Study
| Phase 3, double-blind, randomized trial (INAVO120) |
| PIK3CA-mutated, HR+/HER2− locally advanced or metastatic breast cancer relapsed during or within 12 mos after adjuvant endocrine therapy |
| Inavolisib + palbociclib + fulvestrant vs. placebo + palbociclib + fulvestrant |
Efficacy
| ORR: 62.7% vs. 28.0% (p<0.001) |
| mDoR: 19.2 mos vs. 11.1 mos |
| mPFS: 17.2 mos vs. 7.3 mos (HR: 0.42 [0.32–0.55]) |
| mOS: 34.0 mos vs. 27.0 mos (HR: 0.67 [0.48–0.94]) |
| 2-yr OS: 65.8% vs. 56.3% |
Safety
| Grade ≥3 AEs: Neutropenia (82.6% vs. 80.4%), thrombocytopenia (13.7% vs. 4.9%), anemia (6.8% vs. 1.8%), hyperglycemia (6.8% vs. 0%), stomatitis (5.6% vs. 0%), diarrhea (3.7% vs. 0%) |
| Serious AEs: 27.3% vs. 13.5% |
| Discontinuation due to AEs: 6.8% vs. 0.6% |
N Engl J Med. Published May 31, 2025
Jhaveri KL,Im SA,Saura C Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer
http://doi.org/10.1056/NEJMoa2501796
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
