Teresa Klinowska, Ph.D. Global Product Leader, Late Stage Oncology at AstraZeneca discussed the SABCS 20 abstract – SERENA-1 Phase I trial show strong efficacy and safety profile for next-generation oral SERD AZD9833 in HR-positive advanced breast cancer
Principal abstracts include:
New results from the Phase II DESTINY-Breast01 trial reinforcing the long-lasting efficacy of ENHERTU® (fam-trastuzumab deruxtecan-nxki) in HER2-positive metastatic breast cancer after two or more previous anti-HER2 regimens
New results from the SERENA-1 Phase I trial, which demonstrated good efficacy and safety in HR-positive, HER2-negative advanced breast cancer, for the next generation oral selective oestrogen receptor degrader (SERD), AZD9833 as monotherapy, and in combination with palbociclib, a CDK4/6 inhibitor,
The revised 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 will be illustrated by new, longer-term data from DESTINY-Breast01 to be presented at SABCS.
In addition, AstraZeneca and Daiichi Sankyo Business, Limited (Daiichi Sankyo) will present multiple TiP abstracts outlining how the companies are building on the promising findings of ENHERTU in HER2-positive metastatic breast cancer patients. These include research to investigate the potential of ENHERTU in earlier treatment lines and disease stages and in new settings for breast cancer, including patients with low HER2 expression levels. Combinations with other anti-cancer pharmaceutical products such as paclitaxel, FASLODEX (fulvestrant), IMFINZI (durvalumab) and the possible new drug capivasertib, an AKT inhibitor, are also included.
For women with HR-positive breast cancer, AstraZeneca will present new efficacy and safety findings from the dose escalation and expansion cohort of SERENA-1, a Phase I clinical trial of next-generation oral SERD AZD9833 as monotherapy and in combination with the CDK4/6 inhibitor palbociclib.
The Company will present two phase II trial-in-progress (TiP) abstracts based on the revised SERENA-1 results for the potential new medicine AZD9833, examining its effectiveness and protection in previously treated postmenopausal women with advanced breast cancer and its biological effects in women with treatment-naïve early-stage breast cancer.
Real-world evidence to consider outcomes for patients with germline BRCA mutations and treatment trends among patients with HER2-positive metastatic breast cancer is also provided by AstraZeneca. Data will also be provided by the Organization on the potential role of artificial intelligence and digital pathology in assessing HER2 expression levels in breast cancer patients.
In addition, AstraZeneca acknowledges that externally funded scientific research (ESR) plays an important role in extending the Company’s medical and scientific knowledge of medicines and discovering related areas of unmet need for breast cancer. ESR trials with AstraZeneca medicines across multiple subtypes of breast cancer are more than half of the AstraZeneca abstracts at this year’s SABCS.