AbbVie Presents Breakthrough Data at ASH 2025 Demonstrating Significant Advances in Blood Cancer Treatment
核心洞察
AbbVie (搜索) unveiled compelling clinical data at ASH 2025 showcasing advances across multiple blood cancer therapeutic modalities including T-cell engagers, BCL-2 (搜索) inhibitors, and antibody-drug conjugates.
The phase 3 EPCORE FL-1 trial demonstrated that epcoritamab plus rituximab and lenalidomide reduced disease progression risk by 79% in relapsed/refractory follicular lymphoma (搜索) patients.
Investigational therapies etentamig and PVEK (搜索) showed promising efficacy with 81% overall response rates in multiple myeloma (搜索) and 63.3% complete response rates in acute myeloid leukemia (搜索), respectively.
AbbVie (搜索) announced significant clinical advances across its blood cancer portfolio at the 2025 American Society of Hematology (ASH) Congress, presenting data that demonstrates the company's expanding therapeutic arsenal against difficult-to-treat hematologic malignancies. The presentations showcase breakthrough results from both approved therapies and investigational compounds across multiple blood cancers including follicular lymphoma (搜索), chronic lymphocytic leukemia (搜索), multiple myeloma (搜索), and acute myeloid leukemia (搜索).
Phase 3 Success in Follicular Lymphoma
The most striking results came from the randomized phase 3 EPCORE FL-1 trial (NCT05409066), which evaluated fixed-duration epcoritamab in combination with rituximab and lenalidomide (E+R2) versus standard of care R2 in patients with relapsed or refractory follicular lymphoma (搜索). The study enrolled 488 patients (243 in the E+R2 arm, 245 in the R2 arm) and demonstrated remarkable efficacy outcomes.
Treatment with E+R2 reduced the risk of disease progression or death by 79% compared to standard of care R2, with significantly longer progression-free survival (hazard ratio 0.21; 95% CI: 0.13, 0.33; P<.0001). The overall response rate was significantly improved in patients treated with E+R2 (95.7% [95% CI: 90.2, 98.6]) versus R2 (81.0% [95% CI: 72.7, 87.7]; P<.0001).
Among patients treated with E+R2, 74.5% achieved a complete response (95% CI: 68.5, 79.8) compared to a 43.3% complete response rate among patients treated with R2 (95% CI: 37.0, 49.7). The safety profile showed Grade 3/4 treatment emergent adverse events in 88.1% of patients receiving E+R2 versus 62.2% with R2, with the difference primarily driven by higher rates of neutropenia (66.3% vs 37.8%) and infections (29.2% vs 13.4%). Cytokine release syndrome events in the E+R2 group were low grade and all resolved eventually.
Fixed-Duration Venetoclax Demonstrates Non-Inferiority
Interim data from the randomized Phase 3 CLL17 trial (NCT04608318), conducted by the German CLL Study Group, compared continuous ibrutinib monotherapy to fixed-duration venetoclax plus obinutuzumab and venetoclax plus ibrutinib for patients with previously untreated chronic lymphocytic leukemia (搜索). The study enrolled 909 patients across three arms: continuous ibrutinib (n=301), venetoclax plus obinutuzumab (n=303), and venetoclax plus ibrutinib (n=305).
After a median follow-up of 34.2 months, the study met non-inferiority endpoints for both venetoclax-containing arms compared to ibrutinib. The venetoclax plus obinutuzumab arm showed a hazard ratio of 0.87 (type-I-error adjusted CI [98.3%] 0.54-1.41), while the venetoclax plus ibrutinib arm demonstrated a hazard ratio of 0.84 (type-I-error adjusted CI [98.0%] 0.53-1.32). The 3-year progression-free survival rates were 81.1%, 81.0%, and 79.4% for the venetoclax plus obinutuzumab, ibrutinib, and venetoclax plus ibrutinib arms, respectively.
Promising Pipeline Advances
Etentamig in Multiple Myeloma
Results from a Phase 1b study evaluating etentamig, a BCMAxCD3 bispecific T-cell engager, combined with pomalidomide and dexamethasone in heavily pretreated relapsed or refractory multiple myeloma (搜索) patients showed encouraging efficacy. In 82 patients who had received at least three prior lines of therapy, the combination achieved an overall response rate of 81% and a very good partial response or better rate of 72% at a median follow-up of 23 months.
The most common grade 3/4 adverse events were neutropenia (78%), anemia (28%), and thrombocytopenia (22%). Duration of response had not been reached at the time of analysis, supporting further exploration in a randomized Phase 3 study.
PVEK Shows Promise in Acute Myeloid Leukemia
PVEK (搜索), a first-in-class antibody-drug conjugate comprising a high-affinity anti-CD123 (搜索) antibody and an indolinobenzodiazepine pseudodimer payload, demonstrated significant activity in newly diagnosed acute myeloid leukemia (搜索). Data from the dose expansion portion of a Phase 1b/2 study showed that PVEK combined with venetoclax and azacitidine achieved complete response rates of 63.3% in 49 CD123-positive AML patients unfit for intensive chemotherapy.
The most common treatment emergent adverse events were neutropenia and thrombocytopenia (both at 69%), constipation (61%), and peripheral edema (51%). A Biologics License Application for PVEK (搜索) was recently submitted to the FDA seeking approval for patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (搜索), a rare blood cancer.
Clinical Impact and Future Directions
"These ASH presentations reinforce AbbVie (搜索)'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 (搜索) Inhibitors and ADCs, all designed to address the heterogeneity of blood cancers for a range of patients."
The comprehensive data package represents AbbVie (搜索)'s expanding capabilities across multiple therapeutic modalities, from bispecific T-cell engagers to BCL-2 (搜索) inhibitors and antibody-drug conjugates. EPKINLY in combination with rituximab and lenalidomide was recently approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (搜索), while etentamig and PVEK (搜索) remain investigational compounds under evaluation in ongoing clinical studies.