AstraZeneca's Class 1 New Drug AZD9833 Granted Clinical Trial Approval in China for Breast Cancer Treatment

Source: Medical Insights

Latest Public Notice from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration: AstraZeneca’s Class 1 New Drug AZD9833 Receives Implicit Approval for Three Clinical Trials, Intended for the Treatment of Breast Cancer. Publicly available information indicates that AZD9833 is an investigational oral selective estrogen receptor degrader (SERD) that has entered Phase 3 clinical development outside of China.

Screenshot source: CDE official website

According to the latest cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, there were 2.26 million new cases of breast cancer globally in 2020, surpassing lung cancer (2.21 million cases) for the first time to become the most common cancer worldwide. Among these, hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer accounts for approximately 70% of all breast cancer cases. Although many different types of therapies for breast cancer have been approved, there remains a significant unmet clinical need among patients.

AZD9833, developed by AstraZeneca, is a next-generation oral estrogen receptor degrader. According to a recent review published in Nature Reviews Drug Discovery, estrogen receptor degraders are among the important late-stage investigational therapies in the field of breast cancer. As small molecules, estrogen receptor degraders bind to estrogen receptors (ER) on the surface of cancer cells, reducing the stability of these receptors and inducing their degradation via the cell’s normal protein degradation machinery. This lowers estrogen receptor levels, thereby inhibiting cancer cell growth. Unlike modulators that suppress estrogen activity, estrogen receptor degraders theoretically provide more comprehensive inhibition of estrogen receptor function by mediating receptor degradation, and may overcome resistance caused by estrogen receptor mutations.

Information on the ClinicalTrials.gov website indicates that AstraZeneca is currently conducting multiple clinical trials of AZD9833 in patients with breast cancer, including a randomized, multicenter, double-blind Phase 3 trial designed to evaluate the efficacy of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) for the treatment of previously untreated ER+/HER2- advanced breast cancer. According to information on the CDE website, this marks the first approval of AZD9833 for clinical development in China.

At the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, researchers presented results from a Phase 1 dose-escalation and expansion study of AZD9833 in the treatment of ER+/HER2- advanced breast cancer. As of January 20, 2020, a total of 60 patients who had previously received treatments such as fulvestrant and CDK4/6 inhibitors were treated with AZD9833. The data showed that AZD9833 demonstrated favorable efficacy and dose-dependent safety; clinical benefit was observed in female patients with ER+ advanced breast cancer across all dose levels.

Statistics show that the number of new breast cancer cases in China reached approximately 420,000 in 2020, making it one of the countries and regions with a higher incidence of breast cancer. We look forward to the smooth progress of clinical studies on AstraZeneca’s oral estrogen receptor degrader, AZD9833, in China, bringing new treatment options for breast cancer patients.

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