AstraZeneca Submits New Drug Application for Next-Generation Oral Selective Estrogen Receptor Degrader AZD9833

Recently, AstraZeneca’s clinical trial application for the new drug AZD9833 was accepted by the Center for Drug Evaluation (CDE), with the intended use of treating ER+ HER2- advanced breast cancer (ABC).

AZD9833 is a next-generation oral selective estrogen receptor alpha (ERα) antagonist and degrader (SERD). It not only inhibits ERα-driven tumor cell growth but also induces the degradation of the ERα receptor.

The Phase I clinical study, codenamed SERENA-1, evaluated the tolerability and efficacy of AZD9833 in premenopausal and postmenopausal patients with ER+ HER2- advanced breast cancer who had received ≥1 prior endocrine therapy and ≤2 prior chemotherapy regimens. After 24 weeks, the overall objective response rate (ORR) was 16.3%, and the clinical benefit rate (CBR) was 42.3%.

Adverse reactions with an incidence ≥10% include: visual disturbances (53%, G3: 3%), bradycardia or sinus bradycardia (45%), nausea (18%), fatigue (13%), dizziness (10%, G3: 17%), vomiting (10%, G3: 17%), and asthenia (10%).

Fulvestrant is the only approved Erα selective degrader, but its intramuscular injection administration limits clinical application. The launch of the oral formulation of AZD9833 will significantly improve patient compliance.

Source: PharmCube Info