Decnupaz (pivekimab sunirine-pvzy) / AbbVie - LARVOL DELTA

Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm. (PubMed, J Clin Oncol) - P1/2 | "PVEK, with convenient dosing, led to high, durable responses, especially in frontline BPDCN, and a manageable safety profile."

Clinical • Journal • Fatigue • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • Transplantation • CD123 • IL3RA

Blastic Plasmacytoid Dendritic Cell Neoplasm in the Dual CD123-targeted Therapy Era: A Clinical Decision Review of Treatment Selection, Sequencing, CNS Management, and Transplant Integration. (PubMed, Clin Lymphoma Myeloma Leuk) - "Blastic plasmacytoid dendritic cell neoplasm (BPDCN) has entered a dual CD123-targeted therapy era following the availability of tagraxofusp and the 2026 approval of pivekimab sunirine-pvzy. Early donor search, multidimensional response evaluation, and trial enrollment remain integral. The proposed algorithm is evidence-informed rather than guideline-mandated and highlights where prospective studies are most urgently needed."

Journal • Review • Hepatology • Oncology • Transplantation • CD123 • IL3RA

Hematopoietic cell transplantation for blastic plasmacytoid dendritic cell neoplasm: clinical practice guidelines from the American Society for Transplantation and Cellular Therapy. (PubMed, Transplant Cell Ther) - "Treatment of BPDCN has evolved over the years from conventional chemotherapy to novel targeted therapies including anti-CD123 antibody drug conjugates, namely tagraxofusp and pivekimab sunirine, and the BCL-2 inhibitor, namely venetoclax. Post-HCT intrathecal chemotherapy was also recommended regardless of involvement of the central nervous system. Panelists recognized that other unique clinical scenarios not included in these recommendations might demand individualized treatment approaches."

Clinical guideline • Journal • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation • CD123 • IL3RA

Efficacy and safety of pivekimab sunirine in combination with venetoclax plus azacitidine in unfit patients with newly diagnosed Acute Myeloid Leukemia (ASH 2025) - "Unfit pts with newly diagnosed CD123-postive AML demonstrated high CR rates withPVEK+VEN+AZA. These robust response rates were observed across the select mutational profiles tested.Follow up with duration of response and survival estimates among all pts, by molecular subgroups andMRD negativity status, are being evaluated. Triplet therapy in unfit 1L pts with CD-123–positive AML waswell-tolerated, and no new safety signals were observed."

Clinical • Combination therapy • Acute Myelogenous Leukemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myocardial Infarction • Neutropenia • Respiratory Diseases • Thrombocytopenia • CD123 • IL3RA

Broad Activity for the Pivekimab Sunirine (PVEK, IMGN632), Azacitidine, and Venetoclax Triplet in High-Risk Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) (ASH 2022) - P1b/2 | "With a manageable safety profile in patients with R/R AML, the higher-intensity cohorts of the novel PVEK triplet demonstrated anti-leukemia activity across several difficult-to-treat subsets of patients. Enrollment and follow-up in both relapsed and frontline patients are ongoing (NCT04086264). Additional and updated safety and efficacy data will be presented at ASH."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Transplantation • CD123 • FLT3

Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody-drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study. (PubMed, Lancet Oncol) - P1/2 | "Pivekimab sunirine showed single-agent activity across multiple doses, with a recommended phase 2 dose of 0·045 mg/kg once every 3 weeks. These findings led to a phase 1b/2 study of pivekimab sunirine plus azacitidine and venetoclax in patients with CD123-positive acute myeloid leukaemia."

Journal • P1/2 data • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Neutropenia • Oncology • CD123 • IL3RA

A phase 1b/2 study of pivekimab sunirine (PVEK, IMGN632) in combination with venetoclax/azacitidine or magrolimab for patients with CD123-positive acute myeloid leukemia (AML). (ASCO 2023) - P1b/2 | "The PVEK+Magro doublet (Regimen E) is planned to be open for enrollment mid-2023 at sites in the USA. Clinical trial information: NCT04086264."

Clinical • Combination therapy • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD123

The Efficacy of Pivekimab Sunirine in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm With Baseline Skin Involvement in the CADENZA Study (SOHO 2026) - P1/2 | "Patients with first-line BPDCN treated with PVEK had high and durable response rates, regardless of baseline skin burden. Eligible patients were able to proceed to transplant. BPDCN: blastic plasmacytoid dendritic cell neoplasm; CR: complete response; CRc: clinical complete response; mSWAT: Modified Severity-Weighted Assessment Tool; NR: not reached; ORR: overall response rate; OS: overall survival; PVEK: pivekimab sunirine."

Clinical • Oncology • CD123 • IL3RA

Characterization of Edema Adverse Events in the CADENZA Study of Pivekimab Sunirine in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (SOHO 2026) - P1/2 | "Edema events, which were primarily peripheral edema, are well-defined and manageable with diuretics. Most patients experiencing these AEs continued PVEK treatment."

Adverse events • Clinical • Oncology • CD123 • IL3RA

INTERIM ANALYSIS OF A REGISTRATION ENABLING STUDY OF PIVEKIMAB SUNIRINE (PVEK, IMGN632) A CD123-TARGETING ANTIBODY-DRUG CONJUGATE, IN PATIENTS WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN) (EHA 2023) - P1/2 | "BPDCN currently has 1 approved therapy, tagraxofusp (TAG), with a median age of 68, CR/CRc rate of 57% and mOS of 15.8 mos (n=65; Pemmaraju JCO 2022). PVEK demonstrates compelling activity in frontline and R/R BPDCN pts, including durable responses in the R/R setting for pts who received prior TAG. PVEK safety was manageable with primarily low-grade IRRs and edema and no new safety signals were observed. Enrollment continues in the pivotal de novo frontline BPDCN cohort (NCT03386513) Antibody targeting, Monoclonal antibody, Myeloid malignancies"

Clinical • Chronic Myelomonocytic Leukemia • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Neutropenia • Oncology • Thrombocytopenia • Transplantation • CD123

Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. (ASCO 2025) - P1/2 | "Pts with R/R BPDCN had received 1-3 prior systemic therapies; 57% had prior tagraxofusp. PVEK treatment demonstrated promising efficacy, with high and durable CR + CRc responses. PVEK was tolerable at the RP2D. The safety profile was manageable, with no CLS events."

Clinical • Hematological Malignancies • Hepatology • Oncology • CD123 • IL3RA

EFFICACY AND SAFETY OF PIVEKIMAB SUNIRINE (PVEK) IN PATIENTS (PTS) WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN) IN THE CADENZA STUDY (EHA 2025) - P1/2 | "Pts with R/R BPDCN had received 1-3 prior systemic therapies; 57% had prior tagraxofusp (TAG). PVEK treatment demonstrated promising efficacy, with high and durable CR + CRc responses, and was tolerable at the RP2D. The safety profile was manageable, with no CLS events, predominantly low-grade peripheral edema, and very low incidence of resolvable VOD, a potential TEAE important to monitor during treatment. These results support PVEK as a potential new treatment option for adult pts with BPDCN."

Clinical • Fatigue • Hematological Malignancies • Hepatology • Oncology • CD123 • IL3RA

Efficacy and safety of pivekimab sunirine in blastic plasmacytoid dendritic cell neoplasm in patients with prior or concomitant hematologic malignancy: Results from the cadenza study (ASH 2025) - P1/2 | "For this population of pts with PCHM with complex disease management and limitedtreatment options, response rates and duration of response with PVEK treatment were similar to the denovo BPDCN population in the CADENZA study. Median OS in the overall 1L population was not impactedby pts with PCHM. Importantly, almost half of pts with PCHM transitioned to SCT, despite being older andmore frail, representing a potential breakthrough therapeutic option for this high-risk BPDCN ptsubgroup."

Clinical • Chronic Myelomonocytic Leukemia • CNS Disorders • Hematological Malignancies • Insomnia • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Sleep Disorder • CD123 • IL3RA

Pivekimab Sunirine: First Approval. (PubMed, Drugs) - "On 27 May 2026, pivekimab sunirine received its first approval in the USA for the treatment of adult patients with BPDCN. This article summarizes the milestones in the development of pivekimab sunirine leading to this first approval."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CD123 • IL3RA

REVIVAL: A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2/3 | N=660 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IL3RA

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Acute Myeloid Leukemia; Version 5.2026 (NCCN)

NCCN guideline • Acute Myelogenous Leukemia • Blastic Plasmacytoid Dendritic Cell Neoplasm

THE EFFICACY OF PIVEKIMAB SUNIRINE (PVEK) IN PATIENTS (PTS) WITH BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN) WITH BASELINE SKIN INVOLVEMENT IN THE CADENZA STUDY (EHA 2026) - P1/2 | "Summary/Conclusion Despite high burden of skin involvement among 1L pts with BPDCN, PVEK demonstrated high and durable response rates across pts with both high and low mSWAT, enabling eligible pts to proceed to transplant. These results demonstrate PVEK as a potential new therapeutic option for this pt subgroup."

Clinical • Hematological Malignancies • CD123 • IL3RA

The following studies featuring…etentamig and pivekimab sunirine-pvzy data will…be shared as oral and poster presentations (AbbVie Press Release) - "Etentamig in patients with relapsed/refractory multiple myeloma (RRMM) with prior exposure to B-cell maturation antigen (BCMA)-targeted therapy...Results from Arm B of the MONVISO study (NCT05650632); Longer term safety and efficacy data of etentamig monotherapy in R/R light chain amyloidosis...Updated results from M24-209 (NCT06158854); Efficacy data of pivekimab sunirine-pvzy in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) with baseline skin involvement in the CADENZA study...Post-hoc analysis from CADENZA (NCT03386513)..."

P1 data • P1/2 data • Amyloidosis • Blastic Plasmacytoid Dendritic Cell Neoplasm • Multiple Myeloma

A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2028 ➔ Mar 2030 | Initiation date: Jan 2026 ➔ May 2026

Adverse events • Enrollment open • Trial completion date • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • IL3RA

U.S. FDA Approves DECNUPAZ (pivekimab sunirine-pvzy) for Treatment of Adult Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options (PRNewswire) - "The approval is supported by data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of DECNUPAZ for BPDCN....In the Phase 1/2 CADENZA trial, newly diagnosed patients with BPDCN who were treated with DECNUPAZ demonstrated clinically meaningful and durable responses."

FDA approval • Blastic Plasmacytoid Dendritic Cell Neoplasm

REVIVAL: A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P2/3 | N=660 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2/3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IL3RA

M25-692: A Study to Assess Adverse Events and How Pivekimab Sunirine Moves Through the Body of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrialsregister.eu) - P1 | N=18 | Not yet recruiting | Sponsor: AbbVie Deutschland GmbH & Co. KG

Adverse events • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • IL3RA

NCI-2023-03572: Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Fred Hutchinson Cancer Center | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2029 ➔ May 2029 | Trial primary completion date: Dec 2026 ➔ May 2026

Enrollment closed • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • IL3RA

Anticipating and overcoming resistance in blastic plasmacytoid dendritic cell neoplasm: new insights from pivekimab sunirine. (PubMed, Haematologica) - "Not available."

Journal • Oncology

CADENZA: Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN (clinicaltrials.gov) - P1 | N=155 | Not yet recruiting | Sponsor: ImmunoGen, Inc.

Monotherapy • New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology • IL3RA