A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. 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) in adult participants with AML ineligible to receive intensive chemotherapy.
Pivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2/Phase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide.
In Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Start Date30 Jun 2026

Sponsor / Collaborator

AbbVie, Inc.

NCT07306832

/ RecruitingPhase 1

A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R/R) AML.
Pivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.
Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Start Date20 May 2026

Sponsor / Collaborator

AbbVie, Inc.

NCT06034470

/ Active, not recruitingPhase 1

Phase 1 Study of FLAG-Ida With Pivekimab Sunirine (PVEK) for Adults With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

This phase I trial finds the best dose of PVEK when given together with fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin, (FLAG-Ida) regimen and studies the effectiveness of this combination therapy in treating patients with newly diagnosed adverse risk acute myeloid leukemia (AML) and other high-grade myeloid neoplasms. PVEK is a monoclonal antibody linked to a chemotherapy drug. PVEK is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD123 receptors, and delivers the chemotherapy drug to kill them. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. Giving PVEK with the FLAG-Ida regimen may be a safe and effective treatment for patients with acute myeloid leukemia and other high-grade myeloid neoplasms.

Start Date18 Dec 2023

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

100 Clinical Results associated with Pivekimab Sunirine

100 Translational Medicine associated with Pivekimab Sunirine

100 Patents (Medical) associated with Pivekimab Sunirine

Literatures (Medical) associated with Pivekimab Sunirine

02 Dec 2025·EXPERT OPINION ON BIOLOGICAL THERAPY

Current status and future potential of CD123-based targeted therapies for acute leukemia

Review

Author: Aldoss, Ibrahim ; Arslan, Shukaib ; Stein, Anthony ; Aribi, Ahmed

INTRODUCTION:

Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and blastic plasmacytoid dendritic cell neoplasm (BPDCN) are aggressive hematologic malignancies with poor outcomes, particularly in relapsed/refractory settings. CD123, the interleukin-3 receptor alpha chain, is highly expressed on leukemic blasts and leukemia stem cells, making it an attractive therapeutic target with limited expression on normal hematopoietic cells. CD123-directed therapies - including antibody-drug conjugates (ADCs), bispecific T-cell engagers (BiTEs), and CAR T-cell therapies - are under active investigation.

AREAS COVERED:

This review details the preclinical rationale, clinical development, efficacy, and toxicity of CD123-targeted therapies. It discusses completed and ongoing clinical trials for agents such as tagraxofusp, pivekimab sunirine, flotetuzumab, vibecotamab, and investigational CAR T-cell therapies (e.g. MB-102, UCART123v1.2). Toxicities, including myelosuppression, cytokine release syndrome (CRS), and hepatotoxicity - are characterized in detail, with attention to mitigation strategies. Future directions highlight combination regimens, switchable CAR designs, and biomarker-driven personalization.

EXPERT OPINION:

CD123-targeted therapy represents a promising yet challenging frontier in treating high-risk leukemias. While clinical activity has been demonstrated, especially in BPDCN, therapeutic durability and safety remain hurdles. Precision in antigen targeting, combination strategies, and toxicity management will be critical for successful integration of CD123-directed therapies into standard clinical practice.

01 Jan 2025·HemaSphere

The CD123 antibody–drug conjugate pivekimab sunirine exerts profound activity in preclinical models of pediatric acute lymphoblastic leukemia

Article

Author: Lock, Richard B. ; Bult, Carol J. ; Jocoy, Emily L. ; Mohamed, Sara M. A. ; Gifford, Andrew J. ; Evans, Kathryn ; Zweidler‐McKay, Patrick A. ; Philip, Vivek M. ; Lakshmikanthan, Sribalaji ; Neuhauser, Steven ; Smith, Malcolm A. ; Watts, Ben ; Earley, Eric J. ; Erickson, Stephen W. ; Smith, Christopher M. ; Stearns, Timothy M. ; Teicher, Beverly A. ; Chuang, Jeffrey H.

Abstract:

Antibody–drug conjugates (ADCs) combining monoclonal antibodies with cytotoxic payloads are a rapidly emerging class of immune‐based therapeutics with the potential to improve the treatment of cancer, including children with relapse/refractory acute lymphoblastic leukemia (ALL). CD123, the α subunit of the interleukin‐3 receptor, is overexpressed in ALL and is a potential therapeutic target. Here, we show that pivekimab sunirine (PVEK), a recently developed ADC comprising the CD123‐targeting antibody, G4723A, and the cytotoxic payload, DGN549, was highly effective in vivo against a large panel of pediatric ALL patient‐derived xenograft (PDX) models (n = 39). PVEK administered once weekly for 3 weeks resulted in a median event‐free survival (EFS) of 57.2 days across all PDXs. CD123 mRNA and protein expression was significantly higher in B‐lineage (n = 65) compared with T‐lineage (n = 25) ALL PDXs (p < 0.0001), and mice engrafted with B‐lineage PDXs achieved significantly longer EFS than those engrafted with T‐lineage PDXs (p < 0.0001). PVEK treatment also resulted in significant clearance of human leukemia cells in hematolymphoid organs in mice engrafted with B‐ALL PDXs. Notably, our results showed no direct correlation between CD123 expression and mouse EFS, indicating that CD123 is necessary but not sufficient for in vivo PVEK activity. Importantly, a PDX with very high CD123 cell surface expression but resistant to in vivo PVEK treatment, failed to internalize the G4723A antibody while remaining sensitive to the PVEK payload, DGN549, suggesting a novel mechanism of resistance. In conclusion, PVEK was highly effective against a large panel of B‐ALL PDXs supporting its clinical translation for B‐lineage pediatric ALL.

01 Mar 2024·The Lancet. Oncology

Pivekimab sunirine (IMGN632), a novel CD123-targeting antibody–drug conjugate, in relapsed or refractory acute myeloid leukaemia: a phase 1/2 study

Article

Author: Lane, Andrew A ; Du, Yining ; Zweidler-McKay, Patrick A ; Todisco, Elisabetta ; Wang, Eunice S ; Konopleva, Marina Y ; Pemmaraju, Naveen ; DeAngelo, Daniel J ; Papadantonakis, Nikolaos ; Malcolm, Kara E ; Thompson, James E ; Kantarjian, Hagop M ; Montesinos, Pau ; Sloss, Callum M ; Sweet, Kendra L ; Bedse, Gaurav ; Daver, Naval G ; Torres-Miñana, Laura ; Watkins, Krystal

BACKGROUND:

Pivekimab sunirine (IMGN632) is a first-in-class antibody-drug conjugate comprising a high-affinity CD123 antibody, cleavable linker, and novel indolinobenzodiazepine pseudodimer payload. CD123 is overexpressed in several haematological malignancies, including acute myeloid leukaemia. We present clinical data on pivekimab sunirine in relapsed or refractory acute myeloid leukaemia.

METHODS:

This first-in-human, phase 1/2 dose-escalation and dose-expansion study enrolled participants aged 18 years or older at nine hospitals in France, Italy, Spain, and the USA with CD123+ haematological malignancies (Eastern Cooperative Oncology Group performance status of 0-1); participants reported here were in a cohort of participants with acute myeloid leukaemia who were refractory to or had relapsed on one or more previous treatments for acute myeloid leukaemia. The 3 + 3 dose-escalation phase evaluated two dosing schedules: schedule A (once every 3 weeks, on day 1 of a 3-week cycle) and fractionated schedule B (days 1, 4, and 8 of a 3-week cycle). The dose-expansion phase evaluated two cohorts: one cohort given 0·045 mg/kg of bodyweight (schedule A) and one cohort given 0·090 mg/kg of bodyweight (schedule A). The primary endpoints were the maximum tolerated dose and the recommended phase 2 dose. Antileukaemia activity (overall response and a composite complete remission assessment) was a secondary endpoint. The study is ongoing and registered with ClinicalTrials.gov, NCT03386513.

FINDINGS:

Between Dec 29, 2017, and May 27, 2020, 91 participants were enrolled (schedule A, n=68; schedule B, n=23). 30 (44%) of schedule A participants were female and 38 (56%) were male; 60 (88%) were White, six (9%) were Black or African American, and two (3%) were other races. Pivekimab sunirine at doses of 0·015 mg/kg to 0·450 mg/kg in schedule A was administered in six escalating doses with no maximum tolerated dose defined; three dose-limiting toxicities were observed (reversible veno-occlusive disease; 0·180 mg/kg, n=1 and 0·450 mg/kg, n=1; and neutropenia; 0·300 mg/kg, n=1). Schedule B was not pursued further on the basis of comparative safety and antileukaemia findings with schedule A. The recommended phase 2 dose was selected as 0·045 mg/kg once every 3 weeks. At the recommended phase 2 dose (n=29), the most common grade 3 or worse treatment-related adverse events were febrile neutropenia (three [10%]), infusion-related reactions (two [7%]), and anaemia (two [7%]). Treatment-related serious adverse events occurring in 5% or more of participants treated at the recommended phase 2 dose were febrile neutropenia (two [7%]) and infusion-related reactions (two [7%]). Among 68 participants who received schedule A, one death (1%) was considered to be treatment-related (cause unknown; 0·300 mg/kg cohort). At the recommended phase 2 dose, the overall response rate was 21% (95% CI 8-40; six of 29) and the composite complete remission rate was 17% (95% CI 6-36; five of 29).

INTERPRETATION:

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.

FUNDING:

ImmunoGen.

News (Medical) associated with Pivekimab Sunirine

31 Jul 2026

·www.prnewswire.com

AbbVie Reports Second-Quarter 2026 Financial Results

Reports Second-Quarter Diluted EPS of $2.03 on a GAAP Basis, an Increase of 290.4 Percent; Adjusted Diluted EPS of $3.65, an Increase of 22.9 Percent; These Results Include an Unfavorable Impact of $0.17 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $16.990 Billion, an Increase of 10.2 Percent on a Reported Basis or 9.5 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $8.786 Billion, an Increase of 15.1 Percent on a Reported Basis, or 14.6 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $5.505 Billion; Global Rinvoq Net Revenues Were $2.525 Billion; Global Humira Net Revenues Were $756 Million Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $3.228 Billion, an Increase of 20.3 Percent on a Reported Basis, or 19.8 Percent on an Operational Basis; Global Vraylar Net Revenues Were $1.071 Billion; Global Botox Therapeutic Net Revenues Were $1.042 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $742 Million; Global Vyalev Net Revenues Were $256 Million Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.650 Billion, a Decrease of 1.5 Percent on a Reported Basis, or 2.4 Percent on an Operational Basis; Global Venclexta Net Revenues Were $771 Million; Global Imbruvica Net Revenues Were $532 Million; Global Elahere Net Revenues Were $211 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.282 Billion, an Increase of 0.3 Percent on a Reported Basis, or a Decrease of 0.9 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $728 Million; Global Juvederm Net Revenues Were $245 Million Announced Definitive Agreement to Acquire Apogee Therapeutics, Deepening AbbVie's Immunology Portfolio Updates 2026 Adjusted Diluted EPS Guidance Range from $13.91 - $14.11 to $13.87 - $14.07; Now Includes a $0.14 per Share Dilutive Impact Related to the Proposed Acquisition of Apogee Therapeutics, Which is Anticipated to Close in the Third Quarter of 2026; Includes an Unfavorable Impact of $0.58 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2026 NORTH CHICAGO, Ill., July 31, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2026. "AbbVie delivered another excellent quarter, marked by outstanding execution and pipeline advancement. We also announced the proposed acquisition of Apogee Therapeutics, which strengthens our ability to deliver innovative medicines to patients, bolsters our immunology leadership and creates significant shareholder value," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based on our substantial momentum, AbbVie's long-term outlook remains very strong." Second-Quarter Results Worldwide net revenues were $16.990 billion, an increase of 10.2 percent on a reported basis, or 9.5 percent on an operational basis. Global net revenues from the immunology portfolio were $8.786 billion, an increase of 15.1 percent on a reported basis, or 14.6 percent on an operational basis. Global Skyrizi net revenues were $5.505 billion, an increase of 24.4 percent on a reported basis, or 24.0 percent on an operational basis. Global Rinvoq net revenues were $2.525 billion, an increase of 24.5 percent on a reported basis, or 23.7 percent on an operational basis. Global Humira net revenues were $756 million, a decrease of 35.9 percent on a reported basis, or 36.1 percent on an operational basis. Global net revenues from the neuroscience portfolio were $3.228 billion, an increase of 20.3 percent on a reported basis, or 19.8 percent on an operational basis. Global Vraylar net revenues were $1.071 billion, an increase of 18.9 percent. Global Botox Therapeutic net revenues were $1.042 billion, an increase of 12.2 percent on a reported basis, or 11.6 percent on an operational basis. Global Ubrelvy net revenues were $392 million, an increase of 16.0 percent on a reported basis, or 15.9 percent on an operational basis. Global Qulipta net revenues were $350 million, an increase of 30.9 percent on a reported basis, or 30.3 percent on an operational basis. Global Vyalev net revenues were $256 million. Global net revenues from the oncology portfolio were $1.650 billion, a decrease of 1.5 percent on a reported basis, or 2.4 percent on an operational basis. Global Venclexta net revenues were $771 million, an increase of 11.6 percent on a reported basis, or 9.6 percent on an operational basis. Global Imbruvica net revenues were $532 million, a decrease of 29.4 percent. Global Elahere net revenues were $211 million, an increase of 33.1 percent on a reported basis, or 31.8 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.282 billion, an increase of 0.3 percent on a reported basis, or a decrease of 0.9 percent on an operational basis. Global Botox Cosmetic net revenues were $728 million, an increase of 5.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $245 million, a decrease of 6.0 percent on a reported basis, or 6.6 percent on an operational basis. On a GAAP basis, the gross margin ratio in the second quarter was 74.7 percent. The adjusted gross margin ratio was 84.7 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 21.4 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues. Acquired IPR&D and milestones expense was 1.7 percent of net revenues. On a GAAP basis, the operating margin ratio in the second quarter was 37.9 percent. The adjusted operating margin ratio was 48.3 percent. Net interest expense was $679 million. On a GAAP basis, the tax rate in the quarter was 15.5 percent. The adjusted tax rate was 14.7 percent. Diluted earnings per share (EPS) in the second quarter was $2.03 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.65. These results include an unfavorable impact of $0.17 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie and Apogee Therapeutics announced a definitive agreement under which AbbVie will acquire Apogee and its diverse pipeline of clinical-stage candidates in development across inflammatory and immunological diseases. The proposed acquisition includes zumilokibart (APG777), a late-stage, half-life extended monoclonal antibody targeting IL-13 for atopic dermatitis (AD), as well as APG273, a potential best-in-category long-acting combination targeting IL-13 and thymic stromal lymphopoietin (TSLP) in asthma. The acquisition holds potential for substantial shareholder value creation, with mega-blockbuster peak sales potential across Apogee's pipeline of assets, and is expected to close in the third quarter of 2026. The transaction values Apogee at a total equity value of approximately $10.9 billion. Additional information on the transaction can be found at investors.abbvie.com. AbbVie announced the U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved Skyrizi (risankizumab) for the treatment of children six years of age and older with moderate to severe plaque psoriasis. The FDA also approved Skyrizi for pediatric use in psoriatic arthritis. These approvals were supported by data from Phase 3 OptIMMize clinical trial program. AbbVie announced the EC approved Rinvoq (upadacitinib) for the treatment of adult and adolescent patients with non-segmental vitiligo. With this approval, Rinvoq is the first systemic medication approved in the European Union (EU) for patients with non-segmental vitiligo. This approval is supported by data from the Phase 3 Viti-Up clinical program, in which Rinvoq met both co-primary endpoints, with statistically significant and clinically meaningful improvements in total body and facial repigmentation at week 48, as well as key ranked secondary endpoints. AbbVie announced the EC approved Rinvoq for the treatment of adult and adolescent patients with severe alopecia areata. This approval is supported by data from the Phase 3 UP-AA clinical program, in which Rinvoq met the primary endpoint of severity of alopecia tool score ≤ 20 as well as key secondary endpoints, including improvements in eyebrows and eyelashes, at week 24. At the 2026 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented new data across its gastroenterology portfolio, including 18 abstracts in Crohn's disease (CD) and ulcerative colitis (UC). Presentations included real-world evidence and long-term findings that reinforced the efficacy, safety profile and durability of Skyrizi and Rinvoq in inflammatory bowel diseases (IBD). AbbVie announced the EC approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura. This approval marks the second indication for Aquipta in the EU, where it is now approved as both an acute treatment option for migraine attacks and as a preventive treatment option for adults with chronic or episodic migraine who experience at least four migraine days per month. The approval is supported by data from the Phase 3 ECLIPSE trial, which showed that Aquipta resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and consistent effect across multiple migraine attacks. AbbVie announced the FDA approved Decnupaz (pivekimab sunirine) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and aggressive hematologic malignancy. Decnupaz is the first antibody-drug conjugate (ADC) approved for BPDCN that is initiated in an outpatient setting and marks AbbVie's first ADC approved for blood cancer. The approval is supported by data from the Phase 1/2 CADENZA trial, in which newly diagnosed patients with BPDCN treated with Decnupaz demonstrated clinically meaningful and durable responses. AbbVie announced the EC authorized an expanded label for Venclyxto (venetoclax) to include use in combination with acalabrutinib and use in combination with Imbruvica (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The authorization provides an all-oral, fixed-duration, chemotherapy-free treatment option for patients with CLL and supports the potential for time off treatment. The expanded label is supported by data from the Phase 3 AMPLIFY trial, Phase 3 GLOW trial and Phase 2 CAPTIVATE trial. AbbVie announced the EC granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial, in which fixed-duration Tepkinly plus R2 achieved statistically significant improvement of progression-free survival (PFS) and overall response rates (ORR) compared to R2, with approximately three out of four patients achieving a complete response (CR). This approval marks the first bispecific-based therapy approved in Europe for the treatment of R/R FL in the second-line setting, offering patients a chemotherapy-free option. Tepkinly/Epkinly is being co-developed by AbbVie and Genmab. AbbVie announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of Epkinly (epcoritamab) and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. In the trial, the chemotherapy-free combination of Epkinly plus lenalidomide demonstrated statistically significant and clinically meaningful improvement in PFS. The safety profile of Epkinly when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie announced new data demonstrating the breadth and momentum of its next-generation oncology pipeline. Presentations highlighted the potential of AbbVie's novel topoisomerase 1 inhibitor–based ADC and T‑cell engager platforms within solid tumors and blood cancers, including oral presentations in prostate cancer, small cell lung cancer (SCLC), platinum-resistant ovarian cancer (PROC) and multiple myeloma (MM). At the European Hematology Association (EHA) 2026 Congress, AbbVie presented data that reinforced its leadership and commitment to ongoing research to improve outcomes for people living with blood cancers. Featured data from AbbVie's blood cancer portfolio and pipeline included 21 oral and poster presentations, which highlighted etentamig (ABBV-383), Epkinly and Decnupaz. The presentations also showcased Venclexta (venetoclax) data, including a final analysis of the Phase 3 CLL14 trial which demonstrated that after a median follow-up of 9.2 years, treatment with Venclexta plus obinutuzumab resulted in superior PFS compared to treatment with obinutuzumab plus chlorambucil in previously untreated CLL. Allergan Aesthetics announced the FDA approved Skinvive by Juvederm as the first hyaluronic acid injectable indicated to reduce neck lines for the improvement of neck appearance in adults over the age of 21. This approval is supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study in which participants treated with Skinvive by Juvederm saw a clinically significant improvement in neck lines at one month. This approval represents the second FDA-approved indication for Skinvive by Juvederm, which is also approved to improve skin smoothness of the cheeks in adults. Allergan Aesthetics announced the EC and Health Canada approved Boey (trenibotulinumtoxinE) as the first rapid-onset, short-duration neurotoxin for the temporary improvement of moderate to severe glabellar lines in adults. These approvals are supported by data from two Phase 3 clinical trials, in which Boey demonstrated rapid onset of action as early as eight hours after administration and observed efficacy duration of two to three weeks, with treatment-emergent adverse events similar to placebo. AbbVie announced the EC approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. This approval gives clinicians an option to initiate treatment as soon as acute infection is confirmed and makes Maviret the only treatment approved in the EU for both acute and chronic HCV infection. Full-Year 2026 Outlook AbbVie is updating its adjusted diluted EPS guidance to include the impact of the proposed Apogee Therapeutics acquisition, which is expected to be $0.14 dilutive in 2026, based upon an anticipated close in the third quarter of this year. This dilution is partially offset by $0.10 of overperformance. As a result, AbbVie is updating its adjusted diluted EPS guidance range for the full year 2026 from $13.91 - $14.11 to $13.87 - $14.07, reflecting a change of $0.04 at the midpoint. The company's 2026 adjusted diluted EPS guidance includes an unfavorable impact of $0.58 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2026. This guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2026, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2026 and 2025 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the proposed acquisition of Apogee Therapeutics, Inc. ("Apogee"), including the possibility that such acquisition may not be consummated on the anticipated timeframe or at all, risks related to the ability to realize the anticipated benefits of the proposed acquisition on the anticipated timeframe or at all, risks that the costs to consummate the acquisition or to obtain the anticipated benefits of the proposed acquisition could be greater than expected, the failure to obtain applicable regulatory or Apogee stockholder approval in a timely manner or otherwise, the risk that an event occurs that could give rise to the right of AbbVie or Apogee to terminate the merger agreement, risks related to the ability of AbbVie and Apogee to successfully integrate the businesses and the possibility that such integration may be more difficult, time consuming or costly than expected, risks that the proposed acquisition disrupts Apogee's or AbbVie's current plans and operations and makes it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities due to the proposed transaction, negative effects of the consummation of the proposed acquisition on business or employee relationships or the market price of AbbVie's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the proposed acquisition, the risk that zumilokibart (APG777) or other Apogee pipeline assets may not demonstrate the anticipated success, safety, or efficacy in ongoing or future clinical trials, the risk that positive interim clinical trial results for zumilokibart (APG777) may not be predictive of results in later-stage or larger clinical trials, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to AbbVie's industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's and Apogee's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information; and Item 1A, "Risk Factors," of Apogee's most recently filed Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and in other documents that Apogee subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 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AbbVie Presents New Data Across Its Blood Cancer Portfolio at EHA 2026

Data being presented, including six oral presentations, reinforce AbbVie's leadership and commitment to ongoing research to improve outcomes for people living with blood cancers NORTH CHICAGO, Ill. , June 8, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will share new data at the European Hematology Association (EHA) 2026 Congress and will showcase clinical advancements from research programs across multiple blood cancers, including multiple myeloma (MM), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and amyloidosis (AL). Featured data from AbbVie's blood cancer portfolio and pipeline include 21 oral and poster presentations, highlighting the investigational compound etentamig (ABBV-383), and approved therapies, EPKINLY ® (epcoritamab-bysp) (TEPKINLY ® in the EU), VENCLEXTA ® (venetoclax) (VENCLYXTO ® in the EU) and DECNUPAZ™ (pivekimab sunirine-pvzy). "The compelling data we are presenting at EHA reflect AbbVie's robust portfolio and pipeline and our ongoing work to advance the treatment and understanding of hematologic cancers," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "With this research, we continue our commitment to pioneering innovative solutions that have the potential to elevate standards of care for patients and help address the most pressing challenges in treating blood cancers." Key oral presentations of epcoritamab data include: Treatment impact of epcoritamab with lenalidomide and rituximab in relapsed or refractory (R/R) FL A subgroup analysis of the Phase 3 EPCORE FL-1 trial ( NCT05409066 ) of fixed-duration epcoritamab, in combination with rituximab plus lenalidomide (E+R 2 ) for patients with R/R FL (n=243), was performed to determine if the efficacy benefit and tolerability of E+R 2 extended across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared to R 2 . 1 Between Follicular Lymphoma International Prognostic Index (FLIPI) subgroups, overall response rate (ORR) was numerically higher with E+R 2 compared to R 2 (FLIPI 0–2, 96.5% vs 84.8%; FLIPI 3–5, 93.0% vs 72.6%). 1 A similar trend was seen in those with progression of disease less than or equal to two years from the date of initial frontline therapy (POD24). 1 Across the age subgroups, ORR and complete response rates (CRR) for E+R 2 and R 2 for ≥65 were (94.3% vs 80.2% and 80.7% vs 44.3%, respectively) and <65 (95.5% vs 78.4% and 83.9% vs 54.0%, respectively). Progression-free survival (PFS) hazard ratios (HRs) (95% CIs) for E+R 2 and R 2 for the NHL-5 low co-morbidity index score were (0.27 [0.17–0.42]) and NHL-5 high + intermediate were (0.14 [0.06–0.29]). 1 The E+R 2 safety pro all subgroups was consistent with the overall trial population, with no new safety signals. 1 Efficacy data of epcoritamab following systemic therapy in R/R large B-cell lymphoma ( LBCL) EPCORE DLBCL-1 ( EudraCT No. 2020-003016-27 ) is a randomized Phase 3 trial in R/R LBCL evaluating epcoritamab, a CD3×CD20 bispecific antibody, monotherapy. The study showed a statistically significant improvement in PFS versus investigator's choice of chemoimmunotherapy (CIT) — either rituximab plus gemcitabine plus oxaliplatin or bendamustine plus rituximab (HR 0.74 [95% CI, 0.60–0.92]; P=0.0059; 24-month PFS: 30% vs 13%). The study did not demonstrate a statistically significant improvement in overall survival (OS) (HR: 0.96 [95% CI, 0.77–1.20]). There was no OS detriment per pre-specified criteria.* 2 Epcoritamab reported a CRR of 38% and CIT 26%; (nominal P value 0.0032), duration of response (DOR) (median DOR 37 vs 6 months; duration of complete response (DOCR) NR vs 11 months, respectively) and time to next treatment (TTNT) (7 vs 4 months, respectively; nominal P value <0.0001). 2 Higher rates of grade 3–4 infections (30% vs 12%) and any-grade COVID-19 (36% vs 11%) were reported in the epcoritamab arm. Grade 5 treatment-emergent adverse events (TEAEs) occurred in 17% vs 6% (exposure-adjusted, 1.5 vs 1.8 per 100 pt-mo) and were largely attributable to grade 5 COVID-19 (9% vs 2%). 2 *OUS the protocol and SAP were amended to include dual primary endpoints of OS and PFS The following studies featuring venetoclax, etentamig and pivekimab sunirine-pvzy data will also be shared as oral and poster presentations: Predicted efficacy of venetoclax-based therapies in CLL based on genetic biomarkers Results from the Phase 3 GAIA/CLL13 ( NCT02950051 ) trial evaluating fixed-duration venetoclax-based combinations (with rituximab, obinutuzumab and obinutuzumab plus ibrutinib) as a chemotherapy-free alternative to chemoimmunotherapy (fludarabine, cyclophosphamide and rituximab or bendamustine and rituximab) in fit, previously untreated CLL patients lacking del(17p) or TP53 mutations. 3 Venetoclax in combination with rituximab and obinutuzumab plus ibrutinib in previously untreated CLL patients lacking del(17p) or TP53 mutations are investigational combinations not approved in the EU. Efficacy and safety data of venetoclax-obinutuzumab combination in previously untreated CLL Results from the open-label Phase 3 CLL14 trial ( NCT02242942 ) comparing the efficacy and safety of venetoclax in combination with obinutuzumab to obinutuzumab plus chlorambucil in previously untreated patients with CLL and coexisting medical conditions. 4 Real-world management practices with venetoclax-based therapy for AML Results from the prospective observational study, REVIVE ( NCT03987958 ), examining the effect of antimicrobial prophylaxis, post-remission administration of G-CSF and treatment initiation setting on safety and effectiveness outcomes with venetoclax plus hypomethylating agents (HMA) in newly diagnosed AML patients unfit for intensive chemotherapy. 5 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 ), evaluating a flat dose of etentamig in patients with RRMM with at least two prior lines of therapy, including triple-class and prior BCMA exposure. The Phase 1b study is assessing dose optimization and safety. 6 Etentamig is an investigational therapy not approved in the EU. Longer term safety and efficacy data of etentamig monotherapy in R/R light chain amyloidosis Updated results from M24-209 ( NCT06158854 ), evaluating etentamig monotherapy in BCMA-targeted therapy-naïve patients with relapsed/refractory immunoglobulin light chain amyloidosis. The open-label Phase 1/2 study is assessing dose escalation safety and efficacy. 7 Etentamig is an investigational therapy not approved in the EU. 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 ), evaluating the first-line use of pivekimab sunirine-pvzy in patients with BPDCN and varying degrees of skin involvement. The open-label Phase 1/2 study is assessing overall response rate, overall survival and percentage of eligible patients approved to proceed with a stem cell transplant. 8 Pivekimab sunirine-pvzy is an investigational therapy not approved in the EU. Details on key oral and poster presentations at the EHA 2026 Congress are available below and the full abstracts are available here . Oral Presentations: Title Date/Time Session Abstract/ Presentation Number Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R 2 ) in R/R Follicular Lymphoma (FL) Thursday, June 11, 17:45 - 18:00 CEST Oral Session, K1 Hall EHA-3041 Short: S229 Results from EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator's Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL) Friday, June 12, 17:15 - 17:30 CEST Oral Session, Nobel Hall EHA-2409 Short: S235 Venetoclax-obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Final Results of the Randomized CLL14 Study Friday, June 12, 17:30 - 17:45 CEST Oral Session, AE1 Hall EHA-2488 Short: S146 Genetic Biomarkers Predicting Sustained Efficacy of Venetoclax-based Therapies or CIT in Chronic Lymphocytic Leukemia: Final 5-year Analysis of the GAIA/CLL13 Trial Friday, June 12, 18:15 - 18:30 CEST Oral Session, AE1 Hall EHA-4841 Short: S149 Phase 1 Dose Escalation Safety and Efficacy of Etentamig in Patients with Relapsed or Refractory Light Chain Amyloidosis Friday, June 12, 18:15 - 18:30 CEST Oral Session, Victoria Hall EHA-1134 Short: S209 Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial Sunday, June 14, 11:45 - 12:00 CEST Oral Session, A10-11 Hall EHA-3784 Short: S153 Poster Presentations: Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-2191 Short: PF977 Epcoritamab + R-mini-chop Results In 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-2359 Short: PF1007 Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-2343 Short: PF1069 Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R 2 ) In Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1 Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-3123 Short: PF1081 Real-world Management Practices with Venetoclax-based Therapy For AML - Results from the Prospective REVIVE Study Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-3291 Short: PF536 The Efficacy of Pivekimab Sunirine (PVEK) in Patients (PTS) with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) with Baseline Skin Involvement in the CADENZA Study Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-1950 Short: PF500 Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-1124 Short: PS2035 Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Follicular Lymphoma Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-3065 Short: PS2042 Comparative Analyses of Epcoritamab in Combination with Lenalidomide and Rituximab Vs Obinutuzumab and Bendamustine in Relapsed/Refractory Follicular Lymphoma Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-3140 Short: PS2052 Epcoritamab + Chemoimmunotherapy in Patients with Relapsed/Refractory Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplant: Pooled Results from Arms 4 and 10 of EPCORE NHL-2 Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2303 Short: PS2070 Fixed-duration Epcoritamab Monotherapy Induces High Response and MRD-negativity Rates in Elderly Patients with Newly Diagnosed Large B-cell Lymphoma and Comorbidities: Results from EPCORE DLBCL-3 Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2346 Short: PS2082 Epcoritamab In Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL): Insights from the Real-world Epcoritamab Patient Characteristics and Outcomes Research (Real-epcor) Study Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2202 Short: PS2086 Epcoritamab Plus Lenalidomide and Rituximab Improves or Preserves Health-related Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma Who Had High Symptom Burden or Adverse Events Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2776 Short: PS2497 Quality of Life and Symptoms with Fixed-duration Acalabrutinib + Venetoclax ± Obinutuzumab Vs Chemoimmunotherapy in Treatment-naive Chronic Lymphocytic Leukemia: Patient-Reported Outcomes from AMPLIFY Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-4662 Short: PS1706 Etentamig In Patients (PTS) with Relapsed/Refractory Multiple Myeloma (RRMM) with Prior Exposure to B-cell Maturation Antigen (BCMA)-targeted Therapy Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2799 Short: PS1913 Etentamig (ABBV-383) is an investigational medicine and is not approved by any health authorities worldwide. The safety and efficacy of this medicine is under evaluation as part of ongoing clinical studies. Pivekimab sunirine is not approved in the EU. EPKINLY ® /TEPKINLY ® (epcoritamab) and VENCLEXTA ® /VENCLYXTO ® (venetoclax) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ® /TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA ® /VENCLYXTO ® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Additional information on AbbVie clinical trials is available at . USE & IMPORTANT SAFETY INFORMATION for EPKINLY ® (epcoritamab-bysp) in U.S. What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS) , which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant , your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash , upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide , including Important Warnings. Globally, prescribing information varies. Refer to the individual country product label for complete information. USE & IMPORTANT SAFETY INFORMATION for VENCLEXTA ® (venetoclax tablets) in U.S. Uses VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who: ‒ are 75 years of age or older, or ‒ have other medical conditions that prevent the use of standard chemotherapy. It is not known if VENCLEXTA is safe and effective in children. Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you get symptoms of TLS. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may check again for your risk of TLS and change your dose. Who should not take VENCLEXTA? Patients taking certain medicines during the beginning of VENCLEXTA (when the dose is being slowly increased) are at increased risk of TLS. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects. Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider. Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you: have kidney or liver problems. have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium. have a history of high uric acid levels in your blood or gout. are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA. are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. Females who are able to become pregnant: ‒ Your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA. ‒ Use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. ‒ If you become pregnant or think you are pregnant, tell your healthcare provider right away. are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose. What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit during treatment with VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including: Low white blood cell counts (neutropenia). Your healthcare provider will do blood tests to check your blood count during treatment with VENCLEXTA and may pause dosing of VENCLEXTA or give you medicines to help treat your neutropenia if it is severe. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you get a fever or any signs of infection during treatment with VENCLEXTA. Tell your healthcare provider right away if you get a fever or any signs of an infection during treatment with VENCLEXTA. The most common side effects of VENCLEXTA when used in combination with acalabrutinib in people with CLL or SLL include low white blood cell count, headache, diarrhea, muscle and bone pain, and COVID-19. The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet. The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. Your healthcare provider may temporarily stop VENCLEXTA treatment, decrease your dose, or completely stop treatment if you get severe side effects. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance. Please see full Prescribing Information . Globally, prescribing information varies. Refer to the individual country product label for complete information. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information including BOXED WARNING for DECNUPAZ (pivekimab sunirine-pvzy) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Contacts: Media: Anisha Bagchi Manix Email: anisha.manix@abbvie.com Investors: Liz Shea Email: liz.shea@abbvie.com _________________________________ 1 Tessoulin B, Nijland M, et al. Clinically Relevant Subgroup Analysis From The Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect Of Epcoritamab With Lenalidomide And Rituximab (R²) In R/R Follicular Lymphoma (Fl). Abstract EHA-3041 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 2 Fox C, Inchiappa L, et al. Results From EPCORE DLBCL-1: Randomized Phase 3 Study Of Epcoritamab (Epcor) Vs Investigator's Choice Chemoimmunotherapy (Cit) In Patients With Relapsed/Refractory Large B-Cell Lymphoma (R/R Lbcl). Abstract EHA-2409 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 3 Tausch E, Schneider C, et al. Genetic Biomarkers Predicting Sustained Efficacy of Venetoclax-based Therapies or CIT in Chronic Lymphocytic Leukemia: Final 5-yr Analysis of the GAIA/CLL13 Trial. Abstract EHA-4841 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 4 Fischer K, Al-Sawaf O ,et al. Venetoclax-obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Final Results of the Randomized CLL14 Study. Abstract EHA-2488 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 5 Moshe Y, Wolach O, et al. Real-world Management Practices with Venetoclax-based Therapy For AML- Results from the Prospective REVIVE Study. Abstract EHA- 3291 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 6 Chhabra S, Searle E, et al. Etentamig In Patients with Relapsed/Refractory Multiple Myeloma (RRMM) with Prior Exposure to B-cell Maturation Antigen (BCMA)-targeted Therapy. Abstract EHA-2799 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 7 Kastritis E, Huart A, et al. Phase 1 Dose Escalation Safety and Efficacy of Etentamig in Patients with Relapsed or Refractory Light Chain Amyloidosis. Abstract EHA-1134 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 8 Pemmaraju N, Marconi G, et al. Efficacy of pivekimab sunirine-pvzy in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) with baseline skin involvement in the CADENZA study Abstract EHA-1950 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. View original content: SOURCE AbbVie

Clinical ResultPhase 3Phase 1Drug ApprovalPhase 2

28 May 2026

·allsci.com

AbbVie’s CD123 ADC Decnupaz gets FDA nod in rare blood cancer BPDCN

AbbVie (NYSE: ABBV) has received US FDA approval for Decnupaz (pivekimab sunirine-pvzy), an antibody-drug conjugate (ADC) targeting CD123, for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval marks the first ADC cleared by the FDA for this ultra-rare hematologic malignancy and represents AbbVie’s first ADC approval in blood cancer. It also marks the first molecule to emerge with approval from AbbVie’s 2023 USD 10.1 billion acquisition of ImmunoGen, which originally discovered and developed pivekimab sunirine. Decnupaz is approved broadly for adult patients with BPDCN, without restriction by line of therapy. A notable feature of the approval is that treatment can be initiated in an outpatient setting, distinguishing it from more intensive inpatient regimens historically used in this disease. The drug carries a boxed warning for hepatotoxicity, including hepatic veno-occlusive disease, which can be severe or fatal. Additional warnings cover infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity. The approval is supported by data from the Phase I/II CADENZA trial (NCT03386513), a multicenter, open-label study evaluating pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including both newly diagnosed and relapsed or refractory BPDCN. Results were published in the Journal of Clinical Oncology. Among 33 newly diagnosed patients without central nervous system involvement, the composite complete response rate was 69.7%, with a median duration of response of 9.7 months; 13 patients (39.4%) subsequently received stem cell transplant. In the relapsed or refractory cohort of 51 patients, the composite complete response rate was 15.7%, with a median duration of response of 9.2 months, and 6 patients (11.8%) proceeded to transplant. The most common adverse reactions occurring in 20% or more of patients included edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. Decnupaz delivers its cytotoxic effect through CD123-directed antibody-drug conjugate biology. CD123, the alpha subunit of the interleukin-3 receptor, is overexpressed on BPDCN cells, providing a cell-surface target for selective drug delivery. Upon binding and internalization, the conjugated payload — an indolinobenzodiazepine pseudodimer — alkylates DNA and induces single-strand breaks without crosslinking, triggering apoptosis. This mechanism differs from the protein synthesis inhibition employed by the only other approved BPDCN-specific therapy, tagraxofusp-erzs (Elzonris), which uses a CD123-directed IL-3 diphtheria toxin fusion protein. Developed by Stemline Therapeutics and now part of the Menarini Group, tagraxofusp received FDA approval in December 2018 as the first therapy approved specifically for BPDCN. Decnupaz’s outpatient initiation profile and ADC modality add a differentiated option to a therapeutic landscape that, until now, comprised a single approved agent alongside off-label chemotherapy regimens. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Drug ApprovalADCImmunotherapyClinical ResultAcquisition

100 Deals associated with Pivekimab Sunirine

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Blastic Plasmacytoid Dendritic Cell Neoplasm	United States	AbbVie, Inc.	27 May 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 3	United States	AbbVie, Inc.	30 Jun 2026
Acute Myeloid Leukemia	Phase 3	Israel	AbbVie, Inc.	30 Jun 2026
Acute Myeloid Leukemia	Phase 3	South Korea	AbbVie, Inc.	30 Jun 2026
Acute Myeloid Leukemia	Phase 3	Taiwan Province	AbbVie, Inc.	30 Jun 2026
Recurrent B Acute Lymphoblastic Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Recurrent Mixed Phenotype Acute Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory acute myeloid leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory B Acute Lymphoblastic Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory Mixed Phenotype Acute Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023
Refractory T Acute Lymphoblastic Leukemia	Phase 2	-	ImmunoGen, Inc.	01 Aug 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03386513 (CADENZA, ASH2025)	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm First line	11	Pivekimab sunirine 0.045 mg/kg (Prior or concomitant hematologic malignancy)	zvdesyqukr(ioswtepnkr) = kdynstlutd qqaobznmce (dxsgedqbwc, 8.3 - NR) View more	Positive	06 Dec 2025
ASH2025	Phase 1/2	Acute Myeloid Leukemia First line CD123-positive	49	Pivekimab sunirine+Venetoclax+Azacitidine	gfnqlywesm(xutcmjinov) = flialikyjh sgvcyaqbyn (nphhwxvmnv, 48.3 - 76.6) View more	Positive	06 Dec 2025
NCT03386513 (CADENZA, ASCO2025) Manual	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm Interleukin-3 Receptor Subunit Alpha Positive	84	Pivekimab sunirine 0.045 mg/kgPivekimab sunirine 0.045 mg/kg (1L treatment)	eatcvwkndi(mausxbcrml) = rokhhkzqdx nkcumjjfft (tqizbkymfu, 51.3 - 84.4) View more	Positive	30 May 2025
NCT03386513 (CADENZA, ASCO2025) Manual	Phase 1/2		84	Pivekimab sunirine 0.045 mg/kgPivekimab sunirine 0.045 mg/kg (relapsed/refractory pts received 1-3 lines)	eatcvwkndi(mausxbcrml) = wtvjlqkzjy nkcumjjfft (tqizbkymfu ) View more	Positive	30 May 2025
NCT03386513 (CADENZA, EHA2025)	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm CD123 (IL-3Rα)	84	Pivekimab Sunirine (PVEK) 0.045 mg/kg	dulkdhfyzo(nbexgazvnc) = jxbpgxmcmz pvazruczdo (zgpvtznaky, 51.3 - 84.4) View more	Positive	22 May 2025
EHA2024	Phase 1/2	CD123 Positive Acute Myeloid Leukemia CD123-positive	-	Pivekimab sunirine (PVEK)	lidhpofqmg(fvtmqnbzkm) = apmlznrqod zdobarneng (ifdrlwdqfw )	-	14 May 2024
NCT03386513 (Literature) Manual	Phase 1/2	Acute Myeloid Leukemia Interleukin-3 Receptor Subunit Alpha Positive	91	IMGN632	gmxbdwnata(ofqzzdbtwc) = prvsxtlfde vvyjsewmiu (tmculkpinf ) View more	Positive	01 Mar 2024
ASH2023	Phase 1/2	Acute Myeloid Leukemia	50	Pivekimab Sunirine (PVEK)	wfpmqibtye(lhrmbhrkzo) = guddfdrvar vsnkcqcpeb (uflsatbbhq ) View more	-	10 Dec 2023
NCT04086264 (ASH 12022 \| ASH 22022) Manual	Phase 1/2	Relapsing acute myeloid leukemia	71	Azacitidine+Venetoclax+Pivekimab Sunirine	aatabqxoyi(vkzxqligfc) = txnkihjzzg krogdgqijc (huceqgqvym ) View more	Positive	15 Nov 2022
NCT04086264 (AML-262, Pubmed \| Clin Lymphoma Myeloma Leuk)	Phase 1/2	Relapsing acute myeloid leukemia	-	Pivekimab sunirine (PVEK)	rjknkxsthh(vheapobxgm) = IRRs were reported in 33% (n=17, one grade 4) of patients given 1 dose of dexamethasone (8 mg) as premedication (n=51); these IRRs were most frequently tachycardia and chills, with no anaphylactic reactions reported. Following the data cut-off, there was a second grade 4 IRR, and the prophylactic regimen was increased with two additional doses of dexamethasone on the day prior to the PVEK dose. The IRR rate has dropped to 8% (3 of 38), with no grade 3+; all were grades 1-2 that resolved with limited intervention (P<0.01) kbffxxpdip (kdeztjphjx )	-	01 Oct 2022
NCT03386513 (CADENZA, Corporate Publications) Manual	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm	10	pivekimab (de novo patients)	dwnvtuobwz(exsssoexoj) = nzfaxfmcbn jpaotyfglj (mciuffymvb )	Positive	31 Aug 2022
NCT03386513 (CADENZA, Corporate Publications) Manual	Phase 1/2	Blastic Plasmacytoid Dendritic Cell Neoplasm	10	pivekimab (PCHM patients)	ewflpvnuqu(udclkpcvgc) = njqgfiltfr qnlvbiiokq (jgfnkfslrs )	Positive	31 Aug 2022

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