DARZALEX (daratumumab)-based regimens significantly improved clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma
June 3, 2024 – Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical – Janssen, Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, multiple myeloma
- 88% of transplant-eligible patients achieved a complete response or better, and 47% of patients sustained MRD-negativity for longer than one year with daratumumab subcutaneous formulation-based regimens in the phase 3 PERSEUS study
- 7.5 years median overall survival achieved with daratumumab-based regimen in phase 3 MAIA final survival analysis is the longest reported in patients ineligible for transplant.
3 June 2024 — Beerse, Belgium — Janssen-Cilag International, a Johnson & Johnson company today announced data from the phase 3 PERSEUS study showing deepening of responses and sustained minimal residual disease (MRD) negativity at both 10-5 and 10-6 levels with a DARZALEX (daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone (D-VRd), followed by a maintenance regimen of daratumumab SC plus lenalidomide (D-R), for the treatment of patients with transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM). The rates of deep and sustained MRD negativity were associated with improved progression-free survival (PFS) with daratumumab SC-based quadruplet regimen in these patients versus VRd. The data was featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from 31 May-4 June (Abstract #7502) and will be presented at the 2024 European Hematology Association (EHA) Congress, taking place in Madrid from 13-16 June (Abstract #S201).
“Our ambition is to eliminate cancer by delivering innovative options such as daratumumab, that yield deep and durable responses from first-line treatment to have the greatest impact,” said Edmond Chan MBChB MD (Res), EMEA Therapeutic Area lead Haematology, Johnson & Johnson Innovative Medicine. “We never settle and remain focused on advancing daratumumab-based regimens to transform the experiences of multiple myeloma patients today and tomorrow.”
In the PERSEUS study, the D-VRd arm (n=355) showed deeper responses and higher rates of MRD negativity over time, at both 10-5 and 10-6 levels, compared to the VRd arm (n=354), with higher rates of complete response or better at the end of consolidation (44.5% vs 34.7%) and maintenance (87.9% vs 70.1%). Rates of MRD negativity at 10-6 increased over time and were consistently higher in the D-VRd vs VRd arm: 43.9% vs 20.9% (p=0.0001) at 12 months; 57.7% vs 27.4% (p=0.0001) at 24 months, and 63.9% vs 30.8% (p=0.0001) at 36 months.
The D-VRd arm also demonstrated higher rates of sustained MRD negativity at 10-6 for at least 12 months, compared to the VRd arm: 47.3% vs 18.6% (p<0.0001). The PFS rate at 48 months was 84.3% for the D-VRd arm, compared to 67.7% for the VRd arm (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.30-0.59; p<0.0001).
The overall safety profile of D-VRd was previously presented at the 2023 American Society of Hematology (ASH) annual meeting in December and was consistent with the known safety profiles for daratumumab SC and VRd. The most common (>10%) grade 3/4 haematologic and non-haematologic adverse events (AEs) with D-VRd vs VRd were neutropenia (62.1% vs 51.0%), thrombocytopenia (29.1% vs 17.3%), diarrhoea (10.5% vs 7.8%), pneumonia (10.5% vs 6.1%) and febrile neutropenia (9.4% vs 10.1%).
“MRD-negativity is an important measure in predicting long-term progression-free survival for patients with multiple myeloma,” said Dr Paula Rodriguez-Otero, department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain. “The higher rates of deep and sustained MRD negativity with this daratumumab subcutaneous formulation-based regimen underscore the potential of D-VRd and D-R maintenance, to shift the treatment paradigm for transplant-eligible patients with newly diagnosed multiple myeloma, and bring us closer to the potential for a functional cure.”
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