Darzalex Faspro (daratumumab and hyaluronidase-fihj) / J&J, Genmab, Halozyme - LARVOL DELTA

Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT03710603 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Minimal residual disease • P3 data • Residual disease • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Daratumumab + Bortezomib/Cyclophosphamide/ Dexamethasone In Newly Diagnosed AL Amyloidosis: OS and Final MOD-PFS: ANDROMEDA Study (BSH 2025) - No abstract available

Amyloidosis

New data reinforce daratumumab as standard of care for multiple myeloma (PharmaTimes) - P3 | N=709 | Perseus (NCT03710603) | N=395 | CEPHEUS (NCT03652064) | Sponsor: Janssen Research & Development, LLC | "New data from Janssen-Cilag International NV suggest that subcutaneous DARZALEX (daratumumab) quadruplet therapy could offer a longer progression free survival for patients with newly diagnosed multiple myeloma. Findings were presented at the 6th European Myeloma Network meeting in Athens...Analysis based on the PERSEUS and CEPHEUS trials showed significant improvements in survival projections. Patients eligible for transplant treated with daratumumab-VRd had a median progression free survival estimate of 17.1 years, compared to 7.3 years for those receiving VRd without daratumumab...In PERSEUS, daratumumab-VRd with maintenance therapy reduced the risk of progression or death by 58 percent. In CEPHEUS, daratumumab-VRd reduced this risk by 43 percent."

P3 data • Multiple Myeloma

Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov) - P2 | N=14 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Apr 2025 ➔ Jul 2026

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Smoldering Multiple Myeloma

Phase 3 AURIGA Study of Subcutaneous Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Therapy in Newly Diagnosed Multiple Myeloma (NDMM) After Autologous Stem Cell Transplant (ASCT) (ONS 2025) - P3 | "200 patients were randomized to daratumumab/lenalidomide (n=99) or lenalidomide (n=101); median ages were 63 and 62 years; 25.3% and 23.5% had ISS stage III disease; 34.4% and 33.7% had high-risk cytogenetics (del[17p], t[4; 14], t[14; 16], t[14; 20], and/or gain/amp[1q21]). At a median follow-up of 32.3 months, MRD-negative (10-5) conversion by 12 months from maintenance start (primary endpoint) favored daratumumab/lenalidomide (50.5%) versus lenalidomide (18.8%; OR, 4.51 [95%CI, 2.37-8.57]; P<0.0001), including in high-risk (43.8% vs 13.3%) and standard-risk (53.8% vs 22.6%) cytogenetic subgroups. MRD-negative (10-5) with complete response or better (≥CR) conversion rate by 12 months was 44.4% for daratumumab/lenalidomide versus 14.9% for lenalidomide."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 3 AQUILA Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma (SMM) (ONS 2025) - P3 | "Interventions: Adults with high-risk SMM for ≤5 years were randomized 1:1 to active monitoring or subcutaneous daratumumab monotherapy in 28-day cycles until 39 cycles, 36 months, or disease progression, whichever came first... 390 patients were randomized to daratumumab (n=194) or active monitoring (n=196). Baseline characteristics were generally balanced between groups. Median daratumumab treatment duration was 38 cycles (35.0 months)."

Clinical • Monotherapy • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

Phase 3 CEPHEUS Study of Bortezomib, Lenalidomide, and Dexamethasone With or Without Daratumumab in Transplant-ineligible or Transplant-deferred Patients With Newly Diagnosed Multiple Myeloma (NDMM) (ONS 2025) - P3 | "Purpose: The phase 3 CEPHEUS study (NCT03652064) evaluated the addition of subcutaneous daratumumab to bortezomib/lenalidomide/dexamethasone (VRd) versus VRd alone in patients with NDMM who are transplant ineligible or for whom transplant was not planned as initial therapy (transplant deferred). 395 patients were randomized to D-VRd (n=197) or VRd (n=198). Median age was 70 years; 28.1% had ISS stage III disease; 13.2% had high-risk cytogenetics (del[17p], t[4; 14], and/or t[14; 16]). At a median follow-up of 58.7 months, MRD-negativity rate was significantly improved with D-VRd versus VRd at the 10-5 threshold (60.9% vs 39.4%; OR, 2.37 [95%CI, 1.58-3.55]; P<0.0001) and 10-6 threshold (46.2% vs 27.3%; OR, 2.24 [95%CI, 1.48-3.40]; P=0.0001), with a benefit across most prespecified subgroups."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

"Ouch, that hurts! Is There a Better Way to Administer this Chemotherapy?". Improving Nurse Satisfaction and Hand Strain with Subcutaneous Administration of Daratumumab-Hyaluronidase (ONS 2025) - "The post-survey revealed a decrease of 63.2% in hand strain and fatigue. Seventy-four percent of nurses experienced a reduction in the need to pause or change hand position during drug administration. Twenty-six percent of nurses still experienced moderate to severe pain."

Oncology

Redefining Frontline Therapy in Patients with Newly Diagnosed Multiple Myeloma (A Focus on the Outcomes of Transplant-Eligible and Transplant-Ineligible Patients as seen in the PERSEUS and MAIA Trials) (ONS 2025) - "Sponsored by Johnson & Johnson. This program includes: -Treatment considerations for frontline Multiple Myeloma treatment -Introduction to DARZALEX and DARZALEX FASPRO -Overview on DARZALEX FASPRO in combination with VRd for Induction and Consolidation in newly diagnosed patients with Multiple Myeloma who are eligible for Autologous Stem Cell Transplant (PERSEUS Trial) -Overview on DARZALEX in Combination with RD alone for newly diagnosed patients with Multiple Myeloma who are ineligible for Autologous Stem Cell Transplant (MAIA Trial) -Important Safety Information -Program Summary"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

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 (GlobeNewswire) - "Janssen-Cilag International NV...today announced that the European Commission (EC) has approved an indication extension of DARZALEX (daratumumab) subcutaneous (SC) formulation in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM)....The Phase 3 CEPHEUS (NCT03652064) study evaluated the efficacy and safety of daratumumab-VRd (n=197) compared to VRd (n=198) for patients with NDMM who are transplant ineligible or for whom ASCT was not planned as initial therapy (transplant ineligible or deferred)."

EMA approval • Multiple Myeloma

Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse (clinicaltrials.gov) - P2 | N=23 | Recruiting | Sponsor: Larysa Sanchez | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2025 ➔ Jun 2025

Enrollment open • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

Daratumumab Desensitization in a Heart Transplant Candidate with Chronic Driveline Infection (ISHLT 2025) - "We describe use of daratumumab desensitization in a BTT heart transplant (HT) candidate with a chronic MDRO driveline infection (DLI) intolerant of conventional desensitization therapies.Case Report The patient was status post LVAD implantation two years prior for NICM, complicated by several gastrointestinal bleeds, a chronic hematoma at the outflow graft impeding LVAD function, and chronic MDRO pseudomonas DLI requiring debridement and chronic suppression with ceftazidime/avibactam...Desensitization was initiated with plasmapheresis (6 sessions), IVIg (2 g/kg) and rituximab (375 mg/m2) with an appropriate decline in her PRAs...Daratumumab-hyaluronidase (dara-hyal) was initiated (starting at 2mg/kg and increasing by 2mg/kg each dose) and IVIg (1g/kg) alternating every other week for four doses each...She was induced with basiliximab and maintained on tacrolimus (goal 12-15 mcg/mL), mycophenolate and methylprednisolone. By 90 days post-HT, she has had no rejection based..."

Cardiovascular • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Infectious Disease • Transplantation

Addition of Daratumumab to Lenalidomide Maintenance Boosts MRD-Negative Conversions in Myeloma Following ASCT (OncLive) - P3 | N=200 | AURIGA (NCT03901963) | Sponsor: Janssen Research & Development, LLC | "The addition of subcutaneous daratumumab (Darzalex) to lenalidomide (Revlimid) maintenance demonstrated improved clinical outcomes compared with lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who underwent autologous stem cell transplant (ASCT) but remained minimal residual disease (MRD) positive post-transplant, according to results from the phase 3 AURIGA study...presented during the 50th Annual Oncology Nursing Congress....Findings showed that the 12-month the MRD-negativity rate (10⁻⁵ threshold) was 50.5% for patients treated with daratumumab plus lenalidomide (n = 99) vs 18.8% for those given lenalidomide alone (n = 101; odds ratio [OR], 4.51; 95% CI, 2.37–8.57; P < .0001)."

P3 data • Multiple Myeloma

EMN22: A Study of Daratumumab Monotherapy in Previously Untreated Patients With Stage 3B Light Chain (AL) Amyloidosis (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Stichting European Myeloma Network | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Amyloidosis • Hematological Disorders

ElLen: Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients (clinicaltrials.gov) - P3 | N=824 | Not yet recruiting | Sponsor: Intergroupe Francophone du Myelome

New P3 trial • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Daratumumab Significantly Reduces Progression Risk in High-Risk Smoldering Multiple Myeloma (OncLive) - P3 | N=390 | AQUILA (NCT03301220) | Sponsor: Janssen Research & Development, LLC | "Treatment with daratumumab (Darzalex) led to a statistically significant reduction in the risk of disease progression or death compared with active monitoring in patients with high-risk smoldering multiple myeloma...At a median follow-up of 65.2 months, daratumumab demonstrated a 51% reduction in the risk of disease progression or death vs active monitoring (HR, 0.49; 95% CI, 0.36–0.67; P < .001). The median progression-free survival (PFS) was not reached (NR) in the daratumumab group (n = 194) vs 41.5 months with active monitoring arm (n = 196); PFS rates at 72 months were 70.9% with daratumumab and 40.8% with active monitoring...Additional findings showed SLiM-based progression to multiple myeloma occurred in 25.8% of patients treated with daratumumab compared with 33.2% in the active monitoring group."

P3 data • Multiple Myeloma

Genmab Announces Net Sales of DARZALEX (daratumumab) for First Quarter of 2025 (GlobeNewswire) - "Genmab A/S...announced today that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,237 million in the first quarter of 2025. Net trade sales were USD 1,829 million in the U.S. and USD 1,409 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab."

Sales • Multiple Myeloma

Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Larysa Sanchez | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ May 2026 | Trial primary completion date: Dec 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Real MM: STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA (clinicaltrials.gov) - P4 | N=450 | Recruiting | Sponsor: University of Turin, Italy | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial primary completion date • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=759 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Aug 2025 ➔ Dec 2025

Monotherapy • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

“Extension of indication to include daratumumab for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma based on results from studies 54767414SMM3001 (AQUILA) and 54767414SMM2001 (CENTAURUS)…as a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated” (European Medicines Agency)

PRAC • Hematological Malignancies • Multiple Myeloma • Oncology

(DARA)/BORTEZOMIB/LENALIDOMIDE/DEXAMETHASONE (D-VRD) WITH D-R MAINTENANCE (MAINT) IN TRANSPLANT-ELIGIBLE (TE) NEWLY DIAGNOSED MYELOMA (NDMM): ANALYSIS OF PERSEUS BASED ON CYTOGENETIC RISK (EBMT 2025) - P3 | "Background: In the primary analysis of the phase 3 PERSEUS study, subcutaneous DARA (DARA SC) + VRd induction/consolidation (ind/consol) and D-R maint improved progression-free survival (PFS) and increased rates of deep and durable responses vs VRd ind/consol and R maint in TE NDMM, regardless of cytogenetic risk. The addition of DARA SC to VRd ind/consol and to R maint provided clinical benefit in terms of PFS and induced higher rates of deep and sustained responses vs VRd ind/consol and R maint across all cytogenetic risk subgroups. This supports D-VRd ind/consol and D-R maint as a new standard of care for TE NDMM, regardless of cytogenetic risk. Clinical Trial Registry: https://www.clinicaltrials.gov/study/NCT03710603"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study. (PubMed, Drug Deliv) - "In a drug delivery scenario including comprehensive administration details and assuming equivalent safety and efficacy, 97.78% preferred the on-body delivery system to a daratumumab/hyaluronidase syringe...They underscored the importance of decreasing nurse physical burden, needlestick injuries, and patient needle phobia. Contrary to the assumption that speed is paramount, nurses prioritized reducing effort, enhancing administration safety, and improving patient comfort over injection speed."

Journal • Pain

Home-Based Daratumumab in Patients With Multiple Myeloma. (PubMed, Eur J Haematol) - P | "This study thus concludes that administration of daratumumab outside the hospital is safe, feasible, and time saving."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

DARA-AIHA: The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia (clinicaltrials.gov) - P1 | N=2 | Completed | Sponsor: Dartmouth-Hitchcock Medical Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Sep 2024

Trial completion • Trial completion date • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immunology