AstraZeneca to Present Phase III Cancer Data and Rare Disease Therapy at ASCO 2026

AstraZeneca to Showcase Broad Oncology and Rare Disease Pipeline at ASCO 2026 with Late-Breaking Data Across Liver, Breast, Bladder Cancers and Amyloidosis

AstraZeneca will present a comprehensive slate of late-breaking and oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 29 to June 2, 2026. The company will highlight new data spanning liver, breast, and bladder cancers as well as a potential first-in-class therapy for a rare disease, reinforcing its ambition to transform outcomes across oncology and rare diseases.

The presentations reflect AstraZeneca’s expanding global oncology portfolio, which includes more than 85 abstracts featuring 10 approved medicines and 13 potential new therapies. Across the program, the company will deliver 25 oral presentations and multiple rapid oral and late-breaking sessions, underscoring the depth of its pipeline and its focus on earlier intervention, combination strategies, and novel mechanisms of action.

EMERALD-3: Advancing Immunotherapy in Early Liver Cancer

A major highlight of the ASCO program will be the late-breaking presentation from the EMERALD-3 Phase III trial, evaluating IMFINZI® (durvalumab) in combination with IMJUDO® (tremelimumab-actl), with or without lenvatinib and transarterial chemoembolization (TACE), in patients with unresectable hepatocellular carcinoma (HCC) who are eligible for embolization.

The study is designed to assess whether combining dual immune checkpoint inhibition with established locoregional therapy can improve outcomes in early liver cancer. IMFINZI, a PD-L1 inhibitor, and IMJUDO, a CTLA-4 antibody, represent a combination strategy aimed at enhancing anti-tumor immune responses. The EMERALD-3 data are expected to provide important insights into whether moving immunotherapy earlier in the disease course can meaningfully improve survival and disease control in hepatocellular carcinoma.

SERENA-6, DESTINY-Breast09, and TROPION-Breast02: Expanding Impact in Breast Cancer

AstraZeneca will also present multiple Phase III datasets across the full spectrum of metastatic breast cancer, spanning hormone receptor (HR)-positive, HER2-negative disease, HER2-positive disease, and triple-negative breast cancer (TNBC).

The SERENA-6 Phase III trial will present final progression-free survival 2 (PFS2) outcomes and circulating tumor DNA (ctDNA) clearance data for camizestrant, a next-generation oral selective estrogen receptor degrader (SERD). The therapy is being evaluated in combination with CDK4/6 inhibitors in patients with HR-positive, HER2-negative advanced breast cancer who develop emergent ESR1 mutations. The results will explore how early molecular detection of resistance mutations can guide treatment adaptation and potentially extend disease control.

In HER2-positive metastatic breast cancer, the DESTINY-Breast09 trial will provide exploratory analyses of treatment duration and clinical outcomes stratified by response type, including complete response, partial response, and stable or progressive disease. The study evaluates ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab as a first-line treatment. ENHERTU is an antibody-drug conjugate (ADC) co-developed by AstraZeneca and Daiichi Sankyo, designed to deliver targeted chemotherapy directly to HER2-expressing tumor cells.

In triple-negative breast cancer, the TROPION-Breast02 Phase III trial will present additional efficacy endpoints for DATROWAY® (datopotamab deruxtecan-dlnk), another ADC developed through the AstraZeneca–Daiichi Sankyo collaboration. The study evaluates DATROWAY as a first-line treatment for patients with locally recurrent inoperable or metastatic TNBC who are not eligible for PD-1 or PD-L1 inhibitor therapy. The results are expected to further clarify the role of TROP2-directed therapy in difficult-to-treat breast cancer subtypes.

Together, these datasets reflect AstraZeneca’s strategy of advancing precision oncology across all major breast cancer subtypes, leveraging targeted therapies and biomarker-driven approaches.

CARES Trial: A Potential First-in-Class Therapy in Rare Disease

Beyond oncology, AstraZeneca will present pivotal data from the CARES Phase III clinical program evaluating anselamimab, a potential first-in-class anti-fibril therapy developed by Alexion, AstraZeneca Rare Disease. The study focuses on patients with newly diagnosed light chain (AL) amyloidosis, a rare and life-threatening condition caused by abnormal protein deposits in organs such as the heart and kidneys.

The CARES trial will include results from prespecified subgroup analyses based on kappa (κ) and lambda (λ) free light chain involvement. The therapy is designed to target and deplete amyloid fibrils, addressing a key pathological driver of organ dysfunction in AL amyloidosis. According to AstraZeneca, these results could demonstrate clinically meaningful benefits in survival and reduction of cardiovascular hospitalizations, potentially establishing a new treatment paradigm for this rare disease.

Additional Early-Phase and Translational Programs

AstraZeneca’s ASCO 2026 presence will also include early-phase and translational research across a range of tumor types and novel modalities.

The BLUESTAR Phase I/IIa trial will present updated safety and efficacy data for puxitatug samrotecan (Puxi-Sam), a B7-H4-directed antibody-drug conjugate in patients with relapsed or metastatic endometrial and ovarian cancers. The therapy recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, highlighting its potential in gynecologic malignancies with limited treatment options.

In hematologic malignancies, the PRIMAVERA Phase I trial will provide initial safety and efficacy results for AZD3470, a PRMT5 inhibitor being evaluated in relapsed or refractory classical Hodgkin lymphoma. This represents AstraZeneca’s continued investment in epigenetic and DNA damage response targets in cancer.

Additionally, early clinical data from NT-175, a T-cell receptor therapy targeting TP53 R175H-mutated tumors, will be presented in patients with advanced solid tumors, including pancreatic adenocarcinoma. This program highlights the company’s efforts to develop highly personalized immunotherapies targeting specific oncogenic mutations.

Bladder Cancer: Long-Term Outcomes from POTOMAC

In urothelial carcinoma, AstraZeneca will present five-year overall survival and patient-reported outcomes from the POTOMAC Phase III trial. The study evaluates IMFINZI in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer.

Long-term follow-up data from POTOMAC are expected to provide insight into whether adding immune checkpoint inhibition to standard BCG therapy can improve durable disease control and survival outcomes in early-stage bladder cancer.

Strategic Vision: Moving Cancer Treatment Earlier and Broadening Impact

According to AstraZeneca executives, the ASCO 2026 data reinforce the company’s strategy of moving immunotherapy and targeted therapies into earlier lines of treatment, where they may have the greatest impact on long-term outcomes.

Susan Galbraith, Executive Vice President of Oncology R&D, emphasized that the data from ENHERTU, DATROWAY, and camizestrant reinforce the transformative potential of these therapies across breast cancer subtypes, while also highlighting first clinical data from novel assets such as NT-175 and AZD3470.

Dave Fredrickson, Executive Vice President of Oncology, noted that EMERALD-3 exemplifies the company’s strategy of advancing immunotherapy into earlier stages of liver cancer, with the goal of improving survival outcomes in settings where curative potential may still be achievable.

Gianluca Pirozzi of Alexion highlighted the CARES program as a potential breakthrough in AL amyloidosis, emphasizing its mechanism of targeting and clearing amyloid deposits, which are central to disease progression and organ damage.

Collaboration and Portfolio Expansion

AstraZeneca continues to collaborate with Daiichi Sankyo on several ADC programs, including ENHERTU and DATROWAY, both of which play central roles in the company’s breast cancer strategy. These collaborations reflect a broader industry trend toward precision delivery of cytotoxic agents using antibody-based targeting systems.

AstraZeneca’s ASCO 2026 presentation underscores a broad and rapidly evolving pipeline spanning immunotherapy, antibody-drug conjugates, targeted small molecules, T-cell receptor therapies, and rare disease biologics. With data across liver, breast, and bladder cancers, alongside rare disease innovation in amyloidosis, the company is positioning itself at the forefront of next-generation oncology and precision medicine.

The breadth of late-stage and early-stage data highlights a dual strategy: improving outcomes in established treatment settings while also expanding into earlier disease stages and underserved rare diseases. As ASCO 2026 approaches, investors, clinicians, and researchers will closely watch these datasets for signals of practice-changing potential across multiple tumor types and therapeutic classes.

About AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

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