# INAVO120

Source: https://onco.cc/trials/inavo120/  
OnCo record `inavo120` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A triple combination that doubled progression-free time and, unusually for this disease, extended survival by seven months in a hard-to-treat group.

## Summary

INAVO120, trial NCT04191499 sponsored by Roche and Genentech and reported in 2023, tested a triple combination that doubled progression-free time and, unusually for this disease, extended overall survival in first-line PIK3CA-mutant HR-positive, HER2-negative advanced breast cancer relapsing on or after adjuvant endocrine therapy. It randomised 325 women to inavolisib or placebo with palbociclib and fulvestrant, met its primary progression-free survival endpoint with a large effect, showed a significant survival benefit at the final analysis and a much higher response rate, and led to approval in October 2024; inavolisib degrades mutant p110-alpha, giving less hyperglycaemia than alpelisib. INAVO121 and INAVO122 are ongoing, and whether the benefit extends to later lines is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04191499
- Phase: 2/3
- Setting: First-line PIK3CA-mutant HR+/HER2- advanced breast cancer relapsing on/after adjuvant endocrine therapy: inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant
- Sponsor: Roche / Genentech
- Enrolled: 325
- Result: PFS 15.0 vs 7.3 months, HR 0.43; OS 34.0 vs 27.0 months, HR 0.67.
- Outcomes: Progression-free survival: Inavolisib + palbociclib + fulvestrant 15 months vs Placebo + palbociclib + fulvestrant 7.3 months, HR 0.43; Overall survival: Inavolisib arm 34 months vs Placebo arm 27 months, HR 0.67; Objective response rate: Inavolisib arm 62.7% vs Placebo arm 28%
- Replication: Single pivotal trial; INAVO121 (vs alpelisib) and INAVO122 (HER2+) ongoing.

## Sources

- ClinicalTrials.gov NCT04191499: https://clinicaltrials.gov/study/NCT04191499
- NEJM OS analysis: https://www.nejm.org/doi/abs/10.1056/NEJMoa2501796

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- technologies: [PI3K, AKT and mTOR inhibitors](https://onco.cc/technologies/pi3k-akt-mtor-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- drugs: [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Inavolisib](https://onco.cc/drugs/inavolisib/), [Palbociclib](https://onco.cc/drugs/palbociclib/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- people: [Komal Jhaveri](https://onco.cc/people/komal-jhaveri/)
- key papers: [Inavolisib-Based Therapy in PIK3CA -Mutated Advanced Breast Cancer](https://onco.cc/key-papers/paper-inavo120-n-engl-j-med-2024/), [Overall Survival with Inavolisib in PIK3CA -Mutated Advanced Breast Cancer](https://onco.cc/key-papers/paper-inavo120-n-engl-j-med-2025-update/)

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