• Data for ABBV-969, a novel STEAP1/PSMA dual-targeted antibody-drug conjugate (ADC) in Phase 1 for advanced prostate cancer, will be presented in an oral presentation.
• Data to be presented on ABBV-514, a novel CCR8 targeting antibody, in Phase 1 for non-small cell lung cancer, head and neck cancer and other solid tumors.
• Other presentations highlight key insights into treatment resistance and biomarker identification based on real-world-data analyses.

NORTH CHICAGO, Ill., March 26, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today 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.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 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.

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.^2,7

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. 

About AbbVie in Oncology

At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

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. ClinicalTrials.Gov. NCT06318273. 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. Available online. Accessed March 2025.
7. ClinicalTrials.Gov. NCT05005403. 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. Available online. Accessed March 2025.
8. 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.
9. 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.
10. 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.

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