology
Multiple Myeloma Research and Treatments
article

Modeling Long-Term Progression-Free Survival in Newly Diagnosed Multiple Myeloma Treated With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone

Pieter Sonneveld, Saad Z. Usmani, Hermann Einsele, Mario Boccadoro, Thierry T.F. Facon, Meletios Athanasios Dimopoulos, András Borsi, Fredrik Borgsten, Robin L. Carson, Nizar Jacques Bahlis, Anna Sitthi-Amorn, Paula Rodríguez‐Otero, Sonja Zweegman, Philippe Moreau, Vania Tietsche de Moraes Hungria, Melissa Rowe, Marjorie Nobrega, Jianping Wang, Viktor Kovács
article en

Abstract

Daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) significantly improved progression-free survival (PFS) versus VRd in newly diagnosed multiple myeloma (NDMM) in transplant eligible (TE; PERSEUS) and transplant-ineligible (TIE; CEPHEUS) populations. Median PFS with DVRd has not been reached in either study. This analysis extrapolated PFS data from PERSEUS and CEPHEUS (TIE subgroup) to estimate long-term outcomes for DVRd. Following UK National Institute for Health and Care Excellence guidance on survival data extrapolation, seven parametric distributions were fitted to model PFS data. In PERSEUS (TE population), the projected median PFS range across distributions was 158-255 months versus 76-119 months and best-fit (exponential distribution) PFS estimates were 205 months (17.1 [range, 13.2-21.2] years, DVRd) versus 87 months (7.3 [range, 6.3-9.9] years, VRd). For CEPHEUS (TIE population), projected median PFS range across distributions was 96-118 months versus 52-54 months and best-fit estimates were 100 months (8.3 [range, 8.0-9.8] years, DVRd) versus 53 months (4.4 [range, 4.3-4.5] years, VRd). PFS projections were significantly longer with DVRd than VRd in TE (additional 118 months; 9.8 years) and TIE patients (additional 47 months; 3.9 years) across all seven distributions. These extrapolations reinforce the benefit of DVRd as standard of care in NDMM regardless of transplant eligibility.

Journal of Clinical Oncology
Johnson & Johnson (United States) (US), Memorial Sloan Kettering Cancer Center (US), University of Calgary (CA), Korea University (KR), National and Kapodistrian University of Athens (GR), Université de Lille (FR), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Nantes (FR), São Germano Oncologia (BR), Universitätsklinikum Würzburg (DE), Clinica Universidad de Navarra (ES), Johnson & Johnson (United Kingdom) (GB), Erasmus MC Cancer Institute (NL), Vrije Universiteit Amsterdam (NL), Amsterdam UMC Location Vrije Universiteit Amsterdam (NL), Nantes Université (FR)
Multiple Myeloma Research and Treatments
DOISourceOpenAlex
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