In the treatment of newly diagnosed, transplant-ineligible multiple myeloma1:

ADD TO THE MOMENTUM
WITH DARZALEX® + Rd IN FRONTLINE

Reach for a treatment that significantly extended progression-free survival vs Rd alone in a clinical trial1

PRIMARY CLINICAL RESULTS

Powerful efficacy to start the treatment journey1,3

The MAIA Study was a phase 3 global, randomized, open-label study that compared treatment with DRd (n=368) to Rd (n=369) in adult patients with newly diagnosed, transplant-ineligible multiple myeloma. Treatment was continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was PFS. Baseline demographic and disease characteristics were similar between the 2 treatment groups. The median age was 73 (range 45-90) years, with 44% of the patients ≥75 years of age.1

View MAIA Study Design

Median PFS not reached with DARZALEX® + Rd at median follow-up of ~30 months1,3*

CI=confidence interval; CR=complete response; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; MRD=minimal residual disease; NGS=next-generation sequencing; ORR=overall response rate; Rd=lenalidomide (R) + dexamethasone (d); sCR=stringent complete response.

At ~30 months: 70.6% of patients had not progressed with DRd vs 55.6% of patients in the Rd group (DRd, 95% CI: 65.0–75.4; Rd, 95% CI: 49.5–61.3)3

Depth of response: 93% ORR was achieved with DARZALEX® + Rd vs 81% with Rd alone (P<0.0001) at median follow-up of ~30 months, with 48% of patients experiencing a CR or better with DRd vs 25% with Rd alone1*

MRD rates: MRD negativity rates more than tripled with DARZALEX® + Rd at median follow-up of ~30 months vs Rd alone (24% [95% CI: 19.9%, 28.9%] vs 7% [95% CI: 4.9%, 10.5%], respectively)(P<0.0001)1*‡

  • MRD was based on a sensitivity threshold of 10-5 using an NGS assay (clonoSEQ®)

*Median follow-up was 28 months (range: 0.0-41.4 months).3

†Kaplan-Meier estimate.3

‡MRD negativity was defined as undetectable levels of multiple myeloma cells in bone marrow aspirate at any time point after randomization and before disease progression or start of subsequent therapy. In the trial, MRD was assessed by means of an NGS assay at a sensitivity threshold of 10-5 in bone marrow aspirates; samples were collected at initial trial screening, at the time of suspected CR or sCR, and thereafter at 12, 18, 24, and 30 months.3

You are now viewing the secondary endpoint of overall survival from the MAIA study. This information is not included in the current Prescribing Information and has not been evaluated by the FDA.

OVERALL SURVIVAL

At ~5 years, 66% of patients were still alive with DARZALEX® + Rd vs 53% with Rd alone2

DRd: 95% CI, 61-71; Rd: 95% CI, 47-594*†

CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; Rd=lenalidomide (R) + dexamethasone (d).

*Median follow-up was 56 months (range: 0.03-69.52 months).2,4

†Kaplan-Meier estimate.4

You are now viewing a follow-up analysis of the MAIA study. This information is not included in the current Prescribing Information and has not been evaluated by the FDA.

~5-YEAR PFS

Median progression-free survival not reached with DARZALEX® + Rd at median follow-up of ~5 years2*

CI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; Rd=lenalidomide (R) + dexamethasone (d).

*Median follow-up was 56 months (range: 0.03-69.52 months).2,4

†Kaplan-Meier estimate.4

The follow-up analysis was not adjusted for multiplicity and conclusions should not be drawn

PRIMARY SAFETY RESULTS

Safety results: median treatment duration of 25.3 months1

Most frequent adverse reactions reported in ≥20% of patients and with at least a 5% greater frequency in the DARZALEX® + Rd arm1*

Rd=lenalidomide (R) + dexamethasone (d).

*Adverse reactions that occurred with a frequency of ≥10% and <20%, and with at least a 5% greater frequency in the DARZALEX® + Rd arm were: headache, urinary tract infection, hyperglycemia, hypocalcemia, vomiting, chills, paresthesia, and hypertension.

Serious adverse reactions with a 2% greater incidence in the DRd arm compared with the Rd arm were pneumonia (DRd 15% vs Rd 8%), bronchitis (DRd 4% vs Rd 2%), and dehydration (DRd 2% vs Rd <1%).1

Treatment-emergent laboratory abnormalities1

DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).

You are now viewing a follow-up analysis of the MAIA study. This information is not included in the current Prescribing Information and has not been evaluated by the FDA.

Updated analysis of safety: ~5 years of follow-up2,4

Most frequent treatment-emergent adverse events as observed (any grade reported in ≥30% of patients and/or Grade 3/4 reported in ≥10% of patients) in the DARZALEX® + Rd arm2,4*

Median duration of study treatment was 47.5 months (range: 0.10-69.26) in the DRd group and 22.6 months (range: 0.03-69.22) in the Rd group.2

  • Cumulative Grade 3/4 infection rates were 41% for DRd vs 29% for Rd4
  • Cumulative rates of discontinuation due to TEAEs were 13% for DRd vs 23% for Rd2
  • Hematologic adverse events included in the follow-up analyses are investigator-reported TEAEs and not investigator-reported treatment-emergent laboratory abnormalities

DARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions.1

DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d); TEAE=treatment-emergent adverse event.

*Safety analysis set. TEAEs are defined as any adverse event (AE) that occurs after start of the first study treatment through 30 days after the last study treatment; or the day prior to start of subsequent antimyeloma therapy, whichever is earlier; or any AE that is considered drug related (very likely, probably, or possibly related) regardless of the start date of the event; or any AE that is present at baseline but worsens in toxicity grade or is subsequently considered drug related by the investigator.

INDICATIONS

Both DARZALEX® and DARZALEX FASPRO® are approved for a wide range of patients with multiple myeloma1,5

FDA-approved regimens in multiple myeloma1,5

Kd=carfilzomib (K) + dexamethasone (d); Pd=pomalidomide (P) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d); Vd=bortezomib (V) + dexamethasone (d); VMP=bortezomib (V) + melphalan (M) + prednisone (P); VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

DARZALEX FASPRO®

DARZALEX FASPRO®: efficacy consistent with DARZALEX®5

  • COLUMBA, a phase 3, randomized, open-label, non-inferiority, multicenter monotherapy trial that included 522 adult patients with relapsed or refractory multiple myeloma, compared DARZALEX FASPRO® vs DARZALEX®5,6
  • Co-primary endpoints were ORR, according to International Myeloma Working Group (IMWG) response criteria, and a maximum trough (Ctrough) concentration of daratumumab measured on Day 1 of Cycle 3 (each cycle is 28 days)5,6
  • Overall response rate (ORR) of DARZALEX FASPRO® monotherapy was non-inferior to DARZALEX® monotherapy (41% vs 37%, respectively)5
  • Remaining therapeutic drug concentration (maximum Ctrough) of DARZALEX FASPRO® was non-inferior to DARZALEX®6

DARZALEX FASPRO®—subcutaneous administration starting with the first dose5

Pre-medication5

Pre-medicate patients 1 to 3 hours before each dose with a histamine-1 receptor antagonist, acetaminophen, and a corticosteroid.

~3 to 5 minute injection5

Post-medication5

Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions* (ARRs).

Monitor patients for systemic ARRs, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) ARRs, immediately and permanently discontinue DARZALEX FASPRO®.5

*In clinical trials of DARZALEX FASPRO® and DARZALEX®, and in the Prescribing Information for DARZALEX®, the terms “infusion reactions” and “infusion-related reactions” were used instead of “systemic administration-related reactions.”

Benefits of DARZALEX FASPRO®

Fixed dose; no weight-based calculations5

Ready-to-use, single-dose vial5

Same dosing schedules as DARZALEX® for approved indications1,5†

†Split first dose option for DARZALEX® is not applicable to DARZALEX FASPRO®.

Formulated with hyaluronidase for subcutaneous administration5

Once-monthly dosing for DRd—a key milestone for patients to reach5

Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO®.5

Continue DARZALEX FASPRO® + Rd until disease progression or unacceptable toxicity5

DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).

*Cycle=28 days.

  • DARZALEX FASPRO® is given as a subcutaneous injection into the abdomen with a fixed dose of 1,800 mg
    daratumumab and 30,000 units hyaluronidase5
  • DARZALEX® is given as an intravenous (IV) infusion after dilution at 16 mg/kg of actual body weight1
    • To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over 2 consecutive days

See the Dosage and Administration section of the full Prescribing Information for more detail. For information concerning drugs given in combination, see manufacturers’ prescribing information.

View dosing schedule for other FDA-approved regimens for DARZALEX FASPRO®

National Comprehensive Cancer Network® (NCCN®) Category 1, Preferred

DRd: Daratumumab* (D) in combination with lenalidomide (R) and dexamethasone (d) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 1, preferred† therapeutic option for patients with newly diagnosed, transplant-ineligible multiple myeloma.‡

Learn about other NCCN-recommendended daratumumab-containing regimens

*Daratumumab includes both daratumumab (DARZALEX®) for intravenous infusion and daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for subcutaneous injection. Daratumumab and hyaluronidase-fihj for subcutaneous injection has different dosing and administration instructions compared to daratumumab for intravenous infusion.

†See nccn.org for definitions of NCCN Categories of Preference and NCCN Categories of Evidence and Consensus.

‡Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed August 19, 2021. To view the most recent and complete version of the guideline, go online to www.nccn.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

INDICATIONS & IMPORTANT SAFETY INFORMATION

DARZALEX FASPRO®

DARZALEX®

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX FASPRO® is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase, or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Other Administration Reactions

Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.

Systemic Reactions

In a pooled safety population of 898 patients with multiple myeloma (N=705) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or in combination, 9% of patients experienced a systemic administration-related reaction (Grade 2: 3.2%, Grade 3: 1%). Systemic administration-related reactions occurred in 8% of patients with the first injection, 0.3% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 140 systemic administration-related reactions that occurred in 77 patients, 121 (86%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.

Local Reactions

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.7%. The most frequent (>1%) injection-site reaction was injection-site erythema. These local reactions occurred a median of 5 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.

Neutropenia

Daratumumab may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX FASPRO® until recovery of neutrophils. In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.

Thrombocytopenia

Daratumumab may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Consider withholding DARZALEX FASPRO® until recovery of platelets.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX FASPRO® and for 3 months after the last dose.

The combination of DARZALEX FASPRO® with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women because lenalidomide, thalidomide, and pomalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, thalidomide, or pomalidomide prescribing information on use during pregnancy.

Interference With Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted.

Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX FASPRO®.

Interference With Determination of Complete Response

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein.

ADVERSE REACTIONS

In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, headache, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, upper respiratory tract infection, peripheral sensory neuropathy, constipation, pneumonia, and peripheral edema.

The most common hematology laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please click here to see the full Prescribing Information.

cp-143279v7

INDICATIONS

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:

  • In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
  • In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
  • In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor
  • In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
  • In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
  • As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX® is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions

DARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision.

When DARZALEX® dosing was interrupted in the setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: <1%) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt DARZALEX® infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX® therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®.

Interference With Serological Testing

Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type is not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.

Neutropenia and Thrombocytopenia

DARZALEX® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX® until recovery of neutrophils or for recovery of platelets.

Interference With Determination of Complete Response

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Embryo-Fetal Toxicity

Based on the mechanism of action, DARZALEX® can cause fetal harm when administered to a pregnant woman. DARZALEX® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX® and for 3 months after the last dose.

The combination of DARZALEX® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.

ADVERSE REACTIONS

The most frequently reported adverse reactions (incidence ≥20%) were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX® are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.

Please click here to see the full Prescribing Information.

cp-60862v8

INDICATIONS

DARZALEX® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:

  • In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
  • In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
  • In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
  • In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
  • In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
  • As monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

MAIA trial:

DARZALEX® (daratumumab) + Rd vs Rd alone

Phase 3 study in adult patients with newly diagnosed, transplant-ineligible multiple myeloma1,3

Primary endpoint was progression-free survival (PFS).3‡

Key secondary endpoints included percentage of patients with complete response (CR) rate, very good partial response (VGPR) rate, minimal residual disease (MRD)-negativity rate (NGS; 10-5), ORR, overall survival (OS), and safety.3

Patient characteristics: The median age was 73 years, with 44% ≥75 years of age; 92% were white; 52% were male; 34% had an ECOG performance score (PS) of 0, 50% had an ECOG PS of 1, and 17% had an ECOG PS of ≥2; 27% had ISS Stage I, 43% had ISS Stage II, and 29% had ISS Stage III disease.1

BMI=body mass index; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; IMWG=International Myeloma Working Group; ISS=International Staging System; IV=intravenous; NGS=next-generation sequencing; ORR=overall response rate; PD=progressive disease; PO=by mouth; QW=weekly; Q2W=every 2 weeks; Q4W=every 4 weeks; Rd=lenalidomide (R) + dexamethasone (d).

*On days when daratumumab was administered, dexamethasone was administered to patients in the DRd arm and served as the treatment dose of steroid for that day, as well as the required pre-infusion medication.1

†For patients older than 75 years of age or with BMI <18.5, dexamethasone was administered at a dose of 20 mg weekly.1

‡Efficacy was evaluated by PFS (based on IMWG criteria) and OS.1

References:

  1. DARZALEX® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Facon T, Kumar SK, Plesner T, et al. Overall survival results with daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: phase 3 MAIA study. Poster presented at: Virtual 26th European Hematology Association (EHA) Annual Congress; June 9-17, 2021.
  3. Facon T, Kumar S, Plesner T, et al; the MAIA Trial Investigators. Daratumumab plus lenalidomide and dexamethasone for untreated myeloma. N Engl J Med. 2019;380(22):2104-2115.
  4. Data on file. Janssen Biotech, Inc.
  5. DARZALEX FASPRO® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  6. Mateos M-V, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020;7(5):e370-e380.