Olubukola Ayodele/LinkedIn
Jun 1, 2025, 15:32
Olubukola Ayodele on INAVO120 Inavolisib Combo Results at ASCO 2025
Olubukola Ayodele, Consultant Medical Oncologist at the University Hospitals of Leicester NHS Trust, posted on LinkedIn:
“Today at ASCO 2025 (Day 2), the final overall survival results from the INAVO120 trial were presented and simultaneously published in the New England Journal of Medicine.
This phase III study evaluated inavolisib, a potent oral PI3Kα inhibitor, in combination with palbociclib and fulvestrant, compared to standard palbociclib + fulvestrant, in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer.
Key Findings:
– Median OS: 46.7 months (inavolisib arm) vs 39.3 months (control)
HR 0.75: a 25% reduction in the risk of death– Median PFS: 15.0 months vs 11.2 months. HR 0.75
– Time to Chemotherapy: Median of 36.1 months vs 25.9 months. That’s nearly a full year longer before needing chemotherapy, which truly matters at the bedside.
– Patient population: Over 80% had visceral disease. This was a group with significant disease burden. These are the patients who need rescue early.
– Safety: Grade ≥3 neutropenia (52%), hyperglycemia (10%), rash (8%). Discontinuation due to side effects in 13.4%
What does this mean in clinic?
As a breast oncologist, I see many younger women who progress quickly after adjuvant endocrine therapy and CDK4/6 inhibitors. They often present with visceral, life-threatening disease and we need options that act fast and buy time.
Inavolisib shows us we can delay disease progression, defer chemotherapy, and perhaps most importantly, extend survival in a targeted, biomarker-driven way.
But it’s not without trade-offs. These drugs require careful management of toxicities, especially neutropenia and hyperglycaemia. Patients with diabetes were excluded which is not reflective of the real world. A multidisciplinary approach is critical to support these patients.
Still, INAVO120 offers a hopeful path forward. For a population underserved by existing endocrine strategies, this may be the beginning of a new standard.”
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