FDA Clears AstraZeneca Breast Cancer Regimen for Early Detection
核心洞察
The FDA granted accelerated approval to AstraZeneca's ETCAMAH (搜索) (camizestrant) with a CDK4/6 (搜索) inhibitor for HR-positive, HER2 (搜索)-negative advanced breast cancer (搜索) with emerging ESR1 (搜索) mutations.
Approval rests on the Phase III SERENA-6 trial, which used circulating tumor DNA monitoring to detect ESR1 (搜索) mutations before clinical or radiographic progression.
In interim analysis, the combination cut progression or death risk by 56% versus continued aromatase inhibitor therapy, with median progression-free survival of 16 versus 9.2 months.
AstraZeneca has received accelerated U.S. approval for ETCAMAH (搜索) (camizestrant) in combination with a CDK4/6 (搜索) inhibitor for adults with hormone receptor-positive, HER2 (搜索)-negative, locally advanced or metastatic breast cancer (搜索) whose tumors develop an ESR1 (搜索) mutation during first-line treatment with an aromatase inhibitor plus a CDK4/6 inhibitor. The approved CDK4/6 inhibitor partners are abemaciclib, palbociclib or ribociclib. The FDA concurrently approved a companion diagnostic for detecting emerging ESR1 resistance mutations in circulating tumor DNA.
The decision is based on the Phase III SERENA-6 trial, which used circulating tumor DNA monitoring during routine blood testing at tumor scans every two to three months. When an ESR1 (搜索) mutation emerged without disease progression, patients switched from their existing aromatase inhibitor to ETCAMAH (搜索) while continuing the same CDK4/6 (搜索) inhibitor. In a planned interim analysis, the combination reduced the risk of disease progression or death by 56% compared with continued anastrozole or letrozole plus a CDK4/6 inhibitor. Median progression-free survival was 16 months versus 9.2 months. A subsequent planned analysis found median time to second disease progression of 25.7 months versus 19.1 months for the control group. Overall survival data remain immature and will continue to be assessed as a key secondary endpoint.
ESR1 (搜索) mutations are associated with resistance to endocrine therapy, and AstraZeneca reported that about 30% of patients with endocrine-sensitive, HR-positive disease develop them during first-line treatment before disease progression. The safety profile of ETCAMAH (搜索) with each CDK4/6 (搜索) inhibitor was consistent with the known profiles of the individual medicines, with no new safety concerns and low, similar discontinuation rates between groups. ETCAMAH is also approved in more than 30 countries, including the European Union, Japan, Canada and the UK, based on SERENA-6.
Source: MyChesCo