AstraZeneca reinforces leadership in breast cancer at SABCS 2021 with new data underscoring ambition to redefine cancer care

3 December 2021 07:00 GMT

(Updated 7 December 2021)

 

Data from DESTINY-Breast03 will reaffirm the efficacy of Enhertu in treating HER2-positive metastatic breast cancer, including patients with stable brain metastases

Extensive portfolio of 14 approved and potential new medicines to be featured across subtypes and stages of disease, including data for novel combinations
 

AstraZeneca will underscore its ambition to redefine care with new data from across its portfolio of innovative medicines at the 2021 San Antonio Breast Cancer Symposium (SABCS) 7-10 December 2021.

Fourteen AstraZeneca medicines and potential new medicines from the pipeline will be featured across 33 abstracts showcasing the Company’s leadership across different types and stages of breast cancer, including three oral presentations.

Breast cancer is now the most diagnosed cancer worldwide with an estimated 2.3 million people diagnosed in 2020.1

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Continuing our year of breakthroughs in breast cancer, our data at SABCS will reinforce the practice-changing potential of Enhertu with new analyses from the DESTINY-Breast03 trial. Early data from the BEGONIA and TROPION-PanTumor01 trials demonstrate great promise in treating patients who have limited treatment options. These data build on our decades of experience in pioneering medicines to redefine care for patients.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Progress in breast cancer increasingly involves more personalised approaches to treating patients across subtypes and stages of disease, which is a key focus of our data at this year’s SABCS. Our extensive knowledge of breast cancer disease biology and the patient experience fuel our ambition to deliver medicines that can truly revolutionise and reshape treatment for every type of breast cancer patient.”

Transforming the treatment of advanced breast cancers with antibody drug conjugates (ADCs)
An oral presentation will share further results from a range of patient subgroups from the DESTINY-Breast03 Phase III trial, including those with stable brain metastases and patients characterised by hormone receptor status, number of prior lines of therapy or status of visceral metastasis.

Results from DESTINY-Breast03 demonstrated superior progression-free survival (PFS) for Enhertu (trastuzumab deruxtecan) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer previously treated with trastuzumab and a taxane.

In another oral presentation, updated results from the TROPION-PanTumor01 Phase I trial will continue to build promising evidence of the anti-tumour activity of datopotamab deruxtecan in patients with triple-negative breast cancer (TNBC).

Treating breast cancer early where there is more opportunity for cure
New data on patient quality of life from the OlympiA Phase III trial of Lynparza (olaparib) will be presented as an oral presentation.

These patient-reported outcomes data will provide compelling evidence that further supports Lynparza as a potential treatment option for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk HER2-negative early breast cancer.

The supplemental New Drug Application of Lynparza for this indication was recently granted Priority Review by the US Food and Drug Administration.

Changing the treatment landscape with next-generation medicines and novel combinations
A poster and spotlight poster discussion will share results from the BEGONIA Phase Ib/II trial testing Imfinzi (durvalumab) combinations in advanced/metastatic TNBC with data from arm 1 (Imfinzi plus paclitaxel), arm 2 (Imfinzi, paclitaxel and capivasertib) and arm 5 (Imfinzi, paclitaxel and oleclumab), which will further demonstrate the benefits of combining immune checkpoint inhibitors with other novel molecules.

Additionally, ongoing trials posters will share information about the ongoing SERENA-4 Phase III trial which evaluates our next-generation oral selective oestrogen receptor degrader (SERD) camizestrant (AZD9833) in combination with CDK4/6 inhibitors in the 1st-line treatment of patients with oestrogen receptor (ER)-positive, HER2-negative advanced breast cancer, and the SERENA-6 Phase III trial of camizestrant with CDK4/6 inhibitors in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer with an ESR1 mutation.

A further ongoing trial poster will share information on the CAPItello-292 Phase III trial, evaluating the benefit of adding capivasertib (an AKT inhibitor) to the treatment regimen of Faslodex (fulvestrant) and palbociclib in patients with HR-positive, HER2-negative locally advanced, unresectable or metastatic breast cancer.

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

Key AstraZeneca presentations during SABCS 2021

Lead author

Abstract title

Presentation details

Enhertu (trastuzumab deruxtecan)

Hurvitz S

Trastuzumab deruxtecan (T-DXd; DS-8201a) vs. trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer (mBC): results of the randomized phase 3 study DESTINY-Breast03

Presentation GS3-01

Oral – General Session 3

9 December, 2021

08:45 – 11:30 CT

14:45 – 17:30 GMT

Vaz Batista M

Trastuzumab deruxtecan in patients with HER2[+] or HER2-low–expressing advanced breast cancer and central nervous system involvement: Preliminary results from the DEBBRAH phase 2 study [IIS]

Publication PD4-06

Spotlight Poster Discussion 4

8 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Datopotamab deruxtecan (Dato-DXd)

Krop I

Datopotamab deruxtecan (Dato-DXd) in Advanced/Metastatic Human Epidermal Growth Factor Receptor 2 Negative (HER2−) Breast Cancer: Results From the Phase 1 TROPION-PanTumor01 Study [J101 TNBC prelim results]

Presentation GS1-05

Oral presentation – General Session 1

7 December, 2021

08:00 – 10:45 CT

14:00 – 16:45 GMT

Lynparza (olaparib)

Ganz PA

Quality of life results from OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)-adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high risk HER-2 negative early breast cancer

Presentation GS4-09

Oral – General Session 4

10 December, 2021

08:45 – 11:15 CT

14:45 – 17:15 GMT

Imfinzi (durvalumab)

Schmid P

BEGONIA: Phase 1b/2 study of durvalumab (d) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC): Results from arm 1 d + paclitaxel (p), arm 2 d + p + capivasertib (c), and arm 5 d + p + oleclumab (o)

Publication PD10-03

Spotlight Poster Discussion 10

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Camizestrant (AZD9833)

André F

SERENA-4: A Phase III comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive/HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease

Publication OT2-11-06

Ongoing Trials Poster Session 2

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Bidard FC

SERENA-6: A Phase III study to assess the efficacy and safety of AZD9833 (camizestrant) compared with aromatase inhibitors when given in combination with palbociclib or abemaciclib in patients with HR+/HER2- metastatic breast cancer with detectable ESR1m who have not experienced disease progression on first-line therapy

Publication OT2-11-05

Ongoing Trials Poster Session 2

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Faslodex (fulvestrant) and capivasertib

Rugo HS

CAPItello-292: A phase Ib/III study of capivasertib, palbociclib and fulvestrant, versus placebo, palbociclib and fulvestrant, for endocrine therapy-resistant HR+/HER2− advanced breast cancer

Publication OT2-14-01

Ongoing Trials Poster Session 2

9 December, 2021

17:00 – 18:30 CT

23:00 – 00:30 (+1) GMT

Notes

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 and Zoladex and the next-generation oral SERD and potential new medicine camizestrant.

PARP inhibitor Lynparza is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD 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.

Building on the first approval of Enhertu, a HER2-directed ADC, 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 Imfinzi in combination with other oncology medicines, including Lynparza and Enhertu, evaluating 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.

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 Twitter @AstraZeneca.

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Reference
1. GLOBOCAN. Breast Cancer. Available at https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf. Accessed December 2021.


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