3 December 2020 07:00 GMT

New data from the DESTINY-Breast01 Phase II trial reinforce the efficacy of Enhertu in HER2-positive metastatic breast cancer New data from the SERENA-1 Phase I trial show strong efficacy and safety profile for next-generation oral SERD AZD9833 in HR-positive advanced breast cancer

AstraZeneca will unveil new developments across a range of stages and subtypes of breast cancer at the 2020 San Antonio Breast Cancer Symposium (SABCS), which will be held virtually from 8 to 11 December 2020. Key abstracts include:

• New data from the DESTINY-Breast01 Phase II trial, which reinforce the durable efficacy seen with?Enhertu?(trastuzumab deruxtecan) in HER2-positive metastatic breast cancer following two or more prior anti-HER2 based regimens
• New results from the SERENA-1 Phase I trial, which demonstrate strong efficacy and safety for a next-generation oral selective oestrogen receptor degrader (SERD), AZD9833 as a monotherapy and in combination with the CDK4/6 inhibitor, palbociclib, in HR-positive, HER2-negative advanced breast cancer

Jos? Baselga, Executive Vice President, Oncology R&D, said: ?We are committed to transforming outcomes for women diagnosed or living with breast cancer by advancing a new generation of promising potential new medicines. The updates from the comprehensive DESTINY breast programme reflect the potential of?Enhertu?to help a wide range of breast cancer patients, while the encouraging data from the SERENA-1 Phase I trial paves the way for a clinical development programme to help patients with hormone receptor-positive disease.? Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: ?Significant progress has been made to improve outcomes for those living with breast cancer but there is still much work to be done. At SABCS 2020, our dedication to transforming the lives of those living with breast cancer will be front and centre. With new updates from six different approved and potential new medicines, we are directly addressing patients? greatest unmet needs and are potentially redefining treatment. Additionally, we are making an impact through collaborations with the scientific community to accelerate innovation.? New, longer-term data from DESTINY-Breast01 to be presented at SABCS will highlight the updated efficacy and safety profiles of?Enhertu?in patients with previously treated HER2-positive metastatic breast cancer with an additional 9.4 months of follow up. Furthermore, AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) will showcase several TiP abstracts that highlight how the companies are building on the impressive results of?Enhertu?in patients with HER2-positive metastatic breast cancer. These include trials to explore the potential of?Enhertu?in earlier lines of treatment and stages of disease and in new breast cancer settings, including patients with low levels of HER2 expression. They also include combinations with other anti-cancer medicines such as paclitaxel,?Faslodex,?Imfinzi?and the potential new medicine capivasertib, an AKT inhibitor. AstraZeneca will present new efficacy and safety results from the dose escalation and expansion cohort of SERENA-1, a Phase I clinical trial of next-generation oral SERD AZD9833 as a monotherapy and in combination with the CDK4/6 inhibitor palbociclib in women with HR-positive breast cancer. Building on the updated SERENA-1 findings, the Company will present two Phase II trial-in-progress (TiP) abstracts for the potential new medicine AZD9833, evaluating its efficacy and safety in previously treated post-menopausal women with advanced breast cancer and its biological effects in women with treatment-na?ve early-stage breast cancer. AstraZeneca is also presenting real-world evidence to understand outcomes for patients with germline BRCA mutations, and treatment patterns among patients with HER2-positive metastatic breast cancer. The Company will also showcase data on the potential role of artificial intelligence and digital pathology in measuring levels of HER2 expression in patients with breast cancer. Additionally, AstraZeneca recognises the important role of externally sponsored scientific research (ESR) in expanding the medical and scientific understanding of the Company?s medicines, and in identifying associated areas of unmet need in breast cancer. More than half of the AstraZeneca abstracts at this year?s SABCS are ESR trials with AstraZeneca medicines across various subtypes of breast cancer. Abstracts to be presented at 2020 SABCS featuring AstraZeneca medicines and potential new medicines include:*

*Denotes ESR

AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated?to deliver even more effective treatments to patients in need ? with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines?Faslodex?(fulvestrant) and?Zoladex?(goserelin) and the next-generation SERD and potential new medicine AZD9833. PARP inhibitor,?Lynparza?(olaparib) was the first targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research?Lynparza?in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state. Building on the first approval of?Enhertu,?a HER2-directed antibody-drug conjugate,?in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy durvalumab?in combination with other oncology medicines, including?Lynparza?and?Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan (DS-1062). AstraZeneca in oncology AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of?new medicines that has the potential to transform patients? lives and the Company?s future. With?seven?new medicines launched between 2014 and 2020, and a broad pipeline?of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. By harnessing the power of six scientific platforms ? Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies ? and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment 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, primarily for the treatment of diseases in three therapy areas - Oncology, 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 Twitter?@AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click?here. For Media contacts, click?here.

References 1.?Enhertu?is developed and commercialised in collaboration with Daiichi Sankyo worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. 2.?Lynparza?is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada).