DARZALEX® (daratumumab) Subcutaneous Formulation-Based Quadruplet Therapy Regimen Shows Significant Improvement in Outcomes for Patients with Transplant-Eligible Newly Diagnosed Multiple Myeloma

DARZALEX® (daratumumab) Subcutaneous Formulation-Based Quadruplet Therapy Regimen Shows Significant Improvement in Outcomes for Patients with Transplant-Eligible Newly Diagnosed Multiple Myeloma

Daratumumab subcutaneous-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimen¹

First presentation of data from Phase 3 PERSEUS study highlighted in late-breaking abstract session at 2023 ASH Annual Meeting and simultaneously published in The New England Journal of Medicine^1,2

BEERSE, BELGIUM, Dec. 12, 2023 (GLOBE NEWSWIRE) -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the first data from the Phase 3 PERSEUS study highlighting significant clinical improvement with a DARZALEX^® (daratumumab) subcutaneous (SC) formulation-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM).¹ The data, showing significantly improved progression-free survival (PFS) in the Phase 3 study evaluating TE NDMM and clinically significant improvement in rates of overall complete response (CR) or better and minimal residual disease (MRD) negativity over the comparator arm,¹ were featured as a late-breaking oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #LBA-1), taking place in San Diego, California from 9-12 December. The data were published simultaneously in The New England Journal of Medicine.²

The PERSEUS study, conducted in collaboration with the European Myeloma Network, found that induction and consolidation treatment with daratumumab SC in combination with bortezomib, lenalidomide and dexamethasone (D-VRd), followed by daratumumab SC and lenalidomide (D-R) maintenance, reduced the risk of disease progression or death by 58 percent (Hazard Ratio [HR], 0.42; 95 percent Confidence Interval [CI] 0.30-0.59; P <0.0001), compared to bortezomib, lenalidomide and dexamethasone (VRd) alone followed by lenalidomide (R) maintenance.¹ The quadruplet regimen also significantly increased the depth of response compared to treatment with VRd alone, with higher rates of CR or better, stringent CR (sCR), and MRD negativity.¹

“The progression-free survival that was achieved in transplant-eligible patients who were treated with the daratumumab subcutaneous-based induction, consolidation and maintenance therapy regimen is unprecedented in a Phase 3 clinical study evaluating this patient population, but it is not unexpected as these findings build on a number of studies that previously demonstrated clinical benefit with daratumumab-based regimens in this patient population,” said Pieter Sonneveld, M.D., Ph.D., Professor of Hematology at the Erasmus University of Rotterdam and Chair of the Erasmus MC Cancer Institute, Rotterdam, Netherlands.^† “The results we see across clinically relevant subgroups, including in patients who present with advanced disease or who are considered high risk, are promising for clinicians who are on the frontlines of treating patients who are newly diagnosed with this complex disease.”

The estimated 48-month PFS rates were 84.3 percent for D-VRd vs 67.7 percent for VRd.¹ The consistent PFS improvement with D-VRd vs VRd was observed across most clinically relevant subgroups, including patients with International Staging System (ISS) stage III disease (HR, 0.42; 95 percent CI, 0.22-0.83) or high cytogenetic risk (HR, 0.59; 95 percent CI, 0.36-0.99).¹ Treatment with D-VRd also resulted in deeper responses compared with VRd, including higher rates of sCR (69.3 percent vs 44.6 percent; P<0.0001), and ≥CR (87.9 percent vs 70.1 percent; P<0.0001).¹ Overall MRD negativity rates (10^–5) were higher with D-VRd versus VRd (75.2 percent vs 47.5 percent; P<0.0001).¹ Sustained MRD negativity rates (for ≥12 months) more than doubled with D-VRd (64.8 percent vs 29.7 percent; P<0.0001).¹ Overall survival (OS) data are not yet mature but trending favourably for the D-VRd arm compared to VRd.¹

“The impressive results from the PERSEUS study highlight the potential of a daratumumab subcutaneous-based, quadruplet therapy combination to improve outcomes for patients with newly diagnosed multiple myeloma,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “We are encouraged by these results, and the opportunity to provide one more treatment option for patients. The results of PERSEUS reinforce our commitment to developing transformative treatment regimens, as we work towards our wider goal of curing multiple myeloma." 

The overall safety profile of D-VRd was consistent with the known safety profiles for daratumumab SC and VRd. The most common (>10 percent) grade 3/4 haematologic and non-haematologic adverse events (AEs) with D-VRd vs VRd were neutropenia (62.1 percent vs 51.0 percent), thrombocytopenia (29.1 percent vs 17.3 percent), diarrhoea (10.5 percent vs 7.8 percent), pneumonia (10.5 percent vs 6.1 percent), and febrile neutropenia (9.4 percent vs 10.1 percent).¹

“We now have evidence supporting this daratumumab subcutaneous-based quadruplet induction and consolidation regimen and doublet maintenance regimen as a potential standard of care in transplant-eligible disease, complementing data from the Phase 3 MAIA study, which established a daratumumab-based triplet therapy as standard of care in transplant-ineligible disease,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Johnson & Johnson Innovative Medicine. “We will continue to advance innovative regimens and approaches with daratumumab to deliver on our commitment of transforming outcomes for patients with multiple myeloma.”