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A triple combination that doubled progression-free time and, unusually for this disease, extended survival by seven months in a hard-to-treat group.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
325 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Inavolisib + palbociclib + fulvestrant | 161 | 15 months | 0.43 (0.32 to 0.59) | <0.001 | link |
| Placebo + palbociclib + fulvestrant | 164 | 7.3 months | ||||
| Overall survival | Inavolisib arm | - | 34 months | 0.67 (0.48 to 0.94) | 0.02 | link |
| Placebo arm | - | 27 months | ||||
| Objective response rate | Inavolisib arm | - | 62.7% | - | - | link |
| Placebo arm | - | 28% |
A second publication from the INAVO120 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT04191499 with the most citations, so it is the natural first reading for anyone following the INAVO120 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Inavolisib, PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant.
Shares PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant, PIK3CA / PI3K-alpha.
Shares PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant, HR-positive / HER2-negative breast cancer.
Shares Inavolisib, PI3K, AKT and mTOR inhibitors, Fulvestrant, Small-molecule kinase inhibitors.
Shares Inavolisib, PI3K, AKT and mTOR inhibitors, HR-positive / HER2-negative breast cancer, Small-molecule kinase inhibitors.
Shares PI3K, AKT and mTOR inhibitors, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Fulvestrant, PIK3CA / PI3K-alpha.
Shares Inavolisib, PI3K, AKT and mTOR inhibitors, Fulvestrant, Small-molecule kinase inhibitors.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, CDK4/6, Fulvestrant, HR-positive / HER2-negative breast cancer.