AstraZeneca demonstrates growing leadership in breast cancer at SABCS with data from its innovative medicines and robust pipeline
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:*
| Abstract title | Lead author | Abstract details |
| Enhertu (trastuzumab deruxtecan)1 | ||
| Updated results from DESTINY-Breast01, a phase 2 trial of trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer | Modi S | PD3-06Spotlight Poster-Discussion 3 – Advances in HER2 Positive DiseaseDate: Wednesday, December 9, 2020Time: 6:30-7:45pm CT |
| Trastuzumab deruxtecan (T-DXd; DS-8201) with nivolumab in patients with HER2-expressing, advanced breast cancer: a 2-part, phase 1b, multicenter, open-label study | Hamilton E | PD3-07 Spotlight Poster-Discussion 3 – Advances in HER2 Positive Disease;Date: Wednesday, December 9, 2020Time: 6:30-7:45pm CT |
| Novel approach to HER2 quantification: digital pathology coupled with AI-based image and data analysis delivers objective and quantitative HER2 expression analysis for enrichment of responders to trastuzumab deruxtecan (T-DXd; DS-8201), specifically in HER2-low patients | Gustavson M | PD6-01Spotlight Poster-Discussion 6 - Novel Approaches to Pathology and ImagingDate: Thursday, December 10, 2020Time: 3:30-4:45pm CT |
| A real-world evidence study of treatment patterns among patients with HER2-positive metastatic breast cancer | Collins J | PS7-82Poster Session 7 - Epidemiology Date: Wednesday, December 9, 2020Time: 8:00am CT |
| Solti-1804 HER2-PREDICT: A biomarker research study of DS8201-A-U301 -U302 and -U303 Trials [TiP]* | Prat A | OT-03-07Ongoing Trials Posters - Antibody-drug ConjugatesDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Trastuzumab deruxtecan (T-DXd; DS-8201) vs trastuzumab emtansine (T-DM1) in high-risk patients with HER2-positive, residual, invasive early breast cancer after neoadjuvant therapy: A randomized, phase 3 trial (DESTINY-Breast05) [TiP] | Geyer Jr CE | OT-03-01Ongoing Trials Posters – Antibody-drug ConjugatesDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Trastuzumab deruxtecan (T-DXd; DS-8201) vs investigator’s choice of chemotherapy in patients with hormone receptor–positive (HR+), HER2 low metastatic breast cancer whose disease has progressed on endocrine therapy in the metastatic setting: A randomized, global phase 3 trial (DESTINYBreast06) [TiP] | Bardia A | OT-03-09Ongoing Trials Posters - Antibody-drug ConjugatesDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Trastuzumab deruxtecan (T-DXd; DS-8201) combinations in patients with HER2-positive advanced or metastatic breast cancer: a phase 1b/2 open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast07) [TiP] | Andre F | OT-03-04Ongoing Trials Posters - Antibody-drug ConjugatesDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Trastuzumab deruxtecan (T-DXd; DS-8201) in combination with other anticancer agents in patients with HER2-low metastatic breast cancer: a phase 1b, open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast08) [TiP] | Jhaveri K | OT-03-05Ongoing Trials Posters - Antibody-drug ConjugatesDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Lynparza (olaparib)2 | ||
| Real-world clinical outcomes of patients with BRCA-mutated (BRCAm) HER2-negative metastatic breast cancer: A CancerLinQ® study | Miller RS | PS7-66Poster Session 7 - Epidemiology Date: Wednesday, December 9, 2020Time: 8:00am CT |
| DOLAF- An international multicenter phase II trial of durvalumab (MEDI4736) plus OLAparib plus Fulvestrant in metastatic or locally advanced ER-positive, HER2-negative breast cancer patients selected using criteria that predict sensitivity to olaparib* | Guiu S | OT-13-05Ongoing Trials Posters - ImmunotherapyDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Ceralasertib (cer) in combination with olaparib (ola) in patients (pts) with advanced breast cancer (BC): Results of Phase I expansion cohorts | Dean E | PS11-18Poster Session 11 – Systemic Therapies II – NewDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Faslodex (fulvestrant) | ||
| Validation of a predictive model for potential response to neoadjuvant endocrine therapy (NET) in postmenopausal women with clinical stage II or III Estrogen Receptor positive (ER+) and HER2 negative (HER2-) breast cancer (BC): An ALTERNATE trial analysis. (Alliance A011106)* | Ellis MJ | PD2-10Spotlight Poster Discussion 2 – Refining Targeted Therapy in HR+ DiseaseDate: Wednesday, December 9, 2020Time: 5:15-6:30pm CT |
| Neoadjuvant chemotherapy (NCT) response in postmenopausal women with clinical stage II or III estrogen receptor (ER+) positive and HER2 negative (HER2-)breast cancer (BC) resistant to endocrine therapy (ET) in the ALTERNATE trial (Alliance A011106)* | Ma CX | GS4-05General Session 4 Date: Friday, December 11, 2020Time: 9:45-10:00am ET |
| Palbociclib (P) in combination with fulvestrant (F) or letrozole (L) in endocrine-sensitive patients (pts) with hormone receptor (HR)[+]/HER2[-] metastatic breast cancer (MBC): detailed safety analysis from a multicenter, randomized, open-label, phase II trial (PARSIFAL)* | Perez-Garcia JM | PS10-17Poster Session 10 – Systemic Therapies I – TargetedDate: Wednesday, December 9, 2020 Time: 8:00am CT |
| Serum thymidine kinase activity in patients with luminal metastatic breast cancer treated with palbociclib and fulvestrant within the PYTHIA trial* | Malorni L | PS5-05Poster Session 5 – Response Prediction Biomarkers IIDate: Wednesday, December 9, 2020Time: 8:00am CT |
| GEICAM/2014-03 (Registem): A prospective registry of unresectable locally advanced or metastatic breast cancer: Characteristics of a subset of patients with triple negative subtype* | Jara C | PS7-25Poster Session 7 EpidemiologyDate: Wednesday, December 9, 2020Time: 8:00 AM CT |
| Evaluating serum thymidine kinase in hormone receptor positive metastatic breast cancer patients receiving first line endocrine therapy in the SWOG S0226 trial* | Paoletti I | PS2-04Poster Session 2 – Markers, PathologyDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Characteristics of HR+/HER2- patients with recurrent disease by HER2 expression from a prospective registry of unresectable locally advanced or metastatic breast cancer: GEICAM/2014-03 (RegistEM)* | Alvarez I | PS7-24Poster Session 7 - Epidemiology Date: Wednesday, December 9, 2020Time: 8:00am CT |
| GEICAM/2014-03 (Registem): A prospective registry of advanced breast cancer: a subset of triple negative breast cancer patients with her2 low expression* | Jara C | PS7-35Poster Session 7 - Epidemiology Date: Wednesday, December 9, 2020Time: 8:00am CT |
| Characteristics of HR+/HER2- patients with recurrent disease from a prospective registry of unresectable locally advanced or metastatic breast cancer: GEICAM/2014-03 (RegistEM)* | Alvarez I | PS7-08Poster Session 7 –Epidemiology Date: Wednesday, December 9, 2020Time: 8:00am CT |
| Assessment of early ctDNA dynamics to predict efficacy of targeted therapies in metastatic breast cancer: Results from plasmaMATCH trial* | Pascual J | PS5-02Poster Session 5 – Response Prediction Biomarkers IIDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Plk1 expression & efficacy of palbociclib in advanced hormonal receptor-positive breast cancer patients from PEARL study (GEICAM/2012-03)* | Guerro-Zotano A | PS2-01Poster Session 2 – Markers, PathologyDate: Wednesday, December 9, 2020Time: 8:00am |
| Mutational profile from circulating tumor DNA in triple negative breast cancer: results from the prospective registry of unresectable locally advanced or metastatic breast cancer GEICAM/2014-03 (RegistEM)* | Guerro-Zotano A | PS5-22Poster Session 5 – Response Prediction Biomarkers IIDate: Wednesday, December 9, 2020Time: 8:00am CT |
| Targetable ERBB2 mutation status is an independent marker of adverse prognosis in estrogen receptor positive, ERBB2 non-amplified primary lobular breast carcinoma: Validation using a novel gene signature of HER2 activation | Alsaleem M | PS6-11Poster Session 6 – Prognostic FactorsDate: Wednesday, December 9, 2020Time: 8:00am CT |
| AZD9833 | ||
| Updated data from SERENA-1: A phase 1 dose escalation and expansion study of the next generation oral SERD AZD9833 as a monotherapy and in combination with palbociclib, in women with ER-positive, HER2-negative advanced breast cancer | Baird R | PS11-05Poster Session 11 – Systemic Therapies II – NewDate: Wednesday, December 9, 2020Time: 8:00am CT |
| A randomised, open-label, parallel-group, multicentre phase 2 study comparing the efficacy and safety of oral AZD9833 versus fulvestrant in women with advanced ER-positive HER2-negative breast cancer (SERENA-2) [TiP] | Oliveria M | OT-09-02Ongoing Trials Posters – Endocrine TherapyDate: Wednesday, December 9, 2020Time: 8:00am CT |
| A randomised, pre-surgical study to investigate the biological effects of AZD9833 doses in women with ER-positive HER2-negative primary breast cancer (SERENA-3) [TiP] | Robertson J F R | OT-09-05Ongoing Trials Posters – Endocrine TherapyDate: Wednesday, December 9, 2020Time: 8:00am CT |
*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.
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References
- Enhertu is 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).