艾伯维将在ASH 2025上展示多项最新研发数据

NORTH CHICAGO, Ill., Dec. 2, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data at the 2025 American Society of Hematology (ASH) Congress, showcasing continued advances in research 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). Data across AbbVie's blood cancer portfolio will be featured in multiple oral and poster presentations including investigational compounds etentamig (ABBV-383) and PVEK (pivekimab sunirine), as well as approved therapies EPKINLY® (epcoritamab-bysp) and VENCLEXTA® (venetoclax). 

"These ASH presentations reinforce AbbVie's leadership in advancing the potential next wave of blood cancer innovation, with clinical data that highlight our commitment to raising the standard of care," said Daejin Abidoye, vice president, therapeutic area head, oncology, solid tumor and hematology at AbbVie. "The data also highlights the depth and diversity of our pipeline and portfolio of approved medicines spanning across T-cell engagers, BCL-2 Inhibitors and ADCs, all designed to address the heterogeneity of blood cancers for a range of patients."

Key data from epcoritamab, venetoclax-based treatments, etentamig and PVEK to be highlighted as oral presentations demonstrate promising efficacy, durable responses, and safety profiles across multiple hematologic malignancies and lines of therapy:

Fixed-Duration epcoritamab (CD20×CD3 Bispecific T-Cell Engager) in combination with rituximab and lenalidomide (R2) in Relapsed or Refractory FL

• Results from the randomized phase 3 trial EPCORE FL-1 (NCT05409066) of fixed-duration epcoritamab, in combination with R2 for patients with relapsed or refractory (R/R) FL (n=243) demonstrate significantly superior progression-free survival (PFS) and overall response rates (ORR) compared to standard of care R2 (n=245).1

• The study showed that treatment with epcoritamab + R2 (E+R2) reduced the risk of disease progression or death by 79% compared to standard of care R2, with significantly longer PFS in patients treated with E+R2 vs. those treated with R2 (hazard ratio [HR] 0.21; 95% CI: 0.13, 0.33; P<.0001). A preplanned interim analysis was conducted after the first 232 patients achieved 12 months of follow-up post-randomization, and the ORR was significantly improved in patients treated with E+R2 (95.7% [95% CI: 90.2, 98.6]) vs R2 (81.0% [95% CI: 72.7, 87.7]; P<.0001.1 

• Among patients who were treated with E+R2, 74.5% achieved a complete response (CR) (n=95% CI: 68.5, 79.8) compared to a 43.3% CR rate among patients treated with R2 (n=95% CI: 37.0, 49.7).1

• Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 88.1% of patients receiving E+R2 vs 62.2% with R2, the difference being primarily driven by higher rates of neutropenia (66.3% vs 37.8%) and infections (29.2% vs 13.4%).1 In the E+R2 group, CRS events were at a low grade, and all resolved eventually.1 Recently, EPKINLY in combination with R2 was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with R/R FL.2

Fixed-Duration Venetoclax (BCL-2 Inhibitor) Regimens in Previously Untreated CLL

• Interim data will be showcased from the randomized, Phase 3 CLL17 trial (NCT04608318) conducted and presented by the German CLL Study Group (GCLLSG) comparing continuous ibrutinib (I) monotherapy (n=301) to fixed-duration venetoclax plus obinutuzumab (VO; n=303) and venetoclax plus ibrutinib (VI; n=305) for patients with previously untreated CLL.3 The study was designed to test non-inferiority of VO vs I and VI vs I.3

• After a median follow-up of 34.2 months, the study met non-inferiority endpoints for the VO arm compared to I arm (HR 0.87, type-I-error adjusted CI [98.3%] 0.54-1.41) and for VI arm compared to I arm (HR 0.84, type-I-error adjusted CI [98.0%] 0.53-1.32).3 The 3-year PFS for VO, I and IV arms were 81.1%, 81.0% and 79.4% respectively.3

• The most frequent adverse events (AEs) were infections and infestations (VO: 76.3%, VI: 80.2%, I: 79.9%), gastrointestinal disorders (VO: 59.7%, VI: 74.3%, I: 63.4%), and blood and lymphatic system disorders (VO: 59.0%, VI: 42.9%, I: 28.5%).3

• Venetoclax plus ibrutinib is an investigational combination not approved by the FDA.

Etentamig (Bispecific T-Cell Engager) in R/R MM and AL

• Results from a Phase 1b multi-arm, open-label study evaluating etentamig, a BCMAxCD3 bispecific T-cell engager, (NCT05259839) combined with pomalidomide and dexamethasone (POM+DEX) in 85 heavily pretreated (at least 3 prior lines of therapy) R/R multiple myeloma patients will be presented.4

• Preliminary data from the dose escalation portion of the study (n=82) highlight that etentamig in combination with POM+DEX achieved an ORR of 81% and a very good partial response or better (≥VGPR) of 72% at median follow-up of 23 months (range: 1-33 months).4 In this heavily pretreated population, duration of response (DoR) were not reached at time of analysis.

• Most common grade 3/4 AEs were neutropenia (78%), anemia (28%) and thrombocytopenia (22%).4 Overall, these data support further exploration of the regimen in a randomized Phase 3 study.4

• Additional preliminary data from the dose escalation study with etentamig monotherapy in R/R light chain AL will be showcased as an oral presentation. (NCT06158854)
  
  

PVEK (Antibody Drug Conjugate) in Newly Diagnosed AML

• PVEK is a first-in-class antibody-drug conjugate comprised of a high-affinity anti-CD123 antibody and an indolinobenzodiazepine pseudodimer (IGN) payload. An oral presentation will showcase data from the dose expansion part of an open-label Phase 1b/2 study of PVEK combined with venetoclax and azacitidine (VEN + AZA) in newly diagnosed, CD123-positive AML patients (n=49) who are unfit for intensive chemotherapy (NCT04086264).5 The results show high CR rates of 63.3% with PVEK+VEN+AZA.5 The most common TEAEs (any grade) were neutropenia and thrombocytopenia (both at 69%), constipation (61%) and peripheral edema (51%).5 These data highlight the need to further evaluate this regimen in a randomized trial.5

• A Biologics License Application (BLA) for PVEK was recently submitted to the FDA seeking approval for patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), a rare blood cancer.6   

References:

1. Falchi L, Nijland M, Huang H, et al. Primary Phase 3 results from the epcore FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma. Abstract 224 presented at the American Society of Hematology Congress 2025. Orlando, Florida. 

2. EPKINLY (epcoritamab-bysp) [package insert]. Copenhagen, Denmark: Genmab, 2025.

3. Al-Sawaf O, Stumpf J, Zhang C, et al. Fixed-duration versus continuous targeted treatment for previously untreated chronic lymphocytic leukemia: Results from the randomized CLL17 trial. Abstract 2071 presented at the American Society of Hematology Congress, 2025. Orlando, Florida. 

4. Voorhees P, D'Souza A, Quach H, et al. Etentamig plus pomalidomide-dexamethasone combination therapy in relapsed or refractory multiple myeloma: A phase 1b dose-escalation and safety expansion study. Abstract 1875 presented at the American Society of Hematology Congress, 2025. Orlando, Florida. 

5. Daver N, Advani A, De La Fuente Burguera A, et al. Efficacy and safety of pivekimab sunirine in combination with venetoclax plus azacitidine in unfit patients with newly diagnosed Acute Myeloid Leukemia. Abstract 2524 presented at the American Society of Hematology Congress, 2025. Orlando, Florida. 

6. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070.