Drug Trials Snapshots: DECNUPAZ
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The "MORE INFO" bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the DECNUPAZ Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
DECNUPAZ (pivekimab sunirine)
(DEK-nuh-paz)
AbbVie Inc.
Approval date: May 27, 2026
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
DECNUPAZ is a prescription medicine used to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and fast-growing cancer of the bone marrow and blood that can affect multiple organs, including the skin, lymph nodes, spleen, and liver.
How is this drug used?
DECNUPAZ is given in to your vein (intravenous infusion) once every three weeks. The dose is based on a patient’s body weight.
Who participated in the clinical trials?
The FDA approved DECNUPAZ based on evidence from one clinical trial (CADENZA, NCT03386513) of 116 adult patients with CD123-positive blood or bone marrow cancers, of whom 84 patients had BPDCN. There were 33 patients who had BPDCN that was never treated before, and 51 patients had BPDCN that either came back after previous treatment or did not get better with other treatment(s). The trial occurred at 18 locations in four countries: the United States, Italy, Spain, and France. The study included 73 patients in the United States.
How were the trials designed?
The benefits and side effects of DECNUPAZ were evaluated in one open-label trial in adult patients with CD123-positive blood or bone marrow cancers. The efficacy of DECNUPAZ was evaluated in 84 patients with BPDCN who received DECNUPAZ intravenously (through a vein) once every three weeks until the disease worsened or patients experienced unacceptable side effects. The safety of DECNUPAZ was evaluated in a pooled population of 116 patients who received the approved dose of DECNUPAZ. This pooled safety population included the 84 patients with BPDCN as well as additional enrolled patients with other CD123-positive blood or bone marrow cancers treated at the approved dose.
The benefit of DECNUPAZ was evaluated by measuring the percentage of patients whose blood cancer disappeared completely (complete remission [CR]) or almost completely with only residual skin changes (clinical complete remission [CRc]) after treatment.
How were the trials designed?
The efficacy and safety of DECNUPAZ were evaluated in 116 adult patients with CD123-positive hematologic malignancies enrolled on CADENZA, a multicenter, open-label, single-arm clinical trial. Patients were required to have no evidence of central nervous system (CNS) disease prior to enrollment. Patients received DECNUPAZ at 0.045 mg/kg intravenously once every three weeks until disease progression or unacceptable toxicity.
The efficacy population consisted of 84 adult patients, including 33 patients with treatment-naïve BPDCN and 51 patients with relapsed or refractory BPDCN. Efficacy was established based on the rate of CR/CRc and duration of CR/CRc.
The safety population consisted of 116 adult patients with newly diagnosed treatment-naïve or relapsed/refractory myeloid malignancies, treated with DECNUPAZ at 0.045 mg/kg intravenously once every three weeks until disease progression or unacceptable toxicity.
DEMOGRAPHICS SNAPSHOT
Figure 1 and Figure 2 summarize how many male and female patients were enrolled in the clinical trial used to evaluate the efficacy of DECNUPAZ.
Figure 1. Baseline Demographics by Sex, Efficacy Population, Treatment-Naive BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm
Figure 2. Baseline Demographics by Sex, Efficacy Population, R/R BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; R/R, relapsed or refractory
Figure 3 and Figure 4 summarize how many patients by race were enrolled in the clinical trial used to evaluate the efficacy of DECNUPAZ.
Figure 3. Baseline Demographics by Race, Efficacy Population, Treatment-Naive BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm
Figure 4. Baseline Demographics by Race, Efficacy Population, R/R BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; R/R, relapsed or refractory
Figure 5 and Figure 6 summarize how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of DECNUPAZ.
Figure 5. Baseline Demographics by Age, Efficacy Population, Treatment-Naive BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm
Figure 6. Baseline Demographics by Age, Efficacy Population, R/R BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; R/R, relapsed or refractory
Figure 7 and Figure 8 summarize how many patients by ethnicity were enrolled in the clinical trial used to evaluate the efficacy of DECNUPAZ.
Figure 7. Baseline Demographics by Ethnicity, Efficacy Population, Treatment-Naive BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm
Figure 8. Baseline Demographics by Ethnicity, Efficacy Population, R/R BPDCN
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; R/R, relapsed or refractory
Who participated in the trials?
Table 1. Baseline Demographics, Efficacy Population
| Demographic | Treatment-Naive BPDCN N=33 n (%) | R/R BPDCN N=51 n (%) |
|---|---|---|
| Sex | ||
| Female | 6 (18) | 9 (18) |
| Male | 27 (82) | 42 (82) |
| Age, years | ||
| 18 to <65 | 3 (9) | 21 (41) |
| 65 to <75 | 17 (52) | 16 (31) |
| ≥75 | 13 (39) | 14 (27) |
| Race | ||
| White | 27 (82) | 42 (82) |
| Black or African American | 1 (3) | 2 (4) |
| Asian | 0 | 1 (2) |
| Not reported | 5 (15) | 6 (12) |
| Ethnicity | ||
| Hispanic or Latino | 4 (12) | 8 (16) |
| Not Hispanic or Latino | 28 (85) | 38 (75) |
| Unknown | 1 (3) | 5 (10) |
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; R/R, relapsed or refractory
What are the benefits of this drug?
The benefit of DECNUPAZ was measured by the percentage of patients with BPDCN whose disease disappeared completely (complete remission [CR]) or almost completely with only residual skin changes (clinical complete remission [CRc]) after treatment. In the trial, of the 33 patients who had BPDCN that were not treated before, 23 (70%) achieved CR or CRc, which lasted a median of 9.7 months. Of the 51 patients who had BPDCN that came back or did not get better with other treatments, 8 (16%) achieved CR or CRc, which lasted a median of 9.2 months.
What are the benefits of this drug?
Table 2. Efficacy Results in Treatment-Naive and R/R BPDCN Groups
| Parameter | Treatment-Naive BPDCN N=33 | R/R BPDCN N=51 |
|---|---|---|
| CR/CRc rate, n (%) | 23 (69.7) | 8 (15.7) |
| 95% CI | 51.3, 84.4 | 7.0, 28.6 |
| CR, n (%) | 16 (48.5) | 7 (13.7) |
| 95% CI | 30.8, 66.5 | 5.7, 26.3 |
| CRc, n(%) | 7 (21.2) | 1 (2.0) |
| 95% CI | 9.0, 38.9 | 0.1, 10.5 |
| Duration of CR/CRc, months | ||
| Median | 9.7 | 9.2 |
| 95% CI | 2.9, not estimable | NA |
| Range | NA | 2.7, 27.6+ |
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; CI, confidence interval; CR, complete remission; CRc, clinical complete remission; NA, not applicable; R/R, relapsed or refractory
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: Due to the small number of female patients, differences between males and females in how well DECNUPAZ worked could not be determined.
- Race: Most patients were White. Due to the small number of patients in racial groups other than White, differences in how well DECNUPAZ worked among races could not be determined.
- Age: Due to the small number of patients in each age group, differences in how well DECNUPAZ worked among age groups could not be determined.
Were there any differences in how well the drug worked in clinical trials among sex, race, age, and ethnicity subgroups?
Although some numerical differences in how well the drug worked were observed among sex, race, age, and ethnicity subgroups, no meaningful or consistent differences in response rates were identified. Interpretation of these subgroup analyses is limited by the small number of patients in many subgroups.
Table 3. Efficacy Results (CR+CRc Rate) by Subgroup in Treatment-Naive BPDCN and R/R BPDCN Treatment Groups
| Demographic Subgroup | Treatment-Naive BPDCN, N=33 | R/R BPDCN, N=51 | ||
|---|---|---|---|---|
| n/N (%) | 95% CI | n/N (%) | 95% CI | |
| Sex | ||||
| Female | 6/6 (100.0) | 54.07, 100.00 | 1/9 (11.1) | 0.28, 48.25 |
| Male | 17/27 (63.0) | 42.37, 80.60 | 7/42 (16.7) | 6.97, 31.36 |
| Age, years | ||||
| <65 | 1/3 (33.3) | 0.84, 90.57 | 5/21 (23.8) | 8.22, 47.17 |
| 65 to <75 | 13/17 (76.5) | 50.10, 93.19 | 2/16 (12.5) | 1.55, 38.35 |
| ≥75 | 9/13 (69.2) | 38.57, 90.91 | 1/14 (7.1) | 0.18, 33.87 |
| Race | ||||
| White | 19/27 (70.4) | 49.82, 86.25 | 6/42 (14.3) | 5.43, 28.54 |
| Black or African American | 1/1 (100.0) | 2.50, 100.00 | 0/2 | 0.00, 84.19 |
| Asian | 0/0 | NA | 0/1 | 0.00, 97.50 |
| Not reported | 3/5 (60.0) | 14.66, 94.73 | 2/6 (33.3) | 4.33, 77.72 |
| Ethnicity | ||||
| Hispanic or Latino | 2/4 (50.0) | 6.76, 93.24 | 3/8 (37.5) | 8.52, 75.51 |
| Not Hispanic or Latino | 20/28 (71.4) | 51.33, 86.78 | 4/38 (10.5) | 2.94, 24.80 |
| Unknown | 1/1 (100.0) | 2.50, 100.00 | 1/5 (20.0) | 0.51, 71.64 |
Source: Adapted from FDA Review
Abbreviations: BPDCN, blastic plasmacytoid dendritic cell neoplasm; CI, confidence interval; CR, complete remission; CRc, clinical complete remission; NA, not applicable; R/R, relapsed or refractory
What are the possible side effects?
DECNUPAZ may cause a severe form of liver damage (hepatotoxicity) called veno-occlusive disease (blockage of small blood vessels that makes it hard for blood to leave the liver, leading to backup and swelling), including severe or fatal hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome).
DECNUPAZ may cause a serious side effect called infusion-related reaction, which may be life-threatening or lead to death if not treated. DECNUPAZ contains sulfite and may cause severe, life-threatening allergic reactions in some people. DECNUPAZ may cause severe fluid retention and harm to an unborn baby.
The most common side effects of DECNUPAZ include swelling (edema), tiredness (fatigue), muscle and joint pain (musculoskeletal pain), bleeding (hemorrhage), infusion-related reactions, nausea, diarrhea, changes in kidney function tests (increased creatinine), low albumin levels, and changes in liver function tests (transaminases increased).
What are the possible side effects (results of trials used to assess safety)?
The safety of DECNUPAZ was evaluated in 116 adult patients with myeloid malignancies who received DECNUPAZ 0.045 mg/kg once every three weeks in CADENZA.
Table 4. Adverse Reactions (≥10%) in Patients Who Received DECNUPAZ, Safety Population
| Adverse Reaction1 | DECNUPAZ, N=116 | |
|---|---|---|
| All Grades % | Grade 3 or 4 % | |
| General disorders and administration site conditions | ||
| Edemaa | 52 | 16 |
| Fatigueb | 34 | 5 |
| Pyrexiab | 16 | 0.9 |
| Chills | 11 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal painb | 34 | 8 |
| Vascular disorders | ||
| Hemorrhageb | 28 | 6 |
| Thrombosisb | 13 | 5 |
| Injury, poisoning and procedural complications | ||
| Infusion-related reactions | 26 | 5 |
| Fall | 13 | 1.7 |
| Gastrointestinal disorders | ||
| Nauseab | 24 | 0.9 |
| Diarrheab | 21 | 0.9 |
| Constipation | 19 | 0 |
| Abdominal painb | 14 | 0.9 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspneab | 19 | 1.7 |
| Coughb | 15 | 0 |
| Skin and subcutaneous tissue disorders | ||
| Rashc | 19 | 0 |
| Nervous system disorders | ||
| Neuropathy peripherald | 18 | 1.7 |
| Headacheb | 16 | 2.6 |
| Dizzinessb | 10 | 0.9 |
| Metabolism and nutrition disorders | ||
| Decreased appetiteb | 16 | 0.9 |
| Infections and infestations | ||
| Infections without specified pathogensb | 16 | 6 |
| Viral infectionse | 13 | 6 |
| Bacterial infectionsf | 12 | 5 |
| Pneumoniag | 11 | 9 |
| Psychiatric disorders | ||
| Insomnia | 15 | 0 |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia | 11 | 11 |
Source: DECNUPAZ Prescribing Information
1 Adverse reactions were graded based on CTCAE Version 4.03
a Edema includes acute pulmonary edema, face edema, generalized edema, hypervolemia, edema, edema genital, edema peripheral, pericardial effusion, peripheral swelling, pleural effusion, pulmonary edema, swelling face, weight increased, and ascites
b Consists of multiple related terms
c Rash includes erythema, erythema nodosum, guttate psoriasis, photosensitivity reaction, psoriasis, rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic, skin lesion, skin lesion inflammation, and stasis dermatitis
d Neuropathy peripheral includes burning sensation, dysesthesia, facial nerve disorder, hypoesthesia, IIIrd nerve disorder, neuralgia, neuropathy peripheral, paresthesia, and sciatica
e Viral infections includes COVID-19, cytomegalovirus infection, HCoV-229E infection, herpes simplex, herpes zoster, herpes zoster disseminated, influenza, ophthalmic herpes simplex, and oral herpes
f Bacterial infections includes cellulitis, clostridium difficile infection, erysipelas, folliculitis, and vulval abscess
g Pneumonia includes pneumocystis jirovecii pneumonia, pneumonia, and pneumonia viral
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events
Were there any differences in side effects in clinical trials among sex, race, and age?
- Sex: No clear differences in side effects were seen between male and female patients. However, the analysis was limited due to small number of female patients.
- Race: No clear differences in side effects were seen between patients of different race or ethnicity. However, the analysis was limited due to the majority of patients being White.
- Age: No clear differences in side effects were seen between male and female patients. However, the analysis was limited due to small number of patients in each age group.
Were there any differences in side effects of the clinical trials among sex, race, age, and ethnicity subgroups?
Table 5. Differences in Side Effects by Subgroup, Safety Population
| Demographic Subgroup | N | All Grades n (%) | Grade 3 or 4 n (%) |
|---|---|---|---|
| Sex | |||
| Female | 25 | 25 (100) | 17 (68) |
| Male | 91 | 90 (99) | 67 (74) |
| Age, years | |||
| 18 to <65 | 35 | 35 (100) | 25 (71) |
| 65 to <75 | 48 | 48 (100) | 36 (75) |
| ≥75 | 33 | 32 (97) | 23 (70) |
| Race | |||
| White | 98 | 97 (99) | 67 (68) |
| Black or African American | 4 | 4 (100) | 4 (100) |
| Asian | 1 | 1 (100) | 0 |
| Not reported | 13 | 13 (100) | 13 (100) |
| Ethnicity | |||
| Hispanic or Latino | 15 | 15 (100) | 13 (87) |
| Not Hispanic or Latino | 94 | 93 (99) | 64 (68) |
| Unknown | 7 | 7 (100) | 7 (100) |
Source: Adapted from FDA Review
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.