INAVO120
A triple combination that doubled progression-free time and, unusually for this disease, extended survival by seven months in a hard-to-treat group.
PFS 15.0 vs 7.3 months (HR 0.43; updated HR 0.42). Final OS 34.0 vs 27.0 months (HR 0.67, P=0.02) at 34.2 months follow-up; ORR 62.7% vs 28.0%. Inavolisib degrades mutant p110α, giving less hyperglycaemia than alpelisib. Approved October 2024.
Setting
First-line PIK3CA-mutant HR+/HER2- advanced breast cancer relapsing on/after adjuvant endocrine therapy: inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant
Phase
Phase 3
Sponsor
Roche / Genentech
Registry
Headline result
PFS 15.0 vs 7.3 months, HR 0.43; OS 34.0 vs 27.0 months, HR 0.67.
Reported
2023
Enrolled
325
Replication
Single pivotal trial; INAVO121 (vs alpelisib) and INAVO122 (HER2+) ongoing.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 15 vs 7.3 months with Inavolisib + palbociclib + fulvestrant compared with Placebo + palbociclib + fulvestrant; about 7.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 57 percent lower chance of the event at any given time (hazard ratio 0.43, likely range 0.32 to 0.59).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
- Median 34 vs 27 months with Inavolisib arm compared with Placebo arm; about 7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.48 to 0.94).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Objective response rateresponse endpoint
- 62.7 vs 28 out of 100 had their tumour shrink with Inavolisib arm compared with Placebo arm; 34.7 more per 100.
- Roughly one extra person helped for every 3 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Be careful
- These results apply to the people the trial enrolled: First-line PIK3CA-mutant HR+/HER2- advanced breast cancer relapsing on/after adjuvant endocrine therapy: inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PIK3CA); the result should not be assumed for people whose cancer does not have it.
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 participants enrolled.
Progression-free survivalprimary
HR 0.43 (0.32–0.59) · p <0.001
Inavolisib + palbociclib + fulvestrant
15 mo
Placebo + palbociclib + fulvestrant
7.3 mo
Objective response rate
Inavolisib arm62.7 of 100
Placebo arm28 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Inavolisib + palbociclib + fulvestrant | 161 | 15 months | 0.43 (0.32–0.59) | <0.001 | link |
| Placebo + palbociclib + fulvestrant | 164 | 7.3 months | ||||
| Overall survival | Inavolisib arm | — | 34 months | 0.67 (0.48–0.94) | 0.02 | link |
| Placebo arm | — | 27 months | ||||
| Objective response rate | Inavolisib arm | — | 62.7% | — | — | — |
| Placebo arm | — | 28% |
Replication
Single pivotal trial; INAVO121 (vs alpelisib) and INAVO122 (HER2+) ongoing.