CLINICAL RESULTS
DARZALEX FASPRO® and DARZALEX® were studied in adult patients with newly diagnosed and relapsed or refractory multiple myeloma.
Studies for newly diagnosed multiple myeloma
The main goal of the study was to measure the length of time patients lived without having their multiple myeloma get worse or passing away. Another goal was to measure overall response rate, which is the percentage of patients who responded to treatment. Patients followed the complete dosing schedule for DARZALEX® + lenalidomide + dexamethasone (DRd).
The IV formulation of DARZALEX® was studied in 737 patients in combination with 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
DARZALEX® + lenalidomide (R) + dexamethasone (d)
368 patients
Rd alone
369 patients
At a median follow-up of 28 months
74% (271 out of 368) of patients in the DRd group lived without having their disease get worse or passing away vs 61% (226 out of 369) of patients in the Rd group.
About 9 of 10 patients responded to the IV formulation of DARZALEX® + Rd vs about 8 of 10 patients treated with Rd alone.
- 47.6% 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.
Learn about the side effects experienced during clinical trials
The main goal of the study was to measure the length of time patients lived without having their multiple myeloma get worse or passing away from any cause. Another goal was to measure overall response rate, which is the percentage of patients who responded to treatment.
The IV formulation of DARZALEX® was studied in 706 patients in combination with 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
DARZALEX® + bortezomib (V) + melphalan (M) + prednisone (P)
350 patients
VMP alone
356 patients
At a median follow-up of 16.5 months
75% (262 out of 350) of patients in the DVMP group lived without having their disease get worse or passing away vs 60% (213 out of 356) of patients in the VMP group.
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.
Learn about the side effects experienced during clinical trials
The IV formulation of DARZALEX® was studied in 1,085 patients in combination with bortezomib + thalidomide + dexamethasone (VTd) vs VTd alone.
- Patients studied were newly diagnosed with multiple myeloma and were eligible to receive a type of stem cell transplant that used their own stem cells
- In this study, patients received initial (induction) therapy with either DARZALEX® + VTd or VTd alone
- After induction, patients received high-dose chemotherapy and a type of stem cell transplant that used their own stem cells
- 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
The main goal of the study was to measure stringent complete response, also known as sCR, which is a robust measure reflecting deep responses. Another goal of the study was to measure the length of time patients lived without their multiple myeloma getting worse.
Clinical study results
More patients achieved sCR with DARZALEX® in combination with VTd compared with patients treated with VTd alone.
29% of patients treated with DARZALEX® + VTd (n=543) achieved sCR vs 20% of patients treated with VTd (n=542) alone.
The overall response rate (which includes all levels of response) was 93% of patients treated with DARZALEX® + VTd vs 90% of patients treated with VTd alone.
1,085 patients
DARZALEX® + bortezomib (V) + thalidomide (T) + dexamethasone (d)
543 patients
VTd alone
542 patients
At a median follow-up of 18.8 months
91.7% (498 out of 543) of patients in the DVTd group lived without having their disease get worse or passing away vs 83.2% (451 out of 542) of patients in the VTd group.
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.
Learn about the side effects experienced during clinical trials
A study confirmed the effectiveness of DARZALEX FASPRO® when used in combination with bortezomib + melphalan + prednisone (VMP) in patients with newly diagnosed multiple myeloma who could not receive a type of stem cell transplant that uses their own stem cells.
The main goal of the study was to measure overall response rate, which is the percentage of patients who responded to treatment.
67 patients
With newly diagnosed multiple myeloma unable to have a transplant using their own stem cells
DARZALEX FASPRO® + bortezomib (V) + melphalan (M) + prednisone (P)
67 patients
At a median follow-up of 6.9 months
88% (about 9 of 10) of patients responded to treatment with DARZALEX FASPRO® in combination with bortezomib, melphalan, and prednisone (DVMP).
Learn about the side effects experienced during clinical trials
Studies for relapsed or refractory multiple myeloma
The main goal of the study was to measure the length of time patients lived without having their multiple myeloma get worse or passing away. Another goal was to measure overall response rate, which is the percentage of patients who responded to treatment.
The IV formulation of DARZALEX® was studied in 569 patients in combination with lenalidomide + dexamethasone (Rd) vs Rd alone.
- Patients studied had received at least one prior medicine to treat their multiple myeloma
569 patients
DARZALEX® + lenalidomide (R) + dexamethasone (d)
286 patients
Rd alone
283 patients
At a median follow-up of 13.5 months
82% (233 out of 286) of patients in the DRd group lived without having their disease get worse or passing away vs 59% (167 out of 283) of patients in the Rd group.
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.
Learn about the side effects experienced during clinical trials
The main goal of the study was to measure the length of time patients lived without having their multiple myeloma get worse or passing away. Another goal was to measure overall response rate, which is the percentage of patients who responded to treatment.
The IV formulation of DARZALEX® was studied in 498 patients in combination with bortezomib + dexamethasone (Vd) vs Vd alone.
- Patient studied had at least one prior medicine to treat their multiple myeloma
498 patients
DARZALEX® + bortezomib (V) + dexamethasone (d)
251 patients
Vd alone
247 patients
At a median follow-up of 7.4 months
73% (184 out of 251) of patients in the DVd group lived without having their disease get worse or passing away vs 51% (125 out of 247) of patients in the Vd group.
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.
Learn about the side effects experienced during clinical trials
DARZALEX® was studied in combination with pomalidomide + dexamethasone (Pd) in 103 patients who had received a prior proteasome inhibitor (PI) and an immunomodulatory agent. These patients had received a median of 4 prior lines of therapy for their multiple myeloma.
The main goal of the study was to measure overall response rate, which is the percentage of patients who responded to treatment.
Clinical study results
When these patients were treated with DARZALEX® in combination with Pd, 59% responded
- This response lasted for a median duration of 13.6 months (range: 0.9+ to 14.6+ months)
13.6 months median duration of response
Of patients who responded, response was seen between 0.9 and 2.8 months.
1 month: Median time it took patients to respond to DARZALEX®
Learn about the side effects experienced during clinical trials
DARZALEX® was studied as monotherapy (by itself) in 106 patients who had either received at least 3 prior medicines to treat their multiple myeloma, including a proteasome inhibitor (PI) and an immunomodulatory agent, or did not respond to a PI and an immunomodulatory agent. These patients had received a median of 5 prior lines of therapy for their multiple myeloma.
The main goal of the study was to measure overall response rate, which is the percentage of patients who responded to treatment.
Clinical study results
When these patients were treated with DARZALEX®, 29% responded
- This response lasted for a median duration of 7.4 months (range: 1.2 to 13.1+ months)
Of patients who responded, response was seen between 0.9 and 5.6 months.
1 month: Median time it took patients to respond to DARZALEX®
Learn about the side effects experienced during clinical trials
A study confirmed the effectiveness of DARZALEX FASPRO® when used in combination with lenalidomide + dexamethasone (Rd) for relapsed or refractory multiple myeloma.
The main goal of the study was to measure overall response rate, which is the percentage of patients who responded to treatment.
65 patients
Who received at least 1 prior medicine
DARZALEX FASPRO® + lenalidomide (R) + dexamethasone (d)
65 patients
91% (about 9 of 10) of patients responded to treatment with DARZALEX FASPRO® in combination with lenalidomide and dexamethasone (DRd).
Learn about the side effects experienced during clinical trials
A study confirmed the effectiveness of DARZALEX FASPRO® when used in combination with pomalidomide + dexamethasone (Pd) for relapsed or refractory multiple myeloma.
The main goal of the study was to measure the length of time patients lived without having their multiple myeloma get worse or passing away.
304 patients
Who received at least 1 prior medicine and were previously treated with lenalidomide (R) and a PI
DARZALEX FASPRO® + pomalidomide (P) + dexamethasone (d)
151 patients
Who received at least 1 prior medicine and were previously treated with lenalidomide (R) and a PI
Pd alone
153 patients
PI=proteasome inhibitor.
At a follow-up of 18 months
44.3% (67 out of 151) of patients in the DPd group lived without having their disease get worse or passing away vs 30.7% (47 out of 153) of patients in the Pd group.
Learn about the side effects experienced during clinical trials
DARZALEX FASPRO® and DARZALEX® comparison study
In order to understand how DARZALEX FASPRO® compared to the intravenous (IV) formulation of DARZALEX®, DARZALEX FASPRO® was evaluated as monotherapy (alone).
A study confirmed that DARZALEX FASPRO® gave patients results comparable to the IV formulation of DARZALEX® in treating multiple myeloma when used by itself.
This study compared treatments in patients with multiple myeloma who had received at least 3 prior medicines or who did not respond to a proteasome inhibitor (PI) and an immunomodulatory agent.
The main goal of the study was to measure overall response rate, which is the percentage of patients who responded to treatment.
522 patients
DARZALEX FASPRO® (monotherapy)
263 patients
DARZALEX® (monotherapy)
259 patients
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