INAVO120
Regimen
- Experimental
- Inavolisib 9 mg daily plus palbociclib 125 mg (3/1) plus fulvestrant 500 mg.
- Control
- Placebo plus palbociclib plus fulvestrant.
Population
Men and women with HR+/HER2- PIK3CA-mutant advanced breast cancer that had progressed on or within 12 months of completing adjuvant endocrine therapy (endocrine-resistant), no prior therapy for advanced disease.
Key finding
INAVO120 established the first PI3K-alpha selective inhibitor triplet (inavolisib + palbociclib + fulvestrant) in 1L PIK3CA-mutant, endocrine-resistant HR+/HER2- metastatic disease. FDA approved October 2024; NCCN v2.2026 BINV-P lists inavolisib/palbociclib/fulvestrant as a preferred option for PIK3CA-mutant tumors.
Source: PMID 39476340
Timeline
- Publication: 2024 Oct 31
Guideline citations
- NCCN BREAST