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(daratumumab and hyaluronidase-fihj)

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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

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DARZALEX FASPRO - APOLLO (MMY3013) Study

Last Updated: 11/17/2025

SUMMARY

  • APOLLO is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of daratumumab + pomalidomide + dexamethasone (D-Pd) vs pomalidomide + dexamethasone (Pd) in patients with relapsed or refractory multiple myeloma (RRMM) who received ≥1 prior line of treatment (LOT) with both lenalidomide and a proteasome inhibitor (PI).1-3
    • Dimopoulos et al (2021)3 reported the primary analysis of this ongoing study with a median follow-up of 16.9 months. The D-Pd arm reached a median progression-free survival (PFS) of 12.4 months (95% confidence interval [CI], 8.3-19.3) vs Pd arm achieving a median PFS of 6.9 months (95% CI, 5.5-9.3); (hazard ratio [HR], 0.63; 95% CI, 0.47-0.85; P=0.0018). The most common serious treatment-related adverse events (TEAEs) were pneumonia (D-Pd, 9%; Pd, 1%), lower respiratory tract infection (D-Pd, 3%; Pd, 1%), and febrile neutropenia (D-Pd, 3%; Pd, 1%).
    • Dimopoulos et al (2023)4 reported the final overall survival (OS) results and updated safety analysis of the APOLLO study at a median follow-up of 39.6 months. Median OS in the intent-to-treat (ITT) population was 34.4 months (95% CI, 23.7-40.3) vs 23.7 months (95% CI, 19.629.4) in the D-Pd vs Pd arm, respectively (HR, 0.82; 95% CI, 0.61-1.11; P=0.20). The most common grade 3 TEAEs (>10%) in the D-Pd arm were neutropenia (25%), anemia (17%), and leukopenia (11%), while those in the Pd arm were neutropenia (32%), anemia (21%), and thrombocytopenia (13%). The most common serious TEAE was pneumonia (D-Pd, 15%; Pd, 9%).

CLINICAL DATA

APOLLO (MMY3013; NCT03180736) is an ongoing phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of D-Pd vs Pd in patients with RRMM who received ≥1 prior treatment with both lenalidomide and a PI (N=304).1-3 Dimopoulos et al (2021)3 reported the primary analysis of this ongoing study with a median follow-up of 16.9 months. Sonneveld et al (2021)5 presented updated efficacy and safety results at a median follow-up of 30.7 months. Dimopoulos et al (2023)4 reported the final OS and updated safety analysis of D-Pd vs Pd alone in patients with RRMM in the APOLLO study with a median follow-up of 39.6 months.

Study Design/Methods

APOLLO (MMY3013): Study Design1-4,6

Abbreviations: CR, complete response; CrCl, creatinine clearance; d, dexamethasone; D, daratumumab; D-Pd, daratumumab + pomalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; HRQoL, health-related quality of life; Ig, immunoglobulin; IgA, immunoglobulin A; IgD, immunoglobulin D, IgE, immunoglobulin E, IgG, immunoglobulin G, IgM, immunoglobulin M; ISS, International Staging System; MM, multiple myeloma; MRD, minimal residual disease; ORR, overall response rate; OS, overall survival; P, pomalidomide; Pd, pomalidomide + dexamethasone; PD, progressive disease; PFS, progression-free survival; PI, proteasome inhibitor; PO, oral; QW, every week; Q2W, every 2 weeks; Q4W, every 4 weeks; RRMM, relapsed/refractory multiple myeloma; sCR, stringent complete response; VGPR, very good partial response.
aMeasurable disease was defined as: IgG MM, serum M-protein level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; IgA, IgD, IgE, IgM MM, serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; light chain MM for patients without measurable disease in the serum or urine, serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio.
bPre-infusion medications to be administered are acetaminophen, dexamethasone, diphenhydramine, and a leukotriene inhibitor (optional). Patients with a higher risk of respiratory complications will receive post-infusion medications, including diphenhydramine, a short-acting β2 adrenergic receptor agonist, and lung disease control medications.
cPatients initially were given DARZALEX 16 mg/kg; following a protocol amendment, new patients in the D-Pd arm received DARZALEX FASPRO. Patients who had already received DARZALEX prior to this amendment may switch to DARZALEX FASPRO on day 1 of cycle 3+.
dPatients aged ≥75 years received 20 mg QW.
eFollow-up is for patients who discontinued treatment for reasons other than PD, death, loss to follow-up, or withdrawal of consent.
fMRD was assessed by next-generation sequencing using bone marrow aspirate samples obtained at screening; at the time of suspected CR or sCR; and at 6, 12, 18, 24, and Q12W after achieving CR or sCR until disease progression.
gDisease assessments were collected by a central laboratory every cycle for the first 14 months and every other month thereafter.

Primary Analysis of the APOLLO Study

Results

Dimopoulos et al (2021)3 reported the primary analysis of this ongoing study with a median follow-up of 16.9 months.

Patient Characteristics
  • Baseline characteristics are summarized in Table: Demographics and Baseline Characteristics.
  • A total of 98% of patients in the D-Pd arm received DARZALEX FASPRO.
  • A total of 95% (n/N=142/149) of patients in the D-Pd arm started treatment with DARZALEX FASPRO.
  • Seven of 149 patients started treatment with DARZALEX. Among these patients, 4 switched to DARZALEX FASPRO and 3 progressed on DARZALEX before switching was permitted per the protocol amendment.
  • Median duration of study treatment was 11.5 months in the D-Pd arm vs 6.6 months in the Pd arm.
  • The most common reason for treatment discontinuation was progressive disease, as presented in Table: Treatment Disposition.

Demographics and Baseline Characteristicsa, 3
D-Pd (n=151)
Pd (n=153)
Age, years
   Median (range)
67 (42-86)
68 (35-90)
   Distribution, n (%)
      <65
63 (42)
60 (39)
      65 to <75
63 (42)
62 (41)
      ≥75
25 (17)
31 (20)
Race, n (%)
   White
135 (89)
137 (90)
   Non-white
16 (11)
16 (10)
Gender, n (%)
   Male
79 (52)
82 (54)
   Female
72 (48)
71 (46)
ECOG PS score,b n (%)
   0
91 (60)
77 (50)
   1
54 (36)
57 (37)
   2
6 (4)
19 (12)
ISS disease stage,c n (%)
   I
68 (45)
69 (45)
   II
50 (33)
51 (33)
   III
33 (22)
33 (22)
Type of MM,d n (%)
   IgG
62 (41)
63 (41)
   IgA
24 (16)
20 (13)
   Othere
1 (1)
0
   Detected in urine only
17 (11)
17 (11)
   Detected as serum free light-chain only
24 (16)
25 (16)
   Serum and urine
23 (15)
28 (18)
Cytogenetic profilef
   N
103
108
   Standard risk, n (%)
64 (62)
73 (68)
   High risk, n (%)
39 (38)
35 (32)
Time since MM diagnosis, years
   Median (range)
4.4 (0.5-20.0)
4.5 (0.6-19.0)
Creatinine clearance
   ≤60 mL/min
40 (26)
47 (31)
   >60 mL/min
111 (74)
106 (69)
Hepatic function
   Normal
136 (90)
127 (83)
   Impaired
15 (10)
26 (17)
Prior LOT
   Median (range)
2 (1-5)
2 (1-5)
   Distribution, n (%)
      1
16 (11)
18 (12)
      2-3
114 (75)
113 (74)
      ≥4
21 (14)
22 (14)
Prior PI or IMiD
151 (100)
153 (100)
Prior ASCT, n (%)
90 (60)
81 (53)
Disease refractory to last LOT, n (%)
122 (81)
123 (80)
Disease refractory to, n (%)
   IMiD
119 (79)
122 (80)
   Lenalidomide
120 (79)
122 (80)
   PI
71 (47)
75 (49)
   PI + lenalidomide
64 (42)
65 (42)
   Lenalidomide as last prior LOT
94 (62)
90 (59)
Abbreviations: ASCT, autologous stem cell transplant D-Pd, daratumumab + pomalidomide + dexamethasone; ECOG PS, Eastern Cooperative Oncology Group performance status; IgA, immunoglobulin A; IgG, immunoglobulin G; IMiD, immunomodulatory drug; ISS, International Staging System; LOT, line of therapy; MM, multiple myeloma; Pd, pomalidomide + dexamethasone; PI, proteasome inhibitor. aIntent-to-treat population (N=304). bECOG PS is scored on a scale from 0-5, with 0 indicating no symptoms and higher scores indicating increasing disability. cBased on the combination of serum β2-microglobulin and albumin at study entry. dDetermined by immunofixation. eIncludes IgD, IgE, IgM, and biclonal. fBased on fluorescence in situ hybridization; high risk was defined as del17p, t(4;14), or t(4;16).

Treatment Disposition3
D-Pd (n=151)
Pd (n=153)
Patients treated, n
149
150
Ongoing at clinical cutoff, n
60
33
Discontinued, n
89
117
   Progressive disease
66
87
   Death
10
7
   Adverse event
3
4
   Physician decision
4
7
   Lost to follow-up
1
0
   Noncompliance with study drug
5
12
Abbreviations: D-Pd, daratumumab + pomalidomide + dexamethasone; Pd, pomalidomide + dexamethasone.
Efficacy
  • After a median follow-up of 16.9 months, median PFS was 12.4 months with D-Pd vs 6.9 months with Pd (HR, 0.63; 95% CI, 0.47-0.85; P=0.0018).
    • Median PFS among patients refractory to lenalidomide was 9.9 months with D-Pd vs 6.5 months with Pd.
  • The estimated 12-month PFS rate was 52% with D-Pd vs 35% with Pd.
  • A PFS benefit of D-Pd vs Pd was generally observed in all prespecified subgroups (Table: PFS in Prespecified Subgroups).
  • Overall response rate (ORR; ITT population): 69% D-Pd vs 46% Pd (odds ratio [OR], 2.7; 95% CI, 1.7-4.4; P<0.0001). A summary of response rates and minimal residual disease (MRD) status is shown in table: Summary of Response Rates and MRD Status in the Intent-to-Treat Population.
  • Median time to first response was 1 month (95% CI, 1.0-1.1) in the D-Pd arm and 1.9 months (1.0-2.0) in the Pd arm.
  • Median duration of response was not reached (NR) (95% CI, 15.2-NR) in the D-Pd arm and 5.9 months (8.3-24.8) in the Pd arm.
  • Median time to subsequent therapy was 23.2 months (95% CI, 13.8-not evaluable [NE]) vs 11.8 months (8.9-15.4).
  • The OS data at the time of this analysis was immature; 32% (n=48) of patients died in the D-Pd arm and 33% (n=51) in the Pd arm.

Summary of Response Rates and MRD Status in the Intent-to-Treat Population3
n (%)
D-Pd (N=151)
Pd (N=153)
Odds ratio (95% CI)
P value
Overall response
104 (69; 95% CI 61-76)
71 (46; 95% CI 38-55)
2.7 (1.7-4.4)
<0.0001a
Best overall response
   ≥CR
37 (25)
6 (4)
8.2 (3.4-20.3)
<0.0001a
   sCRb
14 (9)
2 (1)
-
-
   Complete response
23 (15)
4 (3)
-
-
   ≥VGPR
77 (51)
30 (20)
4.3 (2.6-7.3)
<0.0001a
   PR
27 (18)
41 (27)
-
-
   Minimal response
11 (7)
15 (10)
-
-
   Stable disease
26 (17)
49 (32)
-
-
   Progressive disease
4 (3)
7 (5)
-
-
   Response could not be evaluated
6 (4)
11 (7)
-
-
Negative status for MRDd
13 (9)
3 (2)
4.7 (1.3-16.9)
0.010e
Abbreviations: CI, confidence interval; ≥CR, complete response or better; D-Pd, daratumumab + pomalidomide + dexamethasone; IMWG, International Myeloma Working Group; MRD, minimal residual disease; ORR, overall response rate; Pd, pomalidomide + dexamethasone; PR, partial response; sCR, stringent complete response; ≥VGPR, very good partial response or better. Note: The following secondary endpoints were sequentially tested, each with a two-sided α value of 0.05, by using a hierarchical testing approach: ORR, ≥VGPR rate, ≥CR rate, rate of MRD negative. ap value was calculated using the Cochran-Mantel-Haenszel χ² test. bCriteria for a sCR include the criteria for a complete response plus a normal free light-chain ratio and absence of clonal plasma cells, as assessed by immunofluorescence or immunohistochemical analysis. dNegative status for MRD, using a sensitivity threshold of one tumor cell per 10⁵ white cells, is based on a post-randomization assessment of bone marrow samples using a validated next-generation sequencing assay (clonoSEQ Assay, version 2.0; Adaptive Biotechnologies) in accordance with the MRD assessment guidelines established by the IMWG.ep value (two-sided) was calculated using the Fisher’s exact test.

PFS in Prespecified Subgroups3
Events/patients
Median (95% CI) PFS, months
HR (95% CI)
D-Pd
Pd
D-Pd
Pd
Overall
84/151
106/153
12.4 (8.3-19.3)
6.9 (5.5-9.3)
0.63 (0.47-0.85)
Sex
   Male
46/79
54/82
10.7 (7.4-19.3)
7.2 (4.9-10.6)
0.69 (0.47-1.03)
   Female
38/72
52/71
15.0 (8.2-NE)
6.5 (4.7-9.3)
0.54 (0.35-0.82)
Age
   <65 years
36/63
41/60
9.2 (4.6-21.0)
5.8 (3.7-12.6)
0.69 (0.44-1.09)
   ≥65 years
48/88
65/93
14.2 (9.9-NE)
7.0 (6.1-10.1)
0.55 (0.38-0.81)
Race
   White
75/135
93/137
12.1 (8.2-17.2)
7.4 (5.8-9.6)
0.66 (0.48-0.89)
   Non-white
9/16
13/16
16.2 (4.9-NE)
5.0 (2.6-6.5)
0.34 (0.14-0.82)
ISS disease staging
   1
31/68
43/69
19.3 (9.9-NE)
9.5 (6.5-15.9)
0.62 (0.39-0.98)
   2
32/50
36/51
12.3 (7.5-17.2)
6.1 (2.8-8.9)
0.54 (0.33-0.87)
   3
21/33
27/33
6.1 (3.0-12.9)
5.0 (2.9-9.6)
0.75 (0.42-1.32)
Revised ISS disease staging
   1
11/26
17/25
NE (9.9-NE)
10.4 (4.7-19.6)
0.51 (0.24-1.10)
   2
45/74
64/88
12.3 (7.5-17.2)
6.5 (4.0-8.3)
0.58 (0.39-0.85)
   3
15/19
11/14
2.8 (1.1-4.9)
3.4 (1.9-9.6)
1.38 (0.62-3.11)
Number of prior LOT
   1
9/16
12/18
14.1 (6.5-NE)
12.6 (3.7-19.6)
0.70 (0.30-1.67)
   2-3
65/114
79/113
10.7 (7.5-16.2)
6.5 (4.7-9.5)
0.66 (0.48-0.92)
   ≥4
10/21
15/22
19.3 (6.7-NE)
6.6 (2.9-10.2)
0.40 (0.18-0.90)
Baseline creatinine clearance
   ≤60 ml/min
23/40
36/47
12.1 (5.8-16.2)
6.1 (3.4-9.3)
0.59 (0.35-0.99)
   >60 ml/min
61/111
70/106
12.7 (8.2-NE)
7.8 (5.8-10.2)
0.64 (0.45-0.90)
Type of multiple myeloma
   IgG
43/76
52/79
11.4 (7.8-NE)
8.5 (4.7-11.2)
0.67 (0.45-1.01)
   Non-IgG
20/34
25/32
13.1 (6.5-21.0)
6.9 (3.7-9.6)
0.44 (0.24-0.81)
Cytogenetic profile
   High risk
28/39
26/35
5.8 (4.4-7.5)
4.0 (2.8-9.2)
0.85 (0.49-1.44)
   Standard risk
30/64
50/73
21.0 (12.3-NE)
7.4 (6.0-13.1)
0.51 (0.32-0.81)
Baseline hepatic function
   Normal
69/136
88/127
15.2 (10.3-NE)
6.9 (5.5-9.3)
0.56 (0.41-0.77)
   Impaired
15/15
18/26
6.1 (2.8-8.4)
8.3 (3.4-13.9)
1.72 (0.84-3.50)
ECOG PS
   0
49/91
53/77
12.7 (8.2-NE)
6.9 (4.7-9.3)
0.61 (0.41-0.90)
   ≥1
35/60
53/76
12.1 (6.5-15.2)
7.2 (4.7-10.1)
0.65 (0.42-1.00)
Refractory to lenalidomide
   No
8/31
17/31
NE (NE-NE)
10.6 (5.8-NE)
0.36 (0.15-0.83)
   Yes
76/120
89/122
9.9 (6.5-13.1)
6.5 (4.7-8.9)
0.66 (0.49-0.90)
Refractory to last LOT
   No
9/29
16/20
NE (15.2-NE)
10.6 (5.5-NE)
0.45 (0.20-1.02)
   Yes
72/122
90/123
10.3 (7.4-14.2)
6.5 (4.7-8.9)
0.64 (0.47-0.87)
Refractory to PI
   No
38/80
52/78
21.0 (10.7-NE)
9.3 (5.5-12.6)
0.53 (0.35-0.80)
   Yes
46/71
54/75
8.3 (4.9-12.9)
6.3 (3.8-7.8)
0.73 (0.49-1.08)
Refractory to PI and IMiDs
   No
40/87
58/88
21.0 (10.7-NE)
9.3 (6.0-12.6)
0.52 (0.34-0.77)
   Yes
44/64
48/65
7.7 (3.9-12.3)
7.7 (3.9-12.3)
0.74 (0.49-1.12)
Refractory to lenalidomide as last LOT
   No
25/57
39/63
21.0 (12.9-NE)
7.8 (5.8-15.9)
0.52 (0.31-0.86)
   Yes
59/94
67/90
8.3 (6.5-12.3)
6.1 (4.0-9.3)
0.67 (0.47-0.95)
Abbreviations: D-Pd, daratumumab + pomalidomide + dexamethasone; Pd, pomalidomide + dexamethasone; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; IgG, immunoglobulin G; IMiD, immunomodulatory drug; ISS, International Staging System; LOT, line of therapy; PI, proteasome inhibitor; Pd, pomalidomide + dexamethasone; PFS, progression-free survival.
Safety
  • Infusion-related reactions (IRRs) were reported in 5% of D-Pd patients; all were grade 1 or 2.
  • Local injection-site reactions were reported in 2% of patients who received DARZALEX FASPRO; all were grade 1.
  • The most common serious adverse events (SAEs) were pneumonia (D-Pd, 15%; Pd, 8%) and lower respiratory tract infection (D-Pd, 12%; Pd, 9%).
  • TEAEs leading to treatment discontinuation and TEAEs leading to death were similar in both groups (D-Pd, 2% and 7%; Pd, 3% and 7%, respectively).
  • Incidence of second primary malignancy was 2% in each group.
  • Safety data from the primary analysis are presented in Table: Most Common Adverse Events (Safety Population).

Most Common Adverse Events (Safety Population)a, 3
Adverse Event, n (%)
D-Pd (n=149)
Pd (n=150)
Grade 1/2
Grade 3
Grade 4
Grade 1/2
Grade 3
Grade 4
Hematologic adverse events
   Neutropenia
4 (3)
37 (25)
64 (43)
4 (3)
49 (33)
27 (18)
   Anemia
30 (20)
24 (16)
1 (1)
34 (23)
31 (21)
1 (1)
   Thrombocytopenia
22 (15)
13 (9)
13 (9)
23 (15)
19 (13)
8 (5)
   Leukopenia
14 (9)
16 (11)
9 (6)
11 (7)
6 (4)
1 (1)
   Lymphopenia
4 (3)
10 (7)
8 (5)
7 (5)
3 (2)
2 (1)
   Febrile neutropenia
0
10 (7)
3 (2)
0
3 (2)
1 (1)
Non-hematologic adverse events
   Infections
61 (41)
32 (21)
4 (3)
48 (32)
29 (19)
1 (1)
   Upper respiratory tract infection
34 (23)
0
0
21 (14)
3 (2)
0
   Pneumonia
10 (7)
14 (9)
3 (2)
8 (5)
8 (5)
1 (1)
   Lower respiratory tract infection
12 (8)
14 (9)
2 (1)
10 (7)
11 (7)
2 (1)
   Fatigue
26 (17)
12 (8)
0
31 (21)
7 (5)
0
   Asthenia
25(17)
7 (5)
1 (1)
23 (15)
1 (1)
0
   Diarrhea
25(17)
8 (5)
0
20 (13)
1 (1)
0
   Pyrexia
29 (20)
0
0
21 (14)
0
0
   Hyperglycemia
7 (5)
7 (5)
1 (1)
12 (8)
7 (5)
0
Secondary primary malignancy
3 (2)
NA
NA
3 (2)
NA
NA
Any infusion-related reaction
8 (5%)
0
0
NA
NA
NA
Abbreviations: D-Pd, daratumumab + pomalidomide + dexamethasone; Pd, pomalidomide + dexamethasone.aAdverse events of any grade that were reported in at least 15% of patients in either treatment arm or grade 3/4 adverse events that were reported in at least 5% of patients in either treatment arm are listed.

Updated Analysis of the APOLLO Study

Dimopoulos et al (2023)4 reported the final OS and updated safety analysis of D-Pd vs Pd alone in patients with RRMM in the APOLLO study with a median follow-up of 39.6 months.

Study Design/Methods

  • OS was defined as the number of months from the date of randomization to the date of death (from any cause). Patients were censored at the last date of contact.
  • Patients in the safety population were included if they received ≥1 administration of any study treatment.

Results

Patient Disposition and Treatment Characteristics
  • A total of 304 patients were randomized to receive either D-Pd (n=151) or Pd (n=153) and constituted the ITT population.
  • Patients included in this study were refractory to lenalidomide (D-Pd, 79% [n=120]; Pd, 80% [n=122]), a PI (D-Pd, 47% [n=71]; Pd, 49% [n=75]), or both (DPd, 42% [n=64]; Pd, 42% [n=65]).
  • Median duration of exposure to study treatment was 11.5 (interquartile range [IQR], 4.6-36.1) months vs 6.6 (IQR, 3.2-15.0) months in the D-Pd vs Pd arm, respectively.
  • The median duration of follow-up was 39.6 (IQR, 37.1-43.7) months.
  • In the safety population (D-Pd, n=149; Pd, n=150), the median relative dose intensity of DARZALEX and DARZALEX FASPRO was 86% (IQR, 80-94) and 95% (IQR, 86-100), respectively. In the D-Pd vs Pd arm, the median relative dose intensity of pomalidomide and dexamethasone was 74% (IQR, 55‑94) vs 91% (IQR, 77‑98; P<0.0001) and 78% (IQR, 49-95) vs 87% (IQR, 64-97; P=0.0278), respectively.
Efficacy
  • Median PFS on the next line of therapy (PFS2) was 24.4 months (95% CI, 17.1-35.7) vs 17.6 months (95% CI, 13.622.0) in the D-Pd vs Pd arm, respectively (HR, 0.73; 95% CI, 0.55-0.98; P=0.034).
    • The 3-year PFS2 rate was 41.4% (95% CI, 33.1-49.4) vs 27% (95% CI, 19.834.8) in the D-Pd vs Pd arm, respectively.
  • Median OS was 34.4 months (95% CI, 23.7-40.3) vs 23.7 months (95% CI, 19.6-29.4) in the D-Pd vs Pd arm, respectively (HR, 0.82; 95% CI, 0.61-1.11; P=0.20).
  • Median time to subsequent therapy was 20.0 months (95% CI, 13.8-27.1) vs 11.8 months (95% CI, 8.9-15.4) in the D-Pd vs Pd arm, respectively (HR, 0.61; 95% CI, 0.45-0.82; P=0.0008).
  • In the safety population, a total of 48% (n=72) of patients in the D-Pd arm and 68% (n=102) of patients in the Pd arm received subsequent therapy in any line as presented in Table: Most Common (>10%) subsequent antimyeloma therapies.

Most Common (>10%) Subsequent Antimyeloma Therapiesa,4
Total receiving subsequent therapy, n (%)
Any Subsequent LOT
Next Subsequent LOT
D-Pdb
(n=72)
Pd
(n=102)
D-Pdb
(n=72)
Pd
(n=102)
Dexamethasone
57 (79)
83 (81)
51 (71)
72 (71)
Carfilzomib
31 (43)
34 (33)
24 (33)
24 (24)
Cyclophosphamide
26 (36)
36 (35)
13 (18)
19 (19)
Bortezomib
20 (28)
37 (36)
10 (14)
26 (25)
Pomalidomide
14 (19)
23 (23)
7 (10)
14 (14)
Lenalidomide
11 (15)
19 (19)
10 (14)
11 (11)
Selinexor
11 (15)
2 (2)
5 (7)
0
Thalidomide
8 (11)
3 (3)
4 (6)
1 (1)
DARZALEX
5 (7)
66 (65)
4 (6)
47 (46)
Abbreviations: D-Pd, daratumumab + pomalidomide + dexamethasone; LOT, line of therapy; Pd, pomalidomide + dexamethasone.aSubsequent systemic antimyeloma therapy was reported based on therapeutic class, pharmacological class, and preferred term.bD-Pd arm included all patients who received DARZALEX, regardless of the route of administration, with Pd.Note: Percentages have been rounded and therefore might not add up to 100%.

Safety

  • No new safety concerns were reported with longer follow-up.
  • The most common any grade and grade 3/4 TEAEs are presented in Table: Summary of Most Common TEAEs in the Safety Population.
  • Serious TEAEs were reported in 54% (n=80) vs 40% (n=60) of patients in the D-Pd vs Pd arm, respectively.
    • The most common serious TEAE was pneumonia (D-Pd, 15% [n=23]; Pd, 9% [n=13]).
  • Treatment modification occurred in 87% (n=130) vs 75% (n=112) of patients in the DPd vs Pd arm, respectively.
  • Treatment discontinuation due to TEAEs was low among both treatment arms (D-Pd, 2% [n=3]; Pd, 4% [n=6]).
    • Treatment discontinuation due to infection was reported in 1 (1%) patient each in both arms (D-Pd, meningoencephalitis bacterial infection; Pd, Coronavirus Disease 2019 [COVID-19]).
  • A total of 55% (n=83) vs 59% (n=91) of patients in the D-Pd vs Pd arm, respectively, died primarily due to disease progression, adverse events (AEs) unrelated to the study treatment, or COVID-19.
  • Second primary malignancies (cutaneous, invasive, and hematological) were reported in 3% (n=4) vs 4% (n=6) of patients in the D-Pd vs Pd arm, respectively.
    • In the D-Pd arm, cholangiocarcinoma, malignant melanoma, and squamous cell carcinoma were each reported in 1% (n=1) of patients.
    • In the Pd arm, malignant melanoma, acute myeloid leukemia, metastatic renal cell carcinoma, and thyroid neoplasm were each reported in 1% (n=1) of patients.
  • TEAEs leading to death were reported in 9% (n=13) of patients each in both arms.
    • The most common TEAEs leading to death were pneumonia (D-Pd, 2% [n=3]; Pd, 1% [n=2]) and COVID-19 (D-Pd, 1% [n=2]; Pd, 1% [n=1]).

Summary of Most Common TEAEs in the Safety Populationa, 4
TEAE, n (%)
D-Pd (n=149)
Pd (n=150)
Grade 1/2
Grade 3
Grade 4
Grade 5
Total
Grade 1/2
Grade 3
Grade
4
Grade 5
Total
Any AEs
12 (8)
45 (30)
75 (50)
13 (9)
145 (97)
23 (15)
79 (53)
31 (21)
13 (9)
146 (97)
Hematologic
   Anemia
30 (20)
26 (17)
1 (1)
0
57 (38)
35 (23)
31 (21)
1 (1)
0
67 (45)
   Thrombocytopenia
23 (15)
14 (9)
13 (9)
0
50 (34)
23 (15)
20 (13)
8 (5)
0
51 (34)
   Leukopenia
14 (9)
16 (11)
9 (6)
0
39 (26)
11 (7)
6 (4)
1 (1)
0
18 (12)
   Neutropenia
4 (3)
37 (25)
66 (44)
0
107 (72)
4 (3)
48 (32)
28 (19)
0
80 (53)
   Lymphopenia
3 (2)
11 (7)
8 (5)
0
22 (15)
7 (5)
3 (2)
2 (1)
0
12 (8)
   Bone marrow failure
0
0
0
1 (1)
1 (1)
0
0
0
0
0
   Febrile neutropenia
0
10 (7)
3 (2)
0
13 (9)
0
4 (3)
1 (1)
0
5 (3)
Non-hematologic
   Upper respiratory tract infection
37 (25)
0
0
0
37 (25)
21 (14)
3 (2)
0
0
24 (16)
   Pyrexia
31 (21)
0
0
0
31 (21)
26 (17)
0
0
0
26 (17)
   Diarrhea
28 (19)
8 (5)
0
0
36 (24)
22 (15)
1 (1)
0
0
23 (15)
   Fatigue
28 (19)
15 (10)
0
0
43 (29)
31 (21)
7 (5)
0
0
38 (25)
   Asthenia
25 (17)
7 (5)
1 (1)
0
33 (22)
23 (15)
2 (1)
0
0
25 (17)
   Peripheral edema
25 (17)
0
0
0
25 (17)
14 (9)
0
0
0
14 (9)
   Bronchitis
22 (15)
0
0
0
22 (15)
15 (10)
3 (2)
0
0
18 (12)
   Dyspnea
12 (8)
3 (2)
1 (1)
1 (1)
17 (11)
12 (8)
1 (1)
0
0
13 (9)
   Lower respiratory tract infection
12 (8)
14 (9)
2 (1)
1 (1)
29 (19)
10 (7)
11 (7)
2 (1)
1 (1)
24 (16)
   COVID-19
10 (7)
5 (3)
1 (1)
2 (1)
18 (12)
2 (1)
0
0
1 (1)
3 (2)
   Hyperglycemia
9 (6)
8 (5)
1 (1)
0
18 (12)
13 (9)
7 (5)
0
0
20 (13)
   Muscular weakness
9 (6)
0
1 (1)
0
10 (7)
5 (3)
0
0
0
5 (3)
   Pneumonia
9 (6)
14 (9)
4 (3)
3 (2)
30 (20)
9 (6)
9 (6)
1 (1)
2 (1)
21 (14)
   Hypokalemia
6 (4)
6 (4)
1 (1)
0
13 (9)
8 (5)
1 (1)
0
0
9 (6)
   Hyperuricemia
3 (2)
1 (1)
1 (1)
0
5 (3)
3 (2)
0
1 (1)
0
4 (3)
   Myocardial ischemia
2 (1)
0
0
0
2 (1)
0
0
1 (1)
0
1 (1)
   Acute myocardial infarction
1 (1)
1 (1)
0
0
2 (1)
0
0
0
1 (1)
1 (1)
   General physical health deterioration
1 (1)
1 (1)
0
0
2 (1)
0
2 (1)
0
2 (1)
4 (3)
   Hyperbilirubinemia
1 (1)
0
1 (1)
0
2 (1)
1 (1)
0
0
0
1 (1)
   Lumbar vertebral fracture
1 (1)
0
1 (1)
0
2 (1)
0
2 (1)
0
0
2 (1)
   Acute pulmonary edema
0
0
1 (1)
0
1 (1)
0
0
0
0
0
   Campylobacter infection
0
0
0
1 (1)
1 (1)
0
0
0
0
0
   Cardiac arrest
0
0
0
0
0
0
0
0
1 (1)
1 (1)
   Cerebral hemorrhage
0
0
0
0
0
0
0
0
1 (1)
1 (1)
   Embolism
0
0
1 (1)
0
1 (1)
0
0
0
0
0
   Hypertensive hydrocephalus
0
0
0
0
0
0
0
0
1 (1)
1 (1)
   Liver disorder
0
0
0
1 (1)
1 (1)
0
0
0
0
0
   Pneumonia aspiration
0
0
0
1 (1)
1 (1)
0
0
0
1 (1)
1 (1)
   Respiratory failure
0
1 (1)
0
1 (1)
2 (1)
1 (1)
1 (1)
1 (1)
0
3 (2)
   Sepsis
0
1 (1)
0
1 (1)
2 (1)
0
0
1 (1)
0
1 (1)
   Septic shock
0
0
0
1 (1)
1 (1)
0
0
0
2 (1)
2 (1)
   Sudden death
0
0
0
1 (1)
1 (1)
0
0
0
0
0
   Systemic candida
0
0
0
1 (1)
1 (1)
0
0
0
0
0
   Viral pneumonia
0
0
1 (1)
0
1 (1)
0
0
0
0
0
Abbreviations: AE, adverse event; COVID-19, Coronavirus Disease 2019; D-Pd, daratumumab + pomalidomide + dexamethasone; MedDRA, Medical Dictionary for Regulatory Activities; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; Pd, pomalidomide + dexamethasone; TEAE, treatment-emergent adverse event.aTEAEs are listed for all grade 4 or 5 events and any grade 3 event occurring in ≥15% of patients in either treatment group (corresponding grade 1 or 2 events are listed). Each patient could have >1 event, and multiple occurrences of each event but were only counted once for each row.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 10 November 2025.

 

References

Show
1 Sonneveld P, Terpos E, Dimopoulos M, et al. Pomalidomide and dexamethasone (Pom-Dex) with or without daratumumab (DARA) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): a multicenter, randomized, phase 3 study (APOLLO). Poster presented at: The Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL.  
2 Dimopoulos M, Terpos E, Boccadoro M, et al. APOLLO: phase 3 randomized study of subcutaneous daratumumab plus pomalidomide and dexamethasone (D-Pd) versus pomalidomide and dexamethasone (Pd) alone in patients (pts) with relapsed/refractory multiple myeloma (RRMM). Poster presented at: 62nd American Society of Hematology (ASH) Annual Meeting & Exposition; December 5-8, 2020; Virtual.  
3 Dimopoulos M, Terpos E, Boccadoro M, et al. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812.  
4 Dimopoulos MA, Terpos E, Boccadoro M, et al. Subcutaneous daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (APOLLO): extended follow up of an open-label, randomised, multicentre, phase 3 trial. Lancet Haematol. 2023;10(10):e813-e824.  
5 Sonneveld P, Terpos E, Boccadoro M, et al. Pomalidomide and dexamethasone with or without subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: updated analysis of the phase 3 APOLLO study. Poster presented at: 63rd American Society of Hematology (ASH) Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA/Virtual.  
6 Dimopoulos M, Terpos E, Boccadoro M, et al. Supplement to: Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812.