Conexiant’s news site is now MDSpire News. Learn more
Advertisement
FDA approves combo for ESR1-mutated breast cancer
In an exploratory subgroup analysis of patients with ESR1-mutated tumors, median progression-free survival was 11.1 months with the combination and 5.5 months with imlunestrant alone.
Clinical Report: FDA approves combo for ESR1-mutated breast cancer
Overview
The FDA has approved imlunestrant in combination with abemaciclib for adults with ESR1-mutated advanced or metastatic breast cancer. This approval is based on the EMBER-3 trial, which evaluated the efficacy of the combination therapy.
Background
The approval of imlunestrant with abemaciclib addresses a need for treatment options in patients with estrogen receptor-positive, HER2-negative breast cancer who have disease progression after endocrine therapy. ESR1 mutations are recognized as a factor in treatment resistance.
Data Highlights
Study
Population
Median PFS (months)
Objective Response Rate (%)
EMBER-3
Overall Population
Not statistically significant for imlunestrant monotherapy vs endocrine therapy
N/A
EMBER-3
ESR1-mutated tumors
11.1 (imlunestrant + abemaciclib) vs 5.5 (imlunestrant alone)
35 (imlunestrant + abemaciclib) vs 15 (imlunestrant alone)
Key Findings
The FDA approved imlunestrant with abemaciclib for ESR1-mutated advanced breast cancer.
The approval was based on the EMBER-3 trial involving 874 adults.
Median progression-free survival was reported as 11.1 months for the combination therapy in patients with ESR1 mutations.
The objective response rates were 35% for the combination therapy versus 15% for imlunestrant alone.
Guardant360 CDx assay was authorized as a companion diagnostic for detecting ESR1 mutations.
Clinical Implications
The use of the Guardant360 CDx assay can aid in identifying patients for this targeted therapy.
Conclusion
The approval of imlunestrant with abemaciclib is a new option for treating ESR1-mutated breast cancer.
A 59-year-old woman was referred to Nicole Gaulin, MD, a gynecologic oncologist at Roswell Park Comprehensive Cancer Center, after learning she had a BRCA2 mutation linked with both breast cancer in a cousin and colon cancer in her father.
Analysis of England’s multicancer early detection screening trial found modest, temporary diagnostic delays in participating regions, adding to concerns about health system effects and the evidence base for population-level blood-based cancer screening.
