Drugs / Pivekimab Sunirine
Trials 6 · a red edge is where a trial was stopped
| 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leukemia, T-cell acute lymphoblastic leukemia, mixed phenotype acute leukemia | Children's Oncology Group | Withdrawn | No outcome recorded |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 → Sep 2023 overdue | CD4+/CD56+ hematodermic neoplasm, myeloproliferative neoplasm | AbbVie | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07581002 | Jul 2026 → Jun 2032 expected | acute myeloid leukemia | AbbVie | Not yet recruiting | No outcome recorded |
Press releases naming this drug 17 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-27 | AbbVie | 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 ↗ |
| 2025-09-30 | AbbVie | 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 ↗ |
| 2023-12-10 | AbbVie | 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 ↗ |
| 2023-06-09 | AbbVie | ImmunoGen Presents Updated Findings from CADENZA Trial of Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm at EHA 2023 Congress abbvie.com ↗ |
| 2022-12-10 | AbbVie | 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 ↗ |
| 2022-12-09 | AbbVie | ImmunoGen Announces Clinical Collaboration with Gilead to Evaluate Pivekimab Sunirine in Combination with Magrolimab in Relapsed/Refractory Acute Myeloid Leukemia abbvie.com ↗ |
| 2022-08-31 | AbbVie | ImmunoGen Provides Update on Pivotal CADENZA Study of Pivekimab Sunirine in Frontline Blastic Plasmacytoid Dendritic Cell Neoplasm abbvie.com ↗ |
| 2021-12-12 | AbbVie | 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 ↗ |
| 2021-11-04 | AbbVie | ImmunoGen to Present Initial Data Combining IMGN632 with Vidaza® and Venclexta® in Relapsed/Refractory Acute Myeloid Leukemia at ASH abbvie.com ↗ |
| 2020-12-05 | AbbVie | ImmunoGen Presents Updated Findings from Phase 1/2 Study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm at ASH Annual Meeting abbvie.com ↗ |
| 2020-11-30 | AbbVie | ImmunoGen Announces Conference Call to Discuss Recent Updates for IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm and Acute Myeloid Leukemia abbvie.com ↗ |
| 2020-10-05 | AbbVie | ImmunoGen Announces FDA Breakthrough Therapy Designation for IMGN632 in Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm abbvie.com ↗ |
| 2019-12-09 | AbbVie | ImmunoGen Presents Updated Findings from Phase 1 Study of IMGN632 at ASH Annual Meeting abbvie.com ↗ |
| 2019-11-06 | AbbVie | ImmunoGen to Present New Data on IMGN632 at 61st ASH Annual Meeting abbvie.com ↗ |
| 2018-01-04 | AbbVie | ImmunoGen Announces First Patient Dosed in Phase 1 Study of IMGN632 for Hematological Malignancies abbvie.com ↗ |
| 2017-10-16 | AbbVie | ImmunoGen Announces Investigational New Drug Application for IMGN632 for Hematological Malignancies is Active abbvie.com ↗ |
| 2016-12-05 | AbbVie | Preclinical Data on IMGN632, a Novel CD123-Targeting ADC, Presented at ASH Annual Meeting abbvie.com ↗ |
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 ↗ |