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

ALACRITY: A phase 1b/2 study of AZD0120 (BCMA/CD19 CAR-T cell therapy) in participants with relapsed or refractory light chain amyloidosis (AL) (ASH 2025) - P1/2 | "Daratumumab+CyBorD (cyclophosphamide, bortezomib, dexamethasone) is approved to treat newly diagnosed AL (ANDROMEDA study), with improved outcomes...This study is registered on ClinicalTrials.gov (NCT07081646). Conclusion This study aims to determine the safety, tolerability, and efficacy of AZD0120 in adult participants with relapsed or refractory AL."

CAR T-Cell Therapy • P1/2 data • Amyloidosis • Hematological Malignancies • Hepatology • Leukemia • Liver Failure • Multiple Myeloma

Daratumumab-based regimens in newly diagnosed mayo 2004 stage 3b AL amyloidosis: A systematic review (ASH 2025) - "Daratumumab-based frontline therapy demonstrates promising hematologic and cardiac responses, with manageable toxicity comparable to that reported in the ANDROMEDA trial. Although survival in most studies is improved compared to bortezomib-based treatment, patients with Mayo 2004 stage 3b disease still have the poorest prognosis among all Mayo stages."

Review • Amyloidosis • Hematological Disorders • Infectious Disease

MagnetisMM-6 part 2: A phase 3, open-label, randomized study of elranatamab in combination with daratumumab and lenalidomide vs daratumumab, lenalidomide, and dexamethasone in transplant-ineligible or -deferred patients with newly diagnosed multiple myeloma (ASH 2025) - P3 | "Patients in the DRd arm will receive SCdaratumumab and oral lenalidomide as detailed above plus dexamethasone 40 mg (20 mg if age >75years or BMI <18.5) orally on D1, D8, D15, and D22. The key secondaryendpoint is overall survival; other secondary endpoints include, overall and sustained MRD negativityrate, duration of MRD negativity, objective response rate, complete response rate, time to response,duration of response and complete response, PFS by investigator, PFS2 (time to second objective diseaseprogression by investigator), pharmacokinetics, immunogenicity, and health-related quality of life(HRQOL) measures. Biomarker data, healthcare resource utilization data, and additional HRQOLmeasures will be collected as part of exploratory endpoints.ResultsN/A ConclusionsN/A"

Clinical • Combination therapy • P3 data • Hematological Malignancies • Multiple Myeloma • Transplantation

A phase 2 trial of teclistamab plus daratumumab combination therapy for high-risk smoldering multiple myeloma: First pre-planned analysis (the REVIVE Study) (ASH 2025) - P2 | "Introduction Recently, subcutaneous (SC) daratumumab monotherapy (compared to active monitoring) has beenfound to significantly lower the risk of progression from high-risk smoldering multiple myeloma (SMM) toactive multiple myeloma (MM) or death and prolong overall survival (the AQUILA Trial)...One hour prior to the first step updose of Tec, patients receive a single dose of tocilizumab 8 mg/kg to prevent cytokine release syndrome(CRS)...Nounexpected safety concerns were identified. At the meeting, we will present updated data on clinicalefficacy including preliminary data on durability of MRD negative responses, i.e. sustained MRD negativity(clinicaltrials.gov NCT06100237)."

Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Pneumonia • Respiratory Diseases • Smoldering Multiple Myeloma

Daratumumab for immune-mediated thrombotic thrombocytopenic purpura (iTTP): Results from the international, multicenter darttp study (ASH 2025) - "Patients had received a median of 3 (IQR 2)previous IST, including rituximab (100%), bortezomib and mycophenolate (25% each), cyclosporine andcyclophosphamide (20% each), azathioprine (15%), vincristine (10%), obinutuzumab, ofatumumab, andsplenectomy (5% each). Seventeen patients received daratumumab in the remission phase (i.e., forADAMTS13 relapse or intolerance to other IST), while 3 during an acute episode (plasma-based therapyand caplacizumab ongoing in 3 and 2 patients, respectively)...Disease duration, previous IST used, daratumumab schedule, ordemographics did not correlate with response or its duration...A patient not receiving acyclovir had a grade 2 zoster skininfection 3 months after her last daratumumab infusion. in this study, daratumumab warranted rapid ADAMTS13 remission in 75% of iTTP patientsrefractory or intolerant to rituximab and other conventional IST... in this study, daratumumab warranted rapid ADAMTS13 remission in 75% of iTTP patientsrefractory..."

Clinical • Cardiovascular • Dermatology • Hematological Disorders • Herpes Zoster • Thrombocytopenic Purpura • CD20

Daratumumab plus cyclophosphamide, bortezomib and dexamethasone in newly diagnosed patients with light-chain amyloidosis: Interim analysis from an Italian, multicenter, retro-prospective real-world experience (ASH 2025) - "Few real-world studies assessed Daratumumab alone or withbortezomib or lenalidomide; however, data on its combination with CyBorD outside clinical trials remainlimited...All patients received "CyBor_Dq" regimenupfront (subcutaneous bortezomib 1.3 mg/m², cyclophosphamide 300 mg/m² orally or IV, anddexamethasone 40 mg orally or IV weekly for six 28-day cycles, plus subcutaneous Daratumumab 1800mg—weekly in cycles 1-2, every two weeks in cycles 3-6, then monthly up to 24 cycles or progression—ina real-world setting)...The challenge is to find earlypredictors of treatment response and improve patient outcomes. Additional follow-up data are needed toconfirm these initial results and guide the development of future personalized treatment approaches."

Clinical • Real-world • Real-world evidence • Amyloidosis • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Pulmonary Disease • Renal Disease • Thrombocytopenia

Anti-CD38 immunotherapy assay and monitoring in patients with multiple myeloma: A monocentric pilot study (ASH 2025) - "In hematology, therapeutic response to rituximab has been correlated withserum drug concentration in several studies ( 1998). To date, monitoring of anti-CD38 in patients withMM during maintenance therapy and its correlation with therapeutic response were not explored.We present a study assessing (1) time intra-individual variability measured with a new available assay tomonitor daratumumab concentrations in cohort 1, and (2) association between daratumumab serumconcentrations and clinical response in MM patients in cohort 1 and 2.MethodsWe conducted a monocentric biobank observational study including patients with MM receivingdaratumumab (subcutaneous fixed dose, 1800mg) -based regimens...Therapeutic monitoring of daratumumab in patients treated forMM could thus help to predict the response to treatment and/or could help physicians to optimize timeinterval between injections. Further larger multicenter studies are needed to confirm these results."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Bowel Disease • Multiple Myeloma • Rheumatology

Characterizing a racially diverse cohort of patients with AL amyloidosis treated with dara-VCD (ASH 2025) - "In thepivotal ANDROMEDA study, which established daratumumab plus bortezomib, cyclophosphamide, anddexamethasone (Dara-VCD) as the standard of care, only 6 of 194 patients in the Dara-VCD arm (3.1%)self-identified as Black (Kastritis 2024)...Future analyses will examine longitudinaloutcomes, including organ response and overall survival. These data provide a critical resource forunderstanding disease presentation and early treatment response in a racially diverse population,supporting the generalizability of clinical trial findings and informing future efforts to improve equity inamyloidosis care and research."

Clinical • Amyloidosis • Hematological Malignancies

Real-world outcomes of standard and modified daratumumab-based therapy in AL amyloidosis: A cohort study from a multidisciplinary program in south India (ASH 2025) - "In India, these challengescontribute to diagnostic inertia and underutilization of effective therapies, resulting in late-stagepresentation and poorer outcomes.Daratumumab, a CD38-directed monoclonal antibody, has demonstrated high efficacy in newlydiagnosed AL Amyloidosis when combined with Bortezomib, Cyclophosphamide, and Dexamethasone(Dara-VCD), as shown in the ANDROMEDA trial...In this real-world cohort from a resource-limited setting, daratumumab-based regimens significantlyimproved hematologic and cardiac responses in newly diagnosed AL Amyloidosis. Importantly, modified-dose Daratumumab showed comparable efficacy to full-dose regimens, offering a pragmatic option incost-constrained environments. These findings support broader access to Daratumumab and underscorethe feasibility of dose-adapted strategies in LMICs, especially in advanced-stage disease where outcomesremain suboptimal."

Clinical • Real-world • Real-world evidence • Amyloidosis • Cardiovascular • Hematological Disorders • Infectious Disease • Septic Shock

Quality of life in multiple myeloma: A scoping review (ASH 2025) - "Parenteral treatments for NDMM includeddaratumumab (dara) –bortezomib–melphalan–prednisone (D-VMP), bortezomib–melphalan–prednisone(VMP), carfilzomib (K), and intravenous/subcutaneous daratumumab monotherapy or combinationregimens. Oral treatments comprised ixazomib–dexamethasone with or without cyclophosphamide(ICd/Id), melphalan–prednisone–lenalidomide (MPR), and melphalan–prednisone–thalidomide(MPT)...The PI /IMiDs±others group showed a wide and variable range of changes, from -9.85 to12.8 (0–6 months), -2.99 to 4.35 (6–12 months), -6 to 1.95 (12–24 months), and -12.6 to 3.09 (>24 months).Two observational studies [PI/IMiDs regimens, V-dexamethasone (d), Rd, and Pomalidomide-d] showed astable but declined trend with -8.5 to -4.3 (6-12 months).ConclusionIn TIE NDMM, novel agents showed consistent trends of QoL improvement during induction, with oralregimens offering more stable outcomes during maintenance...While RRMM patients demonstrate poorer QoL score..."

HEOR • Review • Hematological Malignancies • Multiple Myeloma

Subcutaneous daratumumab at home is a safe and effective procedure allowing active treatment of frail patients with multiple myeloma (ASH 2025) - "Among the 7 pts in 1st linepotentially eligible for transplant (age < 70 years), 4 were transplanted, 1 is in evaluation and 2 refusedthe procedure shifting to maintenance with lenalidomide. Median overall survival from the start of home management was 35.3months (95%CI 18.5 – 59.2). Treatment at home with sc-dara in frail pts with MM is feasible and safe alsoin different geographical settings: it makes possible a curative approach frontline and in advancedphases also in pts otherwise excluded by best available therapies or forced to long periods ofhospitalization"

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Hepatology • Infectious Disease • Leukemia • Multiple Myeloma • Musculoskeletal Diseases • Orthopedics • Pneumonia • Respiratory Diseases

A Phase 2/3, multicenter, randomized, open-label study evaluating the efficacy and safety of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in frailer transplant-ineligible patients with newly diagnosed multiple myeloma (ASH 2025) - P2/3 | "Triplet or quadruplet regimens, such asdaratumumab, lenalidomide, and dexamethasone (DRd) or anti-CD38 monoclonal antibodies +bortezomib, lenalidomide, and dexamethasone are considered standard of care (SoC) in transplant-ineligible (TI) patients...The studywill include patients with an International Myeloma Working Group (IMWG) Myeloma Frailty Index Scoreof ≥1 (intermediate-fitness to frail).In the Phase 2 part of the study, patients will be randomized to receive 1 of 3 dose levels of etentamig (IV)every 4 weeks (Q4W) with 1800 mg of daratumumab (subcutaneous) every week (cycles 1–2), Day 1 andDay 15 (cycles 3–6), and Q4W (cycle 7+)...InPhase 3, measurable residual disease negativity (10−5 threshold) and progression-free survival are dualprimary endpoints. Approximately 54 sites across the United States, Canada, Japan, France, Norway, andSpain will participate in Phase 2, and additional countries contributing approximately 101 sites will beadded for Phase 3."

Clinical • P2/3 data • Hematological Malignancies • Multiple Myeloma • Transplantation

Impact-AL: A phase 2 clinical trial of teclistamab and daratumumab in previously untreated AL amyloidosis (ASH 2025) - "Despite advances with daratumumab plus bortezomib-cyclophosphamide-dexamethasone(Dara-VCd) initial therapy, nearly half of the patients do not achieve hematologic complete response(heme-CR) by 6 months, highlighting the need for additional effective therapy...Principal exclusion criteria are NT-proBNP >8500 pg/mL, New York Heart Association IIIb or IVfunctional class, planned auto-transplant within 6 months, and concomitant multiple myeloma (exceptfor an isolated involved/uninvolved serum FLC ratio>100).Patients will receive subcutaneous teclistamab and daratumumab-hyaluronidase for six 28-day cycles.Teclistamab will follow the approved step-up dosing schedule, followed by treatment dosing.Daratumumab will be administered as per standard dosing...Clinical efficacy will be further evaluatedthrough rate and depth of organ response in heart, liver, and kidneys, major organ deterioration-progression free survival (MOD-PFS), and overall survival. Exploratory analysis..."

Clinical • P2 data • Amyloidosis • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Inflammation • Multiple Myeloma

A phase 2 Study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: The IFM2021-01 teclille trial, cohort a (ASH 2025) - P2 | "The IFM2021-01 trial is a phase 2study evaluating the doublets teclistamab-daratumumab (Cohort A) and teclistamab-lenalidomide(Cohort B) in frontline transplant-ineligible patients...Daratumumab SC (1800 mg) was given weekly in Cycles 1–2, every 2 weeks inCycles 3–6, and every 4 weeks thereafter...Conclusions. IFM2021-01 Cohort A demonstrates that an "all-antibody–based" doublet regimen ofteclistamab and daratumumab is highly effective and well-tolerated in elderly patients with NDMM, withdeep responses, high MRD negativity, and a favorable safety profile."

Clinical • Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia

Minimal residual disease dynamics in post-transplant patients with newly diagnosed multiple myeloma who received daratumumab plus lenalidomide versus lenalidomide alone as maintenance therapy in the auriga study (ASH 2025) - P3 | "In the phase 3 AURIGAstudy (NCT03901963), adding subcutaneous daratumumab (DARA SC) to R maintenance (D-R) improvedMRD-neg conversion (conv) and PFS in anti-CD38–naïve pts who were MRD pos post-ASCT. D-R maintenance provided benefit via increased MRD-neg rates, notably at 10–6, asevidenced by a >2.5-fold MRD-neg conv rate and an almost 10-fold sustained MRD-neg rate vs Rmaintenance alone. Pts achieving MRD-neg conv at 10–6 were less likely to have MRD-pos recurrence thanpts who attained MRD-neg conv at 10–5 only (but not at 10–6), and D-R pts were less likely to developMRD-pos recurrence than R pts. Pts who achieved deeper MRD neg (10–6) or sustained MRD neg (10–5 or10–6) showed a trend toward improved PFS vs pts with MRD-pos recurrence or who never achieved MRDneg, with few PD events observed in pts with MRD-neg conv."

Clinical • Minimal residual disease • Post-transplantation • Residual disease • Hematological Malignancies • Multiple Myeloma • Transplantation

Understanding the Impact of Cost-Effectiveness Evaluations on Drug Pricing in Japan: A Case Study of Oncology Therapies (ISPOR-EU 2025) - "Eight oncology therapies (Kymriah, Epikinly, Cabometyx, Retevmo, Enhertu, Polivy, Darzquro, Padcev) have completed HTA reports published on the C2H platform. Japan's HTA system actively uses CEA to reassess high-cost oncology drugs. Although several products faced price revisions, the scope and consistency of these impacts vary. Manufacturers must understand the evolving regulatory, reimbursement, and HTA interplay to navigate Japan's market successfully."

Case study • Clinical • Cost effectiveness • HEOR • Pricing

Unprecedented results from the Phase 3 MajesTEC-3 study support TECVAYLI plus DARZALEX FASPRO as a potential standard of care as early as second line for patients with relapsed/refractory multiple myeloma (PRNewswire) - "Results show an 83% reduction in the risk of disease progression or death compared to standard regimens at nearly three-years follow-up (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001). Ninety-one percent of patients who were progression-free at six months remained progression-free at three years....TECVAYLI plus DARZALEX FASPRO showed higher rates of complete response (≥CR) (81.8% vs. 32.1%; odds ratio [OR], 9.56; 95% CI, 6.47-14.14), overall response (89.0% vs. 75.3%; OR, 2.65; 95% CI, 1.68-4.18) and MRD-negativity (58.4% vs. 17.1%; OR, 6.78; 95% CI, 4.53-10.15, P<0.0001; evaluable rate of 89.3% vs. 63.0%) at three-years follow-up. OS favored TECVAYLI plus DARZALEX FASPRO (HR, 0.46; 95% CI, 0.32-0.65; P<0.0001) across all prespecified subgroups. At three-years, OS rates were 83.3% and 65.0%, respectively."

P3 data • Multiple Myeloma

CARTITUDE-2: A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • 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 | Active, not recruiting | Sponsor: University of Turin, Italy | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Trends in Medicare Spending on Multiple Myeloma Drugs, 2013 to 2021 (ASH 2023) - "Lenalidomide (68%) and pomalidomide (52%) had the largest price increases...Spending on the three myeloma drugs approved via accelerated approval but subsequently withdrawn from the market following confirmatory trials was $85,328,842 (melflufen: $859,764, belantamab: $31,749,711, panobinostat: $52,719,367). Spending data demonstrate prescriber sensitivity to route-of-administration-specific toxicities: almost no intravenous bortezomib was prescribed, and in 2021, >60% of patients on daratumumab received subcutaneous Darzalex Faspro. Second-in-class anti-CD38 antibody isatuximab offered daratumumab little competition (623 beneficiaries received isatuximab vs 20,573 receiving daratumumab)...Our analysis underscores why the Inflation Reduction Act—and its key provisions of inflationary rebates and Medicare price negotiation—are vital to rein in Medicare spending. Generic competition, particularly for lenalidomide and bortezomib, whose patents expired recently, may also..."

Medicare • Reimbursement • US reimbursement • Hematological Malignancies • Multiple Myeloma • Oncology

ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Massachusetts General Hospital

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Home Based Daratumumab Administration for Patients With Multiple Myeloma (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Thomas Jefferson University | Phase classification: P1 ➔ P4

Phase classification • Hematological Malignancies • Multiple Myeloma • Oncology

Teclistamab-Daratumumab in AL Amyloidosis (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Suzanne Lentzsch, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Amyloidosis

FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis (FDA) - "Efficacy was evaluated in ANDROMEDA (NCT03201965), an open-label, randomized, active-controlled trial in 388 patients with newly diagnosed AL amyloidosis with measurable disease and at least one affected organ according to consensus criteria....The approval was based on major organ deterioration progression free survival (MOD-PFS; defined as the duration from the date of randomization to either hematologic progression, major organ deterioration, or death, whichever occurred first), and overall survival (OS)....The recommended dose is 1,800 mg daratumumab and 30,000 units hyaluronidase-fihj administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to the recommended schedule in combination with VCd."

FDA approval • Amyloidosis

Real-World Multicenter Data of Venetoclax Use in Multiple Myeloma with t(11-14). Time to Consider It Again (ASH 2024) - "Carfilzomib was administrated intravenously at 56mg/m2 once or twice a week, or at 70 mg/m2 weekly according to each center, and daratumumab subcutaneously at 1800mg weekly on cycle 1-2, every 2 weeks on cycle 3-6 and monthly since cycle 7.Results : 46 pts treated between July 2019 and July 2024 were included. Forty-one percent were treated with a combination of VEN, PI and dexamethasone (DXM), 26% with VEN, anti-CD38 and DXM, 24% with VEN +/- DXM and 9% with other combination included VEN (2 patients were treated with IP and anti-CD38 and VEN, 2 patients with pomalidomide and VEN)...Most of patient had aggressive disease, 72% were refractory to lenalidomide and 63% were refractory to anti-CD38 at start of VEN.With a median follow up of 11 months (IQR 4-19), the median progression free survival was 16 months, and the median overall survival was 26 months with no significant difference between VEN as monotherapy or in combination...Despite the negativity of phase 3..."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Multiple Myeloma • Oncology • Thrombocytopenia • BCL2