Clinical Studies With DARZALEX FASPRO®

In order to understand how DARZALEX FASPRO® compared to the intravenous (IV) formulation of DARZALEX®, DARZALEX FASPRO® was evaluated as monotherapy (alone) and in different combinations.

A study confirmed that DARZALEX FASPRO® gave patients results comparable to the IV formulation of DARZALEX® (daratumumab) in treating multiple myeloma when used as monotherapy (by itself).

This study compared treatments in patients with multiple myeloma who have received at least 3 prior medicines or who did not respond to a proteasome inhibitor (PI) or an immunomodulatory agent.

522 patients

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DARZALEX FASPRO® (monotherapy)
263 patients

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DARZALEX® (monotherapy)
259 patients

41% of patients with DARZALEX FASPRO® vs 37% of patients with DARZALEX®

41% (about 4 of 10) of patients responded to treatment with DARZALEX FASPRO® compared to 37% (about 4 of 10) who responded to treatment with DARZALEX®

In the clinical study, the results were consistent, with a similar number of patients responding to both treatments

Multiple studies confirmed that DARZALEX FASPRO® is effective when used in combination with other medicines.

DARZALEX FASPRO® combination study 1: DVMP and DRd

132 patients

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With newly diagnosed multiple myeloma unable to have a transplant

DARZALEX FASPRO® + Velcade® (bortezomib) + melphalan + prednisone

67 patients

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Who received at least 1 prior medicine

DARZALEX FASPRO® + Revlimid® (lenalidomide) + dexamethasone

65 patients

88% of patients with DARZALEX FASPRO® in combination with bortezomib, melphalan, and prednisone

88% (about 9 of 10) of patients responded to treatment with DARZALEX FASPRO® in combination with Velcade® (bortezomib), melphalan, and prednisone (DVMP).

91% of patients with DARZALEX FASPRO® in combination with lenalidomide and dexamethasone

91% (about 9 of 10) of patients responded to treatment with DARZALEX FASPRO® in combination with Revlimid® (lenalidomide) and dexamethasone (DRd).

DARZALEX FASPRO® combination study 2: DPd

304 patients

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Who received at least 1 prior medicine and previously treated with Revlimid®(lenalidomide) and a PI

DARZALEX FASPRO® + Pomalyst® (pomalidomide) + dexamethasone

151 patients

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Who received at least 1 prior medicine and previously treated with Revlimid®(lenalidomide) and a PI

Pomalyst® (pomalidomide) + dexamethasone

153 patients

At a follow-up of 18 months

42% of patients treated with DPd vs 26% of patients treated with Pd alone

42% of patients treated with DARZALEX FASPRO® in combination with Pomalyst® (pomalidomide) + dexamethasone (DPd) lived without their disease getting worse vs 26% of patients treated with Pd alone

Additional studies

Take a look at these supporting studies for IV DARZALEX® (daratumumab)-based regimens that are also approved with DARZALEX FASPRO®.

The IV formulation of DARZALEX® (daratumumab) was studied in 737 patients in combination with Revlimid® (lenalidomide) + dexamethasone (Rd) vs Rd alone.

  • Patients studied had newly diagnosed multiple myeloma and could not receive a type of stem cell transplant that uses their own stem cells

737 patients

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DARZALEX® + Revlimid® + dexamethasone (Rd)
368 patients

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Rd alone
369 patients

At a median follow-up of 28 months

74% of patients with DARZALEX® + Rd

74% of patients treated with the IV formulation of DARZALEX® + Revlimid® + dexamethasone (DRd) lived without their disease getting worse vs 61% of patients treated with Rd alone.

93% of patients with DARZALEX® + Rd

About 9 of 10 patients responded to the IV formulation of DARZALEX® + Rd vs about 8 of 10 patients treated with Rd alone.

  • 47.5% of patients had a complete response* or better with DARZALEX® + Rd vs 25% with Rd alone

*This means the doctor observed no signs or symptoms of the disease as seen through imaging or other specific blood and bone marrow tests after treatment.

The IV formulation of DARZALEX® (daratumumab) was studied in 706 patients in combination with Velcade® (bortezomib) + melphalan + prednisone (VMP) vs VMP alone.

  • Patients studied had newly diagnosed multiple myeloma and could not receive a type of stem cell transplant that uses their own stem cells

706 patients

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DARZALEX® + Velcade® + melphalan + prednisone (DVMP)
350 patients

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VMP alone
356 patients

At a median follow-up of 16.5 months

75% with DARZALEX® + VMP

75% of patients treated with the IV formulation of DARZALEX® + Velcade® (V) + melphalan + dexamethasone (DVMP) lived without their disease getting worse vs 60% of patients treated with VMP alone.

91% of patients with DARZALEX® + VMP

About 9 of 10 patients responded to the IV formulation of DARZALEX® + VMP vs about 7 of 10 patients treated with VMP alone.

  • 42.6% of patients had a complete response* or better with DARZALEX® + VMP vs 24.4% with VMP alone

*This means the doctor observed no signs or symptoms of the disease as seen through imaging or other specific blood and bone marrow tests after treatment.

The IV formulation of DARZALEX® (daratumumab) was studied in 1085 patients in combination with Velcade® (bortezomib) + thalidomide + dexamethasone (VTd) vs VTd alone.

  • Patients studied were newly diagnosed with multiple myeloma and were eligible to receive a stem cell transplant
  • In this study, patients received initial (induction) therapy with either DARZALEX® + VTd or VTd alone
  • After induction, patients received high-dose chemotherapy and an autologous stem cell transplant
  • Patients received consolidation with either DARZALEX® + VTd or VTd alone. Consolidation therapy is given to help kill any cancer cells that may be left in the body after initial therapy and transplant.

1085 patients

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DARZALEX® + Velcade® + thalidomide + dexamethasone (DVTd)
543 patients

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VTd alone
542 patients

At a median follow-up of 18.8 months

91.7% of patients with DARZALEX® + VTd

91.7% of patients treated with the IV formulation of DARZALEX® + VTd lived without their disease getting worse vs 83.2% of patients treated with VTd alone.

93% of patients with DARZALEX® + VTd

About 9 of 10 patients responded to the IV formulation of DARZALEX® + VTd vs 9 of 10 patients treated with VTd alone

  • 38.8% of patients had a complete response* or better with DARZALEX® + VTd vs 26% with VTd alone

*This means the doctor observed no signs or symptoms of the disease as seen through imaging or other specific blood and bone marrow tests after treatment.

The IV formulation of DARZALEX® (daratumumab) was studied in 569 patients in combination with Revlimid® (lenalidomide) + dexamethasone (Rd) vs Rd alone.

  • Patients studied had received at least one prior medicine to treat their multiple myeloma

569 patients

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DARZALEX® + Revlimid® + dexamethasone (DRd)
286 patients

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Rd alone
283 patients

At a median follow-up of 13.5 months

82% with DARZALEX® + Rd

82% of patients treated with the IV formulation of DARZALEX® + Revlimid® (R) + dexamethasone (DRd) lived without their disease getting worse vs 59% of patients treated with Rd alone.

91% of patients with DARZALEX® + Rd

About 9 of 10 patients responded to the IV formulation of DARZALEX® + Rd vs about 7 of 10 patients treated with Rd alone.

  • 42.3% of patients had a complete response* or better with DARZALEX® + Rd vs 18.8% with Rd alone

*This means the doctor observed no signs or symptoms of the disease as seen through imaging or other specific blood and bone marrow tests after treatment.

The IV formulation of DARZALEX® (daratumumab) was studied in 498 patients in combination with Velcade® (bortezomib) + dexamethasone (Vd) vs Vd alone.

  • Patient studied had at least one prior medicine to treat their multiple myeloma

498 patients

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DARZALEX® + Velcade® + dexamethasone (DVd)
251 patients

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Vd alone
247 patients

At a median follow-up of 7.4 months

73% with DARZALEX® + Vd

73% of patients treated with the IV formulation of DARZALEX® + Velcade® (V) + dexamethasone (DVd) lived without their disease getting worse vs 51% of patients treated with Vd alone.

79% of patients with DARZALEX® + Vd

About 8 of 10 patients responded to the IV formulation of DARZALEX® + Vd vs 6 of 10 patients treated with Vd alone.

  • 18.3% of patients had a complete response* or better with DARZALEX® + Vd vs 8.5% with Vd alone

*This means the doctor observed no signs or symptoms of the disease as seen through imaging or other specific blood and bone marrow tests after treatment.