Bli medlem
Bli medlem

Du är här

2022-11-22

AstraZeneca aims to redefine breast cancer care with new data across the treatment spectrum at SABCS 2022

Data will show clinical opportunity in HR-positive advanced breast cancer for potential first-in-class AKT inhibitor capivasertib and next-generation oral SERD camizestrant. Enhertu data will reinforce potential to set new standards in HER2-targetable disease. Data for antibody drug conjugate datopotamab deruxtecan will demonstrate potential in HR-positive and triple-negative breast cancer.

AstraZeneca will present new data advancing its ambition to redefine care at the 2022 San Antonio Breast Cancer Symposium (SABCS), 6-10 December 2022.

Twelve AstraZeneca medicines and potential new medicines will be featured in 55 presentations, including five oral presentations, showcasing the Company's growing leadership across different subtypes and stages of breast cancer.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Our data at SABCS are strong validation of our clinical strategy to provide next-generation treatment solutions for patients with nearly all major types of breast cancer. We are excited to share results from the pivotal CAPItello-291 trial, which will support the opportunity of our novel AKT inhibitor capivasertib for patients with HR-positive disease. We also look forward to presenting defining data from the SERENA-2 Phase II trial that will demonstrate the potential of our next-generation SERD camizestrant to improve upon currently available endocrine therapies for patients with ER-driven disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "As we close another year of breakthroughs in breast cancer, our presence at SABCS will showcase the opportunity for our portfolio to shape clinical practice and redefine care across subtypes and stages of this disease. Compelling results for potential new medicines capivasertib and camizestrant as well as new data from antibody drug conjugates Enhertu and datopotamab deruxtecan will underscore our focus on addressing the greatest unmet needs and delivering personalised treatment for more patients with breast cancer."

Aiming to set new standards of care across HER2-positive metastatic breast cancer

Two late-breaking presentations from the DESTINY-Breast clinical programme will highlight the efficacy of Enhertu (trastuzumab deruxtecan) treatment in patients with HER2-positive metastatic breast cancer across lines of therapy.

Updated results from the DESTINY-Breast03 Phase III trial of Enhertu versus trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer previously treated with trastuzumab and a taxane will be presented, including updated progression-free survival (PFS) data and overall survival (OS) results.

In addition, primary results from the DESTINY-Breast02 Phase III trial will be presented, further demonstrating the clinical benefit of Enhertu compared to conventional chemotherapy-based regimens in patients with HER2-positive metastatic breast cancer previously treated with T-DM1.

Data will also be presented from the ROSET-BM retrospective study and DEBBRAH Phase II trial further confirming Enhertu activity in patients with HER2-positive or HER2-low metastatic breast cancer with active or stable brain metastases.

Reshaping treatment expectations in HR-positive advanced breast cancer

A late-breaking presentation will illustrate the Company's focus on addressing endocrine resistance in advanced HR-positive breast cancer.

Detailed data will be shared from the CAPItello-291 Phase III trial of the AKT inhibitor capivasertib in combination with Faslodex (fulvestrant) versus Faslodex alone in endocrine-resistant, HR-positive, HER2-low or negative advanced breast cancer. CAPItello-291 recently met both primary endpoints (https://www.astrazeneca.com/media-centre/press-releases/2022/capivasertib-phase-iii-trial-met-primary-endpoints.html), demonstrating improvement in PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN genes.

Several presentations will establish the clinical potential of the next-generation oral selective oestrogen receptor degrader (SERD) camizestrant as a monotherapy or in combination for patients with oestrogen receptor positive (ER-positive) advanced breast cancer.

  • A late-breaking presentation will highlight detailed results from the positive SERENA-2 Phase II trial (https://www.astrazeneca.com/media-centre/press-releases/2022/camizestrant-significantly-improved-progression-free-survival.html) of camizestrant versus Faslodex in advanced ER-positive breast cancer.
  • Analyses from further cohorts of the SERENA-1 Phase I trial of advanced ER-positive breast cancer will also be presented, which will show the potential to combine camizestrant with abemaciclib, a CDK4/6 inhibitor.
  • A spotlight poster will feature data showing promising preclinical activity with camizestrant in ER-positive breast cancer when used in double and triple combinations with CDK4/6, mTOR, AKT or PI3K inhibitors, in ESR1 wild-type and mutated models.

Additionally, several presentations will showcase AstraZeneca's commitment to transforming the treatment landscape for HR-positive breast cancer with antibody drug conjugates (ADCs) and by identifying new tumour subtypes that may respond to targeted therapies.

  • A poster presentation of results from the TROPION-PanTumor01 Phase I trial will characterise the safety and encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated HR-positive, HER2-negative inoperable or metastatic breast cancer. Datopotamab deruxtecan is also being tested in these patients in earlier lines of treatment in the randomised TROPION-Breast01 Phase III trial.

  • Multiple poster presentations will share results for potential diagnostic tools to better identify and optimise treatment for patients across the spectrum of HER2 expression, including those with HER2-low tumours who may benefit from treatment with Enhertu.

  • Data from various subgroup analyses from the DESTINY-Breast04 Phase III trial will reinforce the clinical meaningfulness of HER2-low as an actionable patient segment in patients with metastatic breast cancer.

Redefining care for triple-negative breast cancer (TNBC)

Two spotlight poster discussions will share results from the BEGONIA Phase Ib/II trial testing Imfinzi (durvalumab) combinations in advanced or metastatic TNBC, showing the potential to drive improved outcomes with the addition of ADCs.

Additionally, updated results from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan monotherapy will show encouraging and durable anti-tumour activity, and a manageable safety profile in heavily pre-treated patients with metastatic TNBC. The TROPION-Breast02 Phase III trial is evaluating datopotamab deruxtecan as 1st-line therapy for patients with metastatic TNBC.

Enhertu and datopotamab deruxtecan are developed and commercialised in collaboration with Daiichi Sankyo worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights.

Key AstraZeneca presentations during SABCS 2022

Lead author Abstract title Presentation details
HER2
-positive
breast
cancer
Krop, I Trastuzumab Presentation #GS2-01
deruxtecan vs
physician's choice Oral Presentation -
in patients with General Session 2
HER2+ unresectable
and/or metastatic 7 December 2022
breast cancer
previously treated 09:00 - 09:15 CT
with trastuzumab
emtansine: primary 15:00 - 15:15 GMT
results of the
randomized phase 3
study DESTINY
-Breast02
Hurvitz, SA Trastuzumab Presentation #GS2-02
deruxtecan versus
trastuzumab Oral Presentation -
emtansine in General Session 2
patients with HER2
-positive metastatic 7 December 2022
breast cancer:
Updated survival 09:15 - 09:30 CT
results of the
randomized, phase 3 15:15 - 15:30 GMT
study DESTINY
-Breast03
Takashi, Y Trastuzumab Presentation #PD7-01
deruxtecan for the
treatment of Spotlight Poster
patients with HER2 Discussion 7
-positive breast
cancer with brain 7 December 2022
and/or
leptomeningeal 17:00 CT
metastases: A
multicenter 23:00 GMT
retrospective study
(ROSET-BM study)
Hamilton, EP Dose-expansion study Presentation #PD18-11
of Trastuzumab
Deruxtecan as Spotlight Poster
monotherapy or Discussion 18
combined with
Pertuzumab in 9 December 2022
patients With
metastatic human 07:00 CT
epidermal growth
factor receptor 2 13:00 GMT
-positive (HER2+)
breast cancer in
DESTINY-Breast07 (DB
-07)
Varghese, D A real-world Presentation #P1-11-19
evidence study of
treatment patterns Poster Session 1
in patients with
HER2-positive 6 December 2022
metastatic breast
cancer who have 17:00 CT
received at least 2
-lines of therapy 23:00 GMT
Lam, C Treatment patterns Presentation #P4-03-34
and outcomes among
patients with HER2 Poster Session 4
-postivemetastatic
breast cancerin the 8 December 2022
United States
07:00 CT

13:00 GMT
Henderson, M Adverse events (AEs) Presentation #P4-07-53
in phase III
clinical trials of Poster Session 4
patients with human
epidermal growth 8 December 2022
factor receptor-2
positive (HER2+) 07:00 CT
breast cancer (BC):
a meta-analysis 13:00 GMT
Lin, NU Open-label, phase Presentation #OT2-16-02
3b/4 study of
trastuzumab Ongoing Trials Poster
deruxtecan (T-DXd) Session 2
in patients with or
without baseline 7 December 2022
brain metastasis
with 17:00 CT
advanced/metastatic
human epidermal 23:00 GMT
growth factor
receptor 2-positive
breast cancer:
DESTINY-Breast12
HER2-low
breast
cancer
Prat, A Determination of Presentation #HER2-18
HER2-low status in
tumors of patients HER2 Low: A Separate
with unresectable Entity Special Poster
and/or metastatic Session 
breast cancer in
DESTINY-Breast04 7 December 2022

09:45 - 11:00 CT

15:45 - 17:00 GMT
Viale, G Retrospective Study Presentation #HER2-15
to Estimate the
Prevalence and HER2 Low: A Separate
Describe the Entity Special Poster
Clinicopathological Session
Characteristics,
Treatment Patterns, 7 December 2022
and Outcomes of HER2
-Low Breast Cancer 09:45 - 11:00 CT

15:45 - 17:00 GMT
Rüschoff, J Proficiency Presentation #HER2-13
assessment of HER2
-low breast cancer HER2 Low: A Separate
scoring with the Entity Special Poster
Ventana PATHWAY 4B5 Session 
and Dako HercepTest
HER2 assays and the 7 December 2022
impact of
pathologist training 09:45 - 11:00 CT

15:45 - 17:00 GMT
Schmid, P Trastuzumab Presentation #PD11-08
deruxtecan (T-DXd) +
durvalumab (D) as Spotlight Poster
first-line (1L) Discussion 11
...

Författare Cision