- 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

José 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-naïve 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:*

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