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      1. EMEA/
      2. Newsroom/
      3. New long-term progression free survival data projections reinforce subcutaneous DARZALEX® (daratumumab) quadruplet therapy as a foundational standard of care for patients with newly diagnosed multiple myeloma
      Newsroom

      New long-term progression free survival data projections reinforce subcutaneous DARZALEX® (daratumumab) quadruplet therapy as a foundational standard of care for patients with newly diagnosed multiple myeloma

      Median progression free survival projected to be 17 years for transplant eligible patients receiving daratumumab-based regimen1

      April 23, 2025
      9 min read

      Beerse, Belgium (23 April 2025) - Janssen-Cilag International NV, a Johnson & Johnson company, announced new data from an analysis modelling long-term progression free survival (PFS) in transplant eligible (TE) and transplant ineligible (TIE) newly diagnosed multiple myeloma (NDMM) patients treated with DARZALEX® (daratumumab)-subcutaneous (SC) therapy in combination with bortezomib, lenalidomide and dexamethasone (VRd).1 These data, which were presented at the 6th European Myeloma Network (EMN) meeting in Athens, Greece, reported that median PFS (mPFS) projections based on the PERSEUS and CEPHEUS trials were significantly longer with daratumumab-VRd regimens compared to VRd regimens.1

      “Survival outcomes for people newly diagnosed with multiple myeloma may now extend beyond the duration that can be captured in a clinical trial, and modelling approaches are becoming even more common to help estimate these improvements,” said Pieter Sonneveld M.D., Ph.D, Head of the Department of Hematology, Erasmus University Medical Center. “The PFS projections presented indicate that people with newly diagnosed multiple myeloma who are eligible for transplant and treated with the PERSEUS regimen may live more than 17 years without their disease progressing. These data reinforce the critical role of transplant with daratumumab maintenance therapy to achieving the best possible outcomes for patients.”

      The PERSEUS trial enrolled patients with TE NDMM who had a median age of 60 years and the CEPHEUS trial enrolled patients with TIE or TE NDMM who had a median age of 70 years.2,3 In PERSEUS, after a median follow-up of 47.5 months, daratumumab-VRd + daratumumab SC and lenalidomide (DR) maintenance led to a reduction in risk of progression or death by 58 percent versus VRd + lenalidomide (R).2 In CEPHEUS, after a median follow-up of 58.7 months, daratumumab-VRd resulted in a 43 percent reduction versus VRd.3 Based on these results, mPFS has not yet been reached in the daratumumab-VRd arm for either trial,2,3 supporting the use of long-term modelling to inform economic and clinical decision making. Modelling showed that in PERSEUS, the best-fit mPFS estimates were 17.1 years (13.2-21.2 years) for daratumumab-VRd + DR maintenance versus 7.3 years (6.3-9.9 years) for VRd + R maintenance.1,4 For the CEPHEUS TIE population, mPFS estimates were 8.3 years (8.0-9.8 years) for daratumumab-VRd versus 4.4 years (4.3-4.5 years) for VRd.1,4 Both models showed that the addition of daratumumab significantly extended mPFS.

      “Improving long-term outcomes remains the key goal in treatment of multiple myeloma. At diagnosis, the median age of people with newly diagnosed multiple myeloma is about 65 years old,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “These PFS projections suggest that some patients receiving daratumumab-VRd could potentially remain progression free and offers them hope of living an average life expectancy. These data continue to build on the body of evidence for daratumumab SC, cementing it as a transformative, frontline therapy, regardless of transplant eligibility.”

      Editor’s Notes

      About study methodology
      The objective of this analysis was to extrapolate progression free survival (PFS) data from transplant eligible (TE) patients in PERSEUS and transplant ineligible (TIE) patients in CEPHEUS (TIE subgroup) to estimate long-term PFS outcomes of daratumumab, bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) in the frontline setting.1

      The UK National Institute for Health and Clinical Excellence (NICE) health technology assessment guidance on extrapolating survival data is a recognised, rigorous methodology for long-term extrapolation. Seven parametric distributions were applied to model PFS data; exponential, Weibull, gamma, Gompertz, log-logistic, log-normal, and generalized gamma. Individual parametric curves were fit for the daratumumab-VRd and VRd groups.1 The NICE guidance ensured that extrapolations were performed using rigorous and standardised methodologies.5

      Long-term extrapolations were capped by UK general population data for 2020–2022 on disease-specific and all-cause mortality, utilising the median age of the population and the proportion of male patients in the cohort at the initiation of treatment (per NICE guidance). PFS projections begin at the median age of the population.1

      About daratumumab and daratumumab SC
      Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

      In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.6 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. Daratumumab subcutaneous is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.7

      CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.8 Daratumumab may also have an effect on normal cells.8 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression free survival and/or overall survival.2,9,10,11,12,13,14,15,16,17

      For further information on daratumumab, please see the Summary of Product Characteristics at: https://ec.europa.eu/health/documents/community-register/html/h1101.htm.

      About the PERSEUS and CEPHEUS studies
      The PERSEUS study (NCT03710603) is being conducted in collaboration with the European Myeloma Network as the sponsor.18 PERSEUS is an ongoing, randomised, open-label, Phase 3 study comparing the efficacy and safety of daratumumab, bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) and autologous stem cell transplant (ASCT) followed by D-R maintenance versus standard bortezomib, lenalidomide, and dexamethasone (VRd) and ASCT followed by R maintenance in patients with transplant eligible newly diagnosed multiple myeloma (NDMM) (n=355).17 The primary endpoint is progression free survival (PFS), and secondary endpoints include overall complete response or better rate, and overall Minimal Residual Disease (MRD).17 Daratumumab subcutaneous (SC) was discontinued after at least 24 months of D-R maintenance therapy in patients who had a complete response or better and had sustained MRD-negative status for at least 12 months.17 The median age is 61.0 (range, 32-70) years for patients in the daratumumab-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm.17 The study is being conducted in 13 countries in Europe and Australia.18 On 23 October 2024, an indication extension for daratumumab-VRd was approved by the European Commission for newly diagnosed patients with multiple myeloma who are eligible for ASCT, based on the results of the PERSEUS study.3,19

      CEPHEUS (NCT03652064) is an ongoing, randomised, open-label, Phase 3 study comparing SC daratumumab-VRd with standard VRd.2,20 The trial has enrolled 395 patients with NDMM who are either ineligible for stem cell transplantation (SCT) or for whom SCT is not planned.2 The primary endpoint is overall MRD-negativity rate.2 The minimum age for participation is 18 years for patients in both the daratumumab-VRd arm and VRd arm, with a median patient age of 70 (range 31-80).2 The study is being conducted in 13 countries across North America, South America, and Europe.20 On 7 April 2025, an indication extension for daratumumab-VRd was approved by the European Commission for newly diagnosed patients with multiple myeloma, based on the results of the CEPHEUS study.2,21

      About Johnson & Johnson
      At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

      Learn more at www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea. Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies.

      Cautions Concerning Forward-Looking Statements
      This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

      *Dr. Pieter Sonneveld has provided consulting, advisory, and speaking services to Janssen; he has not been paid for any media work.

      Media contact
      Jenni Mildon
      [email protected]
      +44 7920 418 552

      Investor contact
      Lauren Johnson
      [email protected]

      CP-514463
      April 2025

      1 Sonneveld P, et al. Modelling long-term progression-free survival in transplant eligible and transplant-ineligible newly diagnosed multiple myeloma treated with daratumumab, bortezomib, lenalidomide, and dexamethasone. Oral Presentation. 6th European Myeloma Network (EMN) meeting. April 10-12, 2025.
      2 Usmani S Z, et al. Daratumumab + bortezomib/lenalidomide/dexamethasone in patients with transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: results of the phase 3 CEPHEUS study. Oral presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024.
      3 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. June 3, 2024.
      4 Sonneveld P, et al. Modelling long-term progression-free survival in transplant-eligible and transplant-ineligible newly diagnosed multiple myeloma treated with daratumumab, bortezomib, lenalidomide, and dexamethasone. Abstract. 6th European Myeloma Network (EMN) meeting. April 10-12, 2025.
      5 Latimer N. NICE DSU Technical Support Document 14: undertaking survival analysis for economic evaluations alongside clinical trials - extrapolation with patient-level data. 2011. Available at: http://www.nicedsu.org.uk. Last accessed: April 2025.
      6 Johnson & Johnson [data on file]. RF-452129. Number of patients treated with DARZALEX worldwide as of December 2024.
      7 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: http://www.businesswire.com/news/home/20200604005487/en/European-Commission-GrantsMarketingAuthorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-SubcutaneousFormulation-for-all-CurrentlyApproved-Daratumumab-Intravenous-Formulation-Indications. Last accessed: April 2025.
      8 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025.
      9 Moreau P, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open label, phase 3 study. Lancet 2019;394(10192):29-38.
      10 Facon T, et al. MAIA Trial Investigators. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med 2019;380(22):2104-2115.
      11 Mateos MV, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. The Lancet 2020;395:132-141.
      12 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22(6):801-812.
      13 Palladini G, et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020;2;136(1):71-80.
      14 Chari A et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981.
      15 Bahlis NJ, et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia 2020;34(7):1875-1884.
      16 Mateos MV, et al. Daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone in patients with previously treated multiple myeloma: three-year follow-up of CASTOR. Clin Lymphoma Myeloma Leuk 2020;20(8):509-518.
      17 Sonneveld P, et al. Daratumumab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2024; 390:301-313.
      18 Clinicaltrial.gov. Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects with Previously Untreated Multiple Myeloma (Perseus). NCT03710603. Available at: https://www.clinicaltrials.gov/study/NCT03710603. Last accessed: April 2025.. Last accessed: April 2025.
      19 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-sc-based-quadruplet-regimen-approved-by-the-european-commission-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible. Last accessed: April 2025.. Last accessed: April 2025.
      20 Clinicaltrials.gov. A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy. NCT03652064. Available at: https://clinicaltrials.gov/study/NCT03652064?term=NCT03652064&cond=Multiple%20Myeloma&rank=1&a=63. Last accessed: April 2025.. Last accessed: April 2025.
      21 European Commission approves Johnson & Johnson’s subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility. Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-johnson-johnsons-subcutaneous-darzalex-daratumumab-based-quadruplet-regimen-for-the-treatment-of-patients-with-newly-diagnosed-multiple-myeloma-regardless-of-transplant-eligibility. Last accessed: April 2025.