Abbvie to highlight early oncology pipeline and biomarker research at AARC 2025

AbbVie announced that new data from its early oncology research will be showcased across multiple presentations at the upcoming American Association of Cancer Research (AACR) Annual Meeting, April 25-30, 2025. 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

“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. 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 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 https://www.clinicaltrials.gov/.

Additional details on key presentations at AACR are available below and the full AACR 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.