On March 26, 2025 AbbVie (NYSE: ABBV) reported that new data from its early oncology research will be showcased across multiple presentations at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 25-30, 2025 (Press release, AbbVie, MAR 26, 2025, View Source [SID1234651481]). Presentations include data from novel investigational molecules, ABBV-969 and ABBV-514, across a range of hard-to-treat tumor types.1,2 Additionally, new insights on treatment resistance and novel biomarker identification based on real-world-data analyses are to be presented.3,4,5
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"As we seek to advance innovative therapies for people living with difficult-to-treat cancers, our early-stage oncology research helps lay the scientific foundation for future innovation that may address profound unmet needs that many patients experience," said Theodora S. Ross, M.D., Ph.D., vice president, early oncology research and development, AbbVie. "By harnessing the latest scientific breakthroughs in translational research, we are advancing novel therapeutic approaches such as ABBV-969 and ABBV-514, aiming to improve cancer care for patients worldwide."
Data on ABBV-969, a novel, dual-targeted ADC, with a proprietary, cytotoxic topoisomerase 1 inhibitor (Top1i) payload will be presented in an oral presentation at the meeting.1 ABBV-969 is designed to target tumor cells expressing STEAP1 and/or PSMA antigens.1 Prostate cancer cells may overexpress STEAP1, PSMA or both, and their expression is associated with tumor growth and survival.1 ABBV-969 is currently in a Phase 1 clinical trial for men with metastatic castration-resistant prostate cancer (mCRPC) (NCT06318273).6
Data from AbbVie’s immuno-oncology platform highlight the potential of a novel CCR8-targeting antibody, ABBV-514, in driving anti-tumor immunity.2 CCR8 is a promising target due to its enhanced expression on tumor-infiltrating regulatory T cells (Tregs) and a higher prevalence of these CCR8+ Tregs is associated with poor clinical outcomes in several solid tumor types.2 Preclinical data show that ABBV-514 depletes CCR8+ Tregs inside the tumor and has strong monotherapy activity in a variety of in vivo tumor models, including models that are insensitive to anti-PD-1 treatment.2 ABBV-514 is currently being evaluated in a Phase 1 clinical trial in non-small cell lung cancer (NSCLC), head and neck cancer and other solid tumors, both as a monotherapy and in combination with budigalimab, a PD-1-blocking antibody (NCT05005403).2,7,8
Additional presentations at the AACR (Free AACR Whitepaper) annual meeting will include real-world-data analyses in two key areas of cancer research – treatment resistance and biomarker discovery:
An analysis to characterize the overlap of folate receptor alpha (FRa) expression, a biomarker found in 90 percent of ovarian cancers, with other biomarkers that could potentially help support the development of novel precision medicines.4,9,10 This study provides new insights that could aid treatment matching for patients and inform treatment sequencing and combination therapy options.4
A new study that employed multi-omics approaches to real-world-data analysis, to identify clinical features and molecular mechanisms of long-term response and acquired resistance to immunotherapy in non-small cell lung cancer.3
Data showcasing a novel approach for investigating relationships between germline variants, cancer patient prognosis and treatment responses, using electronic health record-linked genomics data across a range of solid tumor types.5 The study shows that certain germline variants may serve as predictive biomarkers and help advance precision medicine R&D efforts.5
Further information on AbbVie clinical trials is available at View Source
Additional details on key presentations at AACR (Free AACR Whitepaper) are available below and the full AACR (Free AACR Whitepaper) Annual Meeting 2025 abstracts are available here.
Title
Date/Time
Session
Abstract number
ABBV-969: A first-in-class dual-targeting
PSMA-STEAP1 drug conjugate for the
treatment of metastatic castrate-resistant
prostate cancer
April 27, 1:45 –
2:00 PM CT
Oral Presentation
Session: New Drugs on the Horizon: Part 1
ND03
Investigating clinical features and
molecular mechanisms of long-term
response and acquired resistance to
immunotherapy in non-small cell lung
cancer by applying real-world-data
April 28, 2:00 –
5:00 PM CT
Poster
Poster Board 15
Session: Real-World Data and Real-World Evidence: Clinico-Genomics
3395
ABBV-514: an afucosylated CCR8
specific antibody that targets and
eliminates key immunosuppressive
tumor regulatory T cells
April 29, 2:00 –
5:00 PM CT
Poster
Poster Board 20
Session: Therapeutic Antibodies,
Including Engineered
Antibodies 2
6025
Characterizing spatial expression
patterns and prevalence of folate
receptor alpha in relation to other
existing and emerging ovarian cancer
biomarkers
April 29, 2:00 –
5:00 PM CT
Poster
Poster Board 2
Session: Predictive Biomarkers 6 /Diagnostic Biomarkers 3
5910
Identifying cancer germline variants
associated with patient prognosis and
response by applying clinico-genomics
data
April 30, 09:00 AM –
12:00 PM CT
Poster
Poster Board 19
Session: Genomic Profiling of Tumors 3
6638
ABBV-969 and ABBV-514 are investigational medicines and are not approved by any health authority worldwide. Their safety and efficacy are under evaluation as part of ongoing clinical studies.
About ABBV-969
ABBV-969 is an investigational, novel antibody-drug conjugate (ADC) targeting prostate-specific membrane antigen (PSMA) and six transmembrane epithelial antigen of the prostate 1 (STEAP1), being investigated to treat metastatic castration-resistant prostate cancer (mCRPC).1,6 ABBV-969 was designed using a dual variable domain immunoglobulin (DVD-Ig) with a proprietary topoisomerase-1 (Top1) inhibitor linker-drug format.1
About ABBV-514
ABBV-514 is an investigational anti-chemokine C-C motif receptor 8 (CCR8) antibody that is being investigated for the treatment of relapsed non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) both as a monotherapy and in combination with a PD-1 inhibitor.