Drugs / Pivekimab Sunirine
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07306832 | May 2026 → Apr 2028 expected | acute myeloid leukemia | AbbVie | Recruiting | No outcome recorded |
| Phase 1 | NCT06034470 | Dec 2023 → May 2026 overdue | mixed phenotype acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm | Fred Hutchinson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05320380 | Aug → Sep 2023 | B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, mixed phenotype acute leukemia | Children's Oncology Group | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT04086264 | Nov 2019 → Feb 2027 expected | acute myeloid leukemia | AbbVie | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03386513 | Jan 2018 → Oct 2024 overdue | CD4+/CD56+ hematodermic neoplasm, myeloproliferative neoplasm | AbbVie | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07581002 | Jun 2026 → Jun 2032 expected | acute myeloid leukemia | AbbVie | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | AbbVie | Regulatory 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 abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved DECNUPAZ TM (pivekimab sunirine-pvzy) for the treatment of adult patients with BPDCN, an ultra-rare and aggressive hematologic malignancy with limited treatment options. |
| 2025-09-30 | AbbVie | Regulatory AbbVie Submits Biologics License Application (BLA) to U.S. FDA for Pivekimab sunirine (PVEK) - an Investigational Antibody-Drug Conjugate (ADC) to Treat Rare Cancer with Limited Treatment Options abbvie.com ↗
AbbVie (NYSE: ABBV) today announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). |
| 2023-12-10 | AbbVie | Results ImmunoGen Presents Findings from Newly Diagnosed Acute Myeloid Leukemia Cohorts in Phase 1b/2 Study of Pivekimab Sunirine in Combination with Azacitidine and Venetoclax at ASH abbvie.com ↗
Pivekimab Triplet Demonstrates Encouraging CR, Composite CR, and MRD Negativity Rates; Broad Anti-Leukemia Activity Observed Across All Molecular Subsets Evaluated |
| 2023-06-09 | AbbVie | Results ImmunoGen Presents Updated Findings from CADENZA Trial of Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm at EHA 2023 Congress abbvie.com ↗
today announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN). |
| 2022-12-10 | AbbVie | Results ImmunoGen Presents Findings from Expansion Cohorts in Phase 1b/2 Study of Pivekimab Sunirine with Vidaza® and Venclexta® in Acute Myeloid Leukemia at ASH abbvie.com ↗ |
| 2022-11-04 | AbbVie | Results ImmunoGen Reports Recent Progress and Third Quarter 2022 Financial Results abbvie.com ↗
Turning to pivekimab, our second pivotal program, we reported encouraging initial data from the CADENZA study in frontline BPDCN and look forward to presenting initial data from our triplet expansion cohorts in AML in an oral presentation at ASH. |
| 2022-08-31 | AbbVie | Results ImmunoGen Provides Update on Pivotal CADENZA Study of Pivekimab Sunirine in Frontline Blastic Plasmacytoid Dendritic Cell Neoplasm abbvie.com ↗
In data from the first ten patients in the pivotal CADENZA frontline cohort, the Company observed: 2 of 4 de novo patients achieved CR (complete response)/CRc (clinical complete response); and 4 of 6 PCHM patients achieved CR/CRc/CRh. |
| 2021-12-12 | AbbVie | Results ImmunoGen Presents Initial Findings From the Phase 1b/2 Study of IMGN632 in Combination With Vidaza® and Venclexta® in Relapsed/Refractory Acute Myeloid Leukemia at ASH abbvie.com ↗
Together, the observed anti-leukemia activity and tolerability of IMGN632 in the relapsed/refractory setting are compelling and support the continued evaluation of this triplet in AML patients. |
| 2021-11-04 | AbbVie | Results ImmunoGen to Present Initial Data Combining IMGN632 with Vidaza® and Venclexta® in Relapsed/Refractory Acute Myeloid Leukemia at ASH abbvie.com ↗
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced initial safety and efficacy findings from its Phase 1b/2 study of IMGN632 in combination with Vidaza ® (azacitidine) and Venclexta ® (venetoclax) (triplet) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). |
| 2020-12-05 | AbbVie | Results ImmunoGen Presents Updated Findings from Phase 1/2 Study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm at ASH Annual Meeting abbvie.com ↗
In all relapsed/refractory BPDCN patients, the overall response rate (ORR) was 29% (8/28) with a composite complete remission (CCR) rate of 18% (5/28). |
| 2020-10-05 | AbbVie | Regulatory ImmunoGen Announces FDA Breakthrough Therapy Designation for IMGN632 in Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm abbvie.com ↗
ImmunoGen, Inc. , (Nasdaq: IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). |
| 2019-12-09 | AbbVie | Results ImmunoGen Presents Updated Findings from Phase 1 Study of IMGN632 at ASH Annual Meeting abbvie.com ↗
The data presented at ASH demonstrate the potential of IMGN632 to offer a new treatment option for patients with AML and BPDCN, |
| 2019-11-06 | AbbVie | Results ImmunoGen to Present New Data on IMGN632 at 61st ASH Annual Meeting abbvie.com ↗
A 32% response rate (6/19 patients; two CR, three CRi, and one morphologic leukemia free state) was seen in primary AML patients treated with dose and schedule selected for Phase 2 development. |
| 2018-12-01 | AbbVie | Results ImmunoGen Presents New Data Highlighting Potential of Novel ADCs in Oral Presentations at ASH Annual Meeting abbvie.com ↗
Initial Data for CD123-Targeting IMGN632 Demonstrate Encouraging Anti-Leukemia Activity and Tolerable Safety Profile in Both AML and BPDCN; Dose Exploration Continues |
| 2017-10-16 | AbbVie | Regulatory ImmunoGen Announces Investigational New Drug Application for IMGN632 for Hematological Malignancies is Active abbvie.com ↗ |
All press releases naming this drug 19 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pivekimab Sunirine | “Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody-drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study.” PMID 38423051 ↗ Mar 2024 |
| Known as | IMGN632 | “Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody-drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study.” PMID 38423051 ↗ Mar 2024 |
| Known as | PVEK | “This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA)...” NCT07581002 ↗1“evaluated pivekimab sunirine (PVEK), a novel CD123 antibody-drug conjugate, 0.045 mg/kg once every 3 weeks” PMID 41671533 ↗ Feb 2026 |
| Action | Deplete | “delivers the chemotherapy drug to kill them” NCT05320380 ↗ |
| Modality | Other / unclassified | “CD123-targeted ADC” NCT04086264 ↗ |
| Route | Intravenous | “IMGN632 is administered by IV on Day 1 of each cycle” NCT03386513 ↗ |
| Target | IL3RA | “Interleukin-3 receptor subunit alpha binding agent” CHEMBL4297991 ↗ |