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

Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. (ASCO 2025) - P3 | "Funded by Johnson & Johnson Clinical Trial Registration Number: NCT03652064 Background: After readout of the PERSEUS and CEPHEUS trials, daratumumab-based therapy + VRd is emerging as the standard of care in NDMM treatment. In CEPHEUS TIE pts, the ≥CR rate was 80.6% and overall MRD neg rate (10−5) was 60.4%, with ~50% of pts sustaining MRD neg for ≥1 y. Nearly 70% of pts were alive and progression free at 4.5 y. These subgroup data reinforce the strong efficacy of DVRd in the TIE population."

Clinical • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Transplantation

Subcutaneous daratumumab plus carfilzomib and dexamethasone (D-Kd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who received previous daratumumab treatment: LYNX study. (PubMed, Leuk Lymphoma) - P2 | "No new safety concerns were identified. Future studies are needed to optimize daratumumab-based regimens for patients with RRMM who have prior daratumumab exposure."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

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

Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma. (PubMed, N Engl J Med) - P3 | "Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.)."

Journal • Cardiovascular • Hematological Malignancies • Hypertension • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS study. (PubMed, Nat Med) - P3 | "This phase 3 trial evaluated subcutaneous daratumumab plus VRd (D-VRd) in patients with transplant-ineligible NDMM or for whom transplant was not planned as the initial therapy (transplant deferred). The present study supports D-VRd quadruplet therapy as a new standard of care for transplant-ineligible or transplant-deferred NDMM. ClinicalTrials.gov registration: NCT03652064 ."

Journal • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

LINKER-SMM2: A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) (clinicaltrials.gov) - P3 | N=270 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Smoldering Multiple Myeloma

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, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. (PubMed, N Engl J Med) - P3 | "The addition of subcutaneous daratumumab to VRd induction and consolidation therapy and to lenalidomide maintenance therapy conferred a significant benefit with respect to progression-free survival among transplantation-eligible patients with newly diagnosed multiple myeloma. (Funded by the European Myeloma Network in collaboration with Janssen Research and Development; PERSEUS ClinicalTrials.gov number, NCT03710603; EudraCT number, 2018-002992-16.)."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia • Transplantation

Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | N=75 ➔ 17

Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology • TP53

Elranatamab in Combination with Daratumumab for Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Phase 3 Magnetismm-5 Study Safety Lead-in Cohort (ASH 2022) - P2, P3 | "Pts must have received ≥3 prior lines of anti-MM therapy, including lenalidomide and a proteasome inhibitor...In Part 2 of MagnetisMM-5, pts will be randomized 1:1:1 to receive SC elranatamab monotherapy, or SC elranatamab + SC daratumumab, or SC daratumumab + oral pomalidomide + oral dexamethasone. SC elranatamab + SC daratumumab demonstrated promising early responses with a manageable safety profile in pts with RRMM, consistent with the SC elranatamab monotherapy results from MagnetisMM-3. No DLTs were observed, and no pts experienced ICANS or ≥G3 CRS with the 2 step-up priming regimen for elranatamab. These results support continued development of elranatamab in combination with daratumumab for pts with RRMM."

Clinical • Combination therapy • P3 data • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Transplantation

Johnson & Johnson…announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) (PRNewswire) - "The pivotal Phase 3 CEPHEUS study (NCT03652064) evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) in NDMM patients who were ineligible for ASCT or deferred ASCT as initial therapy....Approval marks the twelfth indication for DARZALEX FASPRO and fifth in the newly diagnosed setting..."

FDA approval • Multiple Myeloma

Updated Efficacy and Safety Results of Subcutaneous Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Therapy in Newly Diagnosed Multiple Myeloma After Transplant: AURIGA Study (IMS 2025) - P3 | "Updated efficacy and safety data from AURIGA continue to demonstrate the value of adding DARA SC to R maint., as evidenced by continued higher MRD-neg conversion rates and a PFS benefit, with no new safety signals observed."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Transplantation

Systemic Anti-Cancer Therapy Dose Modifications for Individuals With Duffy Null Phenotype (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Andrew Hantel, MD

New P1 trial • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

Darzalex Faspro: Regulatory approval in US for frontline multiple myeloma transplant ineligible (based on CEPHEUS trial) in 2026 (J&J) - Q4 2025 Results

FDA approval • Hematological Malignancies • Multiple Myeloma • Oncology

LINKER-MM5: A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov) - P3 | N=915 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Hematological Malignancies • Multiple Myeloma • Oncology

Daratumumab Plus Lenalidomide (D-R) Versus Lenalidomide (R) Alone As Maintenance Therapy in Newly Diagnosed Multiple Myeloma (NDMM) after Transplant: Analysis of the Phase 3 Auriga Study Among Clinically Relevant Subgroups (ASH 2024) - P3 | "Pts received 28-day cycles of R maintenance (10mg PO D1-28 [after C3, 15mg PO, if tolerated]) ± subcutaneous DARA (DARA SC; 1,800mg QW C1-2, Q2W C3-6, Q4W C7+) for up to 36 cycles or until disease progression, unacceptable toxicity, or withdrawal. Grade 3/4 TEAEs were higher for D-R vs R in Black and White pts, as well as those <65 yrs. These results demonstrate the benefit of adding DARA to R maintenance in clinically relevant subgroups of anti-CD38 naïve pts with NDMM who were positive for MRD post-ASCT."

Clinical • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Transplantation

Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma (ASH 2024) - "Lenalidomide has been shown to delay progression in patients with high-risk smoldering multiple myeloma (HR-SMM) and curative intent trials in this population with carfilzomib-based therapy and stem cell transplantation have shown deep responses but generated concern for treatment-related toxicities and mortality...Treatment with D-RVD is 2 years (24, 28 day cycles) with daratumumab subcutaneous (SQ) per standard dose and schedule, bortezomib 1.3mg/m2 SQ on days 1, 8, 15 for cycles 1-6 then biweekly until completion of cycle 24, and lenalidomide 25mg on days 1-21 for cycles 1-6 followed by 15mg d1-21 from cycles 7-24 with low dose dexamethasone...Stem cell collection was successful in all eligible patients with an average stem cell yield of 4.89 x 106 CD34+ cells/kg, collected over median of 1 day. Conclusions : D-RVD in HR-SMM demonstrates significant activity, including a 98% ORR and high rates of MRD-negative disease, preventing progression to overt MM, with..."

P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Respiratory Diseases • Smoldering Multiple Myeloma • CD34

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 | "In TE NDMM, nearly two-thirds of pts treated with DVRd induction and DR maint achieved ≥12-mo sustained MRD neg, associated with >95% 48-mo PFS rate. Moreover, ≥24-mo sustained MRD neg rates with DVRd were 2.5 times as high as VRd, and FHR incidence was halved with DVRd vs VRd. Collectively, these data further support the PERSEUS regimen as standard of care for TE NDMM."

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

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

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

Subcutaneous daratumumab (DARA SC) versus active monitoring in patients (pts) with high-risk smoldering multiple myeloma (SMM): Randomized, open-label, phase 3 AQUILA study. (ASCO 2022) - P3 | "The study completed enrollment on May 6, 2019; 390 pts have been randomly assigned to DARA SC or active monitoring. The primary efficacy analysis will be performed after approximately 165 PFS events have been observed."

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

Ixazomib and daratumumab without dexamethasone (I-Dara) in elderly frail RRMM patients: A multicenter phase 2 study (IFM 2018-02) of the Intergroupe Francophone du Myélome (IFM). (ASCO 2022) - P2 | " Ixa-Dara naïve RRMM patients received oral Ixazomib (4 mg: days 1, 8, 15), IV Daratumumab (16 mg/kg; days 1, 8, 15, 22, cycles 1-2; days 1, 15, cycles 3-6; days 1, cycles 7+) and IV Methylprednisolone before Daratumumab (100 mg at day 1, 8, cycle 1 and then 60 mg)...Thirty-three patients (60%) were previously exposed to bortezomib, 37 (67%) were previously exposed to lenalidomide (Len) and 20 (36 %) were refractory to Len... In this elderly frail population Ixa-Dara is a feasible combination with favorable efficacy profile even in Len refractory and HR cytogenetic patients. Early toxicity remains a concern in this population eventhough more manageable with Dara SC."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Geriatric Disorders • Hematological Disorders • Hypertension • Infectious Disease • Multiple Myeloma • Respiratory Diseases • Septic Shock • Thrombocytopenia

[VIRTUAL] Phase III Study of Daratumumab/rhuph20 (nsc- 810307) + Lenalidomide or Lenalidomide As Post-Autologous Stem Cell Transplant Maintenance Therapyin Patients with Multiple Myeloma (mm) Using Minimal Residual Disease Todirect Therapy Duration (DRAMMATIC study): SWOG s1803 (ASH 2020) - "A total of 1100 pts will be accrued to initial step 1 to allow for a 5% drop out and allow 950 pts for the second randomization. As of Aug 1, 171 pts are enrolled for screening among whom 133 have been randomized."

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

Final analysis of the phase 3 non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. (PubMed, Haematologica) - P3 | "In the primary analysis of the phase 3 COLUMBA study, daratumumab by subcutaneous administration (DARA SC) demonstrated non-inferiority to intravenous administration (DARA IV) for relapsed or refractory multiple myeloma (RRMM). In summary, DARA SC and DARA IV continue to demonstrate similar efficacy and safety, with a low rate of infusion-related reactions (12.7% vs 34.5%, respectively) and shorter administration time (3-5 minutes vs 3-7 hours) supporting DARA SC as a preferable therapeutic choice. ClinicalTrials.gov Identifier: NCT03277105."

Head-to-Head • Journal • P3 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

Teclistamab in Combination with Subcutaneous Daratumumab and Lenalidomide in Patients with Multiple Myeloma: Results from One Cohort of MajesTEC-2, a Phase1b, Multicohort Study (ASH 2022) - P1b | "Introduction: Teclistamab (tec) is an off-the-shelf, B-cell maturation antigen (BCMA) × CD3 bispecific antibody that redirects CD3+ T cells to mediate T-cell activation and subsequent lysis of BCMA-expressing multiple myeloma (MM) cells. Tec-dara-len was well tolerated, with a safety profile consistent with tec or dara-len individually. Promising ORR supports the potential for this combination to have enhanced early disease control through the addition of tec. These data warrant further investigation."

Clinical • Combination therapy • P1 data • Bone Marrow Transplantation • CNS Disorders • Cough • Fatigue • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Insomnia • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Renal Disease • Respiratory Diseases • Sleep Disorder • Transplantation • IFNG • IL6 • PD-1 • TNFA