DARZALEX FASPRO®  is indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone (DARZALEX FASPRO® + VRd) for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant.

DARZALEX® Perseus Logo

For the treatment of newly diagnosed multiple myeloma1:

Give your transplant-eligible patients a better chance at experiencing improved outcomes with DVRd vs VRd1,2

60% reduction in the risk of disease progression or death with DVRd vs VRd alone, after a median follow-up of 47.5 months (HR=0.40; 95% CI: 0.29, 0.57; P<0.0001; mPFS not reached in either arm).1,2*

*Median follow-up was 47.5 months in the DVRd and VRd group (range: 0.0-54.4 months).2

DARZALEX FASPRO® + VRd: For the treatment of transplant-eligible patients with newly diagnosed multiple myeloma1

The PERSEUS trial: Approval of DARZALEX FASPRO® for transplant-eligible patients with newly diagnosed multiple myeloma was based on the results from a phase 3 randomized, multicenter, open-label trial.1,2

Study Design chartStudy Design chart
#The trial was not designed to isolate the effect of DARZALEX FASPRO® in the maintenance phase of treatment. The efficacy of DARZALEX FASPRO® + R for maintenance has not been established.1

Primary endpoint was progression-free survival (PFS) based on International Myeloma Working Group (IMWG) criteria.1

Key secondary endpoints included overall response rate (ORR), minimal residual disease (MRD) negativity rate (next-generation sequencing [NGS];10-5).1,2**

Is your patient a potential fit for DARZALEX FASPRO® + VRd?

Review patient profile
ASCT=autologous stem cell transplant; CI=confidence interval; CR=complete response; d=dexamethasone (d); D=DARZALEX FASPRO® (D); DR=DARZALEX FASPRO® (D) + lenalidomide (R); DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); ECOG PS=Eastern Cooperative Oncology Group Performance Status; HR=hazard ratio; IMWG=International Myeloma Working Group; ISS=International Staging System; IV=intravenous; mPFS=median progression-free survival; MRD=minimal residual disease; NDMM=newly diagnosed multiple myeloma; NGS=next-generation sequencing; ORR=overall response rate; PFS=progression-free survival; PO=by mouth; QW=weekly; Q2W=every 2 weeks; R=lenalidomide (R); SC=subcutaneous; V=bortezomib (V); VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
†Within 12 weeks of ASCT, and when engraftment was complete.1
‡Stratified by ISS stage and cytogenetic risk.2
§DARZALEX FASPRO® 1,800 mg co-formulated with rHuPH20 (2,000 U/mL).1
||On the days of DARZALEX FASPRO® injection, the dexamethasone dose was administered orally or intravenously as a pre-injection medication.1
After Week 16, patients underwent stem cell mobilization, high-dose chemotherapy, and ASCT.1
**MRD negativity rate was defined as the proportion of patients who achieved both MRD negativity and ≥CR. MRD was assessed using a next-generation sequencing assay (clonoSEQ).1

In the treatment of transplant-eligible patients with newly diagnosed multiple myeloma1:

Baseline demographics and disease characteristics were similar between the 2 treatment groups2,3

Adverse reactions chart
Patient CharacteristicsDARZALEX FASPRO® + VRd (n=355)VRd (n=354)
Median age (y)6159
Age category (%)
<50 yrs1515
≥50 and <65 yrs5860
≥65 yrs2725
ECOG PS† (%)
06265
13231
255
300
ISS disease stage‡ (%)
I5250
II3235
III1514
Cytogenetic profile (%)
Standard risk7475
High risk§2122
Indeterminate43
Patient icon

The PERSEUS trial included patients of various ages, performance status, and cytogenetic abnormalities2

CI=confidence interval; DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); ECOG PS=Eastern Cooperative Oncology Group Performance Status; FISH=fluorescence in situ hybridization; HR=hazard ratio; ISS=International Staging System; mPFS=median progression-free survival; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
†ECOG PS is scored on a scale from 0 to 5, with 0 indicating no symptoms and higher scores indicating increasing disability.2
‡ISS disease stage was based on the combination of serum β2-microglobulin and albumin levels. Higher stages indicate more advanced disease.2
§Cytogenetic risk was based on fluorescence in situ hybridization (FISH); high-risk cytogenetics were defined as the presence of one of the following abnormalities: del(17p), t(4;14), or t(14;16).1,2

In the treatment of transplant-eligible patients with newly diagnosed multiple myeloma1:

Frontline DARZALEX FASPRO® + VRd significantly reduced the risk of progression or death in patients vs VRd alone after a median follow-up of 47.5 months1,2
Progression Free Survival chartProgression Free Survival chart
The median time to reach post-transplant consolidation was 9.9 months in the DVRd arm (range: 0.5-18.5 months).1
reduction in the risk of disease progression or death with DARZALEX FASPRO® + VRd vs VRd alone (HR=0.40; 95% CI: 0.29-0.57; P<0.0001)1†§
These results are based on the full treatment regimen and include investigational maintenance of DARZALEX FASPRO® + R post-transplant consolidation. The trial was not designed to isolate the effect of DARZALEX FASPRO® in the maintenance phase of treatment. The efficacy of DARZALEX FASPRO® R for maintenance has not been established.1
CI=confidence interval; DR=DARZALEX FASPRO® (D) + lenalidomide (R); DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; IMWG=International Myeloma Working Group; IRC=Independent Review Committee; mPFS=median progression-free survival; MRD=minimal residual disease; PFS=progression-free survival; R=lenalidomide (R); VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
†Median follow-up was 47.5 months in the DVRd and VRd group (range: 0.0-54.4 months).2
‡Kaplan-Meier estimate.4
§Progression-free survival was by IRC assessment based on IMWG criteria.1

In the treatment of transplant-eligible patients with newly diagnosed multiple myeloma1:

Overall response rates through post-transplant consolidation for frontline DARZALEX FASPRO® + VRd vs VRd alone1†
Response Rate graphResponse Rate graph
The median time to reach post-transplant consolidation was 9.9 months in the DVRd arm (range: 0.5-18.5 months)1
44.5% of patients achieved ≥CR with DVRd, vs 34.7% with VRd alone1
CI=confidence interval; CR=complete response; DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; mPFS=median progression-free survival; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
*Based on intent-to-treat population.1

In the treatment of transplant-eligible patients with newly diagnosed multiple myeloma1:

MRD negativity rates through post-transplant consolidation at 10-5 threshold for frontline DARZALEX FASPRO® + VRd vs VRd alone1†
Overall MRD Negativity 10-5
Overall MRD Negativity 10-6
CI=confidence interval; CR=complete response; DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; mPFS=median progression-free survival; MRD=minimal residual disease; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
†MRD negativity rate was defined as the proportion of patients who achieved both MRD negativity and ≥CR. MRD was assessed using a next-generation sequencing assay (clonoSEQ).1
‡Based on intent-to-treat population who achieved MRD negativity (10-5) through post-transplant consolidation and ≥CR at any time during the study.1
§Patients who achieved MRD negativity (threshold of 10-5) and ≥CR through post-transplant consolidation.1

In the treatment of transplant-eligible patients with newly diagnosed multiple myeloma1:
Demonstrated safety profile through post-transplant consolidation for frontline DARZALEX FASPRO® + VRd1
Adverse reactions reported in ≥10% of patients who received DVRd through post-transplant consolidation1
Adverse reactions chart
DVRd (n=351)VRd (n=347)
Adverse reactionAll grades (%)Grades 3 or 4 (%)All grades (%)Grades 3 or 4 (%)
Peripheral neuropathy†525544
Paraesthesia11<1#11<1#
Fatigue‡353#375#
Edema‡221211#
Pyrexia212#223#
Upper respiratory tract
infection§		321#262#
Pneumonia||149106**
Constipation312#302#
Diarrhea233#255#
Nausea161#121#
Abdominal pain‡110120
Musculoskeletal pain‡261#231#
Muscle spasm1209<1#
Insomnia262#122#
Rash†253#315
Hepatotoxicity166#165
Cough‡12<1#80
The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash1
Select laboratory abnormalities (≥30%) that worsened from baseline in patients who received DVRd through post-transplant consolidation1
Laboratory Abnormalities chart
DVRd (n=351)††VRd (n=346)††
Laboratory abnormalityAll grades (%)Grades 3 or 4 (%)All grades (%)Grades 3 or 4 (%)
Hematology
Decreased platelets89347825
Decreased lymphocytes87696943
Decreased leukocytes78475622
Decreased neutrophils67524734
Decreased hemoglobin397436
Chemistry
Increased alanine aminotransferase (ALT)527485
Decreased sodium405255
Increased alkaline phosphatase390361
Decreased potassium306243
In patients who received DVRd1:
  • 37% experienced serious adverse reactions
  • >5% experienced most frequent serious adverse reactions: pneumonia (6%)
  • 1.7% experienced fatal adverse reactions
  • 2% experienced permanent treatment discontinuation due to an adverse reaction
    • An adverse reaction which resulted in permanent discontinuation of DVRd in more than 1 patient included sepsis
ALT=alanine aminotransferase; CI=confidence interval; DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; mPFS=median progression-free survival; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
†Peripheral neuropathy includes neuropathy peripheral, peripheral motor neuropathy, peripheral sensorimotor neuropathy, and peripheral sensory neuropathy.1
‡Includes other related terms.1
§Upper respiratory tract infection includes fungal pharyngitis, h1n1 influenza, influenza, influenza like illness, laryngitis, nasopharyngitis, oral candidiasis, oropharyngeal candidiasis, parainfluenzae virus infection, pharyngitis, respiratory moniliasis, respiratory syncytial virus infection, respiratory tract infection, respiratory tract infection viral, rhinitis, rhinovirus infection, sinusitis, tonsillitis, upper respiratory tract infection, viral tonsillitis, and viral upper respiratory tract infection.1
||Pneumonia includes bronchopulmonary aspergillosis, lower respiratory tract infection, pneumocystis jirovecii pneumonia, pneumonia, pneumonia bacterial, pneumonia cytomegaloviral, pneumonia influenzal, pneumonia klebsiella, pneumonia legionella, and pneumonia streptococcal.1
Hepatotoxicity includes alanine aminotransferase increased, aspartate aminotransferase increased, hepatic cytolysis, hepatic failure, hepatic function abnormal, hepatoxicity, hyperbilirubinemia, hypertransaminasemia, and liver disorder.1
#Only Grade 3 adverse reactions occurred.1
**Fatal adverse reactions included pneumonia: n=1 (0.3%) in the VRd arm.1
††Based on number of patients with a baseline and post-baseline laboratory value for each laboratory test.1

Would you consider frontline DARZALEX FASPRO® + VRd for a transplant-eligible patient like Philip?

Hypothetical patientHypothetical patient

Hypothetical patient

Philip is a moderately active patient who is eligible for transplant

Age:

62 years old

Job:

Information systems manager

Biography:

  • Married; with 2 adult children
  • Enjoys going on long walks with his spouse and pet dog
  • Actively manages his health and treatment plan

Newly diagnosed and eligible for a transplant

Transplant eligibility of an individual patient is determined based on evaluation by the treating physician.

Clinical condition and disease presentation
Book icon

ISS disease stage: I

Person icon

ECOG PS: 1

DNA icon

Cytogenetic risk: Standard†

Additional considerations

Presents with:​

  • Mild anemia (9 g/dL)​
  • Shortness of breath

Discover frontline DVRd benefits and safety profile based on results from the PERSEUS trial

View results
CI=confidence interval; DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); ECOG PS=Eastern Cooperative Oncology Group Performance Status; FISH=fluorescence in situ hybridization; HR=hazard ratio; ISS=International Staging System; mPFS=median progression-free survival; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
†Cytogenetic risk was based on fluorescence in situ hybridization (FISH); high-risk cytogenetics were defined as the presence of one of the following abnormalities: del(17p), t(4;14), or t(14;16).1,2

References:

  1. DARZALEX FASPRO® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Sonneveld P, Dimopoulos MA, Boccadoro M, et al. Daratumumab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2024;390(4):301-313.
  3. Data on file. Janssen Biotech, Inc.
  4. Sonneveld P, Dimopoulos MA, Boccadoro M, et al. Daratumumab + bortezomib, lenalidomide, and dexamethasone (VRd) versus VRd patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation: Primary results of the PERSEUS Trial. Oral presentation at: 65th American Society of Hematology (ASH) Annual Meeting; December 9-12, 2023; San Diego, CA.

08/24 cp-446158v1