New data from AbbVie’s early oncology research program 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 agent, including ABBV-969, and ABBV-514, across a range of hard-to-treat tumor types.[1][2]
The company will also present new insights on treatment resistance and novel biomarker identification based on real-world-data analyses. [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,” noted 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,” Ross added.
A novel STEAP1/PSMA dual-targeted ADC
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 (NCT06318273) for men with metastatic castration-resistant prostate cancer (mCRPC).
A novel CCR8-targeting antibody
Data from AbbVie’s immuno-oncology platform highlight the potential of ABBV-514, a novel anti-chemokine C-C motif receptor 8 (CCR8-) targeting antibody, 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 relapsed non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) both as a monotherapy and in combination with budigalimab, a PD-1-blocking antibody (NCT05005403).[2]
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][7][8] 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] This study shows that certain germline variants may serve as predictive biomarkers and help advance precision medicine R&D efforts.[5]
| Title | Date / Time | Session | Abstract |
|---|---|---|---|
| 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 | 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 | 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 | 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 – | Poster Poster Board 19 Session: Genomic Profiling of Tumors 3 | 6638 |
Clinical trials
A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer – ClinicalTrials.gov ID NCT06318273
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab ClinicalTrials.gov ID NCT05005403
References
[1] Reilly R. ABBV-969: A first-in-class dual-targeting PSMA-STEAP1 drug conjugate for the treatment of metastatic castrate-resistant prostate cancer. Abstract ND03 presented at the American Association for Cancer Research Annual Meeting, 2025. Chicago, Illinois.
[2] Paustian AS, Guo L, Feng W, et al. ABBV-514: an afucosylated CCR8 Specific Antibody that Targets and Eliminates Key Immunosuppressive Tumor Regulatory T cells. Abstract 6025 presented at the American Association for Cancer Research Annual Meeting, 2025. Chicago, Illinois.
[3] Wu S, Zhao W, Zhang B, et al. 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. Abstract 3395 presented at the American Association for Cancer Research Annual Meeting, 2025. Chicago, Illinois.
[4] Themeles M, Kolahi K, Mistry A, et al. Characterizing spatial expression patterns and prevalence of folate receptor alpha in relation to other existing and emerging ovarian cancer biomarkers. Abstract 5910 presented at the American Association for Cancer Research Annual Meeting, 2025. Chicago, Illinois.
[5] Wu S, Tsui M, McLaughlin RT, et al. Identifying cancer germline variants associated with patient prognosis and response by applying clinico-genomics data. Abstract 6638 presented at the American Association for Cancer Research Annual Meeting, 2025. Chicago, Illinois.
[6] Italiano A, Cassier PA, Lin CC, et al. First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2022;71(2):417-431.
[7] Markert S, Lassmann S, Gabriel B, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008;28:3567–72.
[8] Kalli KR, Oberg AL, Keeney GL, et al. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecol Oncol. 2008;108:619–26.
Featured image: AbbVie / AACR 2019. © 2019 – 2025 Sunvalley Communication. Ised with permission.
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