In our January 2023 issue, we discussed biomarkers for which there is not yet enough information to guide treatment decisions. Since then, clinical trials have resulted in new information about new biomarkers that can now be used to select treatments. Below, we provide updates for new biomarkers that are now recommended to guide treatment decisions for MBC. Clinical trials continue to be important to provide new data about possible future use of other biomarkers.
The most recent National Comprehensive Cancer Network (NCCN) guidelines, updated March 23, 2023, recommend elacestrant (Orserdu®) for estrogen receptor-positive (ER+), HER2-negative (HER2-) MBC with a mutation in a gene called ESR1. Mutations in ESR1 can be identified with a Food and Drug Administration (FDA)-approved biomarker test.
In November 2023, the FDA approved capivasertib (Truqap®) for hormone receptor-positive (HR+), HER2- MBC with alterations in PIK3CA, AKT1, and/or PTEN genes. Following this approval, the American Society of Clinical Oncology (ASCO) updated its guidelines to recommend testing for these alterations and treatment with capivasertib. Alterations in these biomarkers (PIK3CA, AKT1, and/or PTEN) can be identified with an FDA-approved biomarker test.
ESR1 Mutations and ER+, HER2- MBC
- US Food and Drug Administration: The FDA approved elacestrant for ER+, HER2-, ESR1-mutated MBC and a companion diagnostic test to identify the biomarker
- American Society of Clinical Oncology: Testing for an ESR1 mutation can be done by examining ctDNA that is present in a liquid biopsy
- National Comprehensive Cancer Network: Elacestrant is recommended for ER+, HER2-, ESR1-mutated MBC
PIK3CA, AKT1, and PTEN Alterations and HR+, HER2- MBC
- US Food and Drug Administration: The FDA approved capivasertib with fulvestrant for HR+, HER2- MBC with alterations in PIK3CA, AKT1, and/or PTEN and a companion diagnostic test to identify the biomarker
- American Society of Clinical Oncology: ASCO updated its guidelines to recommend capivasertib for HR+, HER2- MBC with alterations in PIK3CA, AKT1, and/or PTEN
MBC Clinical Trials
- Metastatic Trial Search: Trials for Elacestrant (Orserdu®)
- Metastatic Trial Search: Trials for Capivasertib (Truqap®)
Last Modified on April 30, 2024