AstraZeneca

AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, 31 May to 4 June 2024.

More than 100 abstracts will feature 25 approved and potential new medicines across the Company's diverse oncology portfolio and pipeline, including two late-breaking plenary presentations, a special late-breaking abstract session presentation and 15 oral presentations. Highlights include:

• LAURA Phase III trial of Tagrisso (osimertinib) in unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) (Plenary LBA4).
• ADRIATIC Phase III trial of Imfinzi (durvalumab) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent CRT (cCRT) (Plenary LBA5).
• DESTINY-Breast06 Phase III trial of Enhertu (trastuzumab deruxtecan) in patients with metastatic hormone receptor (HR)-positive HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy (LBA1000).
• First-in-human, investigator-initiated trial of C-CAR031, a novel autologous armoured Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy, in patients with liver cancer. The CAR-T is based on AZD5851, a novel cell therapy designed by AstraZeneca (Rapid Oral Abstract 4019).
• Two late-breaking presentations from the externally sponsored I-SPY2.2 Phase II trial of neoadjuvant datopotamab deruxtecan (Dato-DXd), alone and in combination with Imfinzi, in patients with breast cancer (LBA501 and LBA509).

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our plenary data at ASCO show the pioneering role of our medicines in curative-intent lung cancer treatment and highlight progress toward our continued ambition to have a medicine for more than half of all patients treated for lung cancer by 2030. The overwhelming efficacy in the LAURA trial will add to the extensive body of evidence for Tagrisso in EGFR-mutated non-small cell lung cancer, and the impressive survival data from ADRIATIC will show the potential of Imfinzi to transform outcomes in limited-stage small cell lung cancer."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Data from our antibody drug conjugates at ASCO underscore the opportunity to replace traditional chemotherapy with these medicines for many patients as we expand their use to new populations. DESTINY-Breast06 results will demonstrate the potential to treat patients across a broader spectrum of HR-positive metastatic breast cancer with Enhertu, including those with HER2-ultralow expression who have never had access to HER2-directed therapy before. We're also excited by the I-SPY2.2 efficacy and tolerability data for datopotamab deruxtecan plus Imfinzi, which will show the potential of combining antibody drug conjugates with immunotherapy in the early-stage setting."

Transforming treatment expectations across earlier-stage lung cancer settings

Several presentations will reinforce the Company's progress toward moving lung cancer treatment to earlier stages of disease. These include:

• A late-breaking plenary presentation showcasing progression-free survival (PFS) results from the LAURA Phase III trial evaluating Tagrisso in unresectable, Stage III EGFRm NSCLC after CRT. In February, high-level results showed a statistically significant and highly clinically meaningful PFS benefit for Tagrisso in this setting.
• A late-breaking plenary presentation highlighting overall survival (OS) and PFS results from the ADRIATIC Phase III trial of Imfinzi in patients with LS-SCLC who had not progressed following cCRT. In April, high-level results from an interim analysis showed a statistically significant and clinically meaningful OS and PFS benefit for Imfinzi in this setting.
• An oral presentation of an analysis from the ADAURA Phase III trial of Tagrisso in the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC, assessing the potential for circulating tumour DNA-based molecular residual disease to predict disease recurrence.
• A rapid oral presentation of an exploratory analysis from the AEGEAN Phase III trial of Imfinzi-based treatment before and after surgery in patients with resectable early-stage (IIA-IIIB) NSCLC, evaluating efficacy in patients with N2 disease (cancer in the lymph nodes on the same side as the affected lung or between the lungs).
• A poster presentation of updated OS, PFS and safety results from the COAST Phase II trial of Imfinzi in combination with novel immunotherapies oleclumab, an anti-CD73 monoclonal antibody, and monalizumab, an anti-NKG2A monoclonal antibody, in unresectable, Stage III NSCLC, supporting the PACIFIC-9 Phase III trial in this patient population.

In metastatic lung cancer, the Company will present data that underscore its commitment to extending the benefits of antibody drug conjugates (ADCs) to more patients. A poster presentation will share updated safety and efficacy results, including by PD-L1 expression, from the TROPION-Lung02 Phase Ib trial of datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations. These data build on previously presented results from the TROPION-Lung01 Phase III trial demonstrating the potential of this novel ADC in advanced disease. Datopotamab deruxtecan in combination with immunotherapies is being further explored in multiple Phase III trials in this setting, including AVANZAR, TROPION-Lung07 and TROPION-Lung08.

Redefining the breast cancer treatment landscape with ADCs across subtypes and stages of disease

A late-breaking presentation will showcase efficacy and safety outcomes from the DESTINY-Breast06 Phase III trial. In April, high-level results showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in PFS versus standard-of-care chemotherapy in patients with HR-positive, HER2-low metastatic breast cancer. A clinically meaningful PFS improvement was also seen in patients with HER2-ultralow expression.

An oral presentation will spotlight data from an interim analysis of the dose-expansion phase of the DESTINY-Breast07 Phase Ib/II trial assessing Enhertu alone or in combination with pertuzumab as 1st-line treatment in HER2-positive metastatic breast cancer. These regimens are being further explored in the DESTINY-Breast09 Phase III clinical trial.

Additionally, a poster presentation will share updated OS and PFS results from the DESTINY-Breast03 Phase III trial of Enhertu versus trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane.

An oral presentation will feature patient-reported outcomes data from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan in patients with inoperable or metastatic HR-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. Previously presented primary results from TROPION-Breast01 showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS versus investigator's choice of chemotherapy.

Two late-breaking presentations of results from the externally sponsored I-SPY2.2 Phase II trial will highlight the rates of pathologic complete response associated with neoadjuvant datopotamab deruxtecan, alone and in combination with Imfinzi, across breast cancer subtypes.

Advancing the next wave of medicines and combination therapies to attack cancer from multiple angles

A rapid oral presentation will spotlight safety and preliminary efficacy results from an investigator-initiated trial of C-CAR031, a novel autologous armoured Glypican 3 (GPC3) targeting chimeric antigen receptor T cell (CAR-T) therapy that is being investigated for hepatocellular carcinoma. The CAR-T is based on AZD5851, a novel cell therapy designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armouring platform and is manufactured by AbelZeta Pharmaceuticals Inc. C-CAR031 is being developed in China under a co-development agreement between AbelZeta and AstraZeneca. AstraZeneca's TGFβRII dominant negative armouring is designed to resist the immuno-suppressive tumour microenvironment and enhance the potential effectiveness of CAR-Ts in solid tumours.

A rapid abstract update will feature updated efficacy data from a Phase I trial of AZD0901, a potential first-in-class ADC targeting Claudin 18.2, which has shown promise as a therapeutic target in gastric cancer. First results were presented at the ASCO Plenary Series 2023.

Additionally, a clinical science symposium presentation of the externally sponsored CAPRI Phase II trial will share efficacy and safety results for ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus Lynparza (olaparib) in patients with platinum-sensitive recurrent high-grade serous ovarian cancer.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan, and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

Key AstraZeneca presentations during ASCO 2024

Notes

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 catalyse 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.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

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