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INAVO120

Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer

Phase 3N = 325NCT04191499

Population
PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer with relapse during or within 12 months after completing adjuvant endocrine therapy
Design
Double-blind, randomized trial of first-line inavolisib 9 mg once daily plus palbociclib-fulvestrant versus placebo plus palbociclib-fulvestrant
Primary endpoint
PFS
Arms
  • Inavolisib plus palbociclib-fulvestrant (experimental, n = 161): Inavolisib 9 mg once daily plus palbociclib and fulvestrant
  • Placebo plus palbociclib-fulvestrant (control, n = 164): Placebo plus palbociclib and fulvestrant
People
Turner NC
PFSHR 0.43 (95% CI 0.32–0.59)Δ median PFS+7.7 monthsOSHR 0.67 (95% CI 0.48–0.94)Δ median OS+7 months
Show the numbers
Results reported for INAVO120
EndpointAnalysisInavolisib plus palbociclib-fulvestrantPlacebo plus palbociclib-fulvestrantEffect
PFSprimaryTurner 2024median 15 months (11.3–20.5)median 7.3 months (5.6–9.3)HR 0.43 (95% CI 0.32–0.59)P<0.001Investigator-assessed. Median follow-up 21.3 months (inavolisib) and 21.5 months (placebo); objective response 58.4% vs 25.0%.
OSfinalJhaveri 2025median 34 months (28.4–44.8)median 27 months (22.8–38.7)HR 0.67 (95% CI 0.48–0.94)P=0.02Final OS analysis; median follow-up 34.2 months (inavolisib) and 32.3 months (placebo).
Results reported for INAVO120
EndpointAnalysisInavolisib plus palbociclib-fulvestrantPlacebo plus palbociclib-fulvestrantEffect
PFSprimaryTurner 2024median 15 months (11.3–20.5)median 7.3 months (5.6–9.3)HR 0.43 (95% CI 0.32–0.59)P<0.001Investigator-assessed. Median follow-up 21.3 months (inavolisib) and 21.5 months (placebo); objective response 58.4% vs 25.0%.
OSfinalJhaveri 2025median 34 months (28.4–44.8)median 27 months (22.8–38.7)HR 0.67 (95% CI 0.48–0.94)P=0.02Final OS analysis; median follow-up 34.2 months (inavolisib) and 32.3 months (placebo).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.430.32–0.59
OS0.670.48–0.94
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Inavolisib plus palbociclib-fulvestrant (experimental)
  • Placebo plus palbociclib-fulvestrant (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsInavolisib plus palbociclib-fulvestrantPlacebo plus palbociclib-fulvestrant
0100.0%100.0%
966.0%42.5%
1941.6%16.5%
2827.4%7.0%
3817.3%2.7%
Illustrative — modelled from reported values, not trial data. OS, final.
0%25%50%75%100%020406080Months (modelled)
  • Inavolisib plus palbociclib-fulvestrant (experimental)
  • Placebo plus palbociclib-fulvestrant (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsInavolisib plus palbociclib-fulvestrantPlacebo plus palbociclib-fulvestrant
0100.0%100.0%
2165.2%58.3%
4341.6%33.2%
6427.1%19.3%
8517.7%11.3%
Primary publication: Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024;391(17):1584-1596. PubMedDOI

Appears in

Sources

  1. Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024;391(17):1584-1596.

    PubMedDOI

  2. Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, et al. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025;393(2):151-161.

    PubMedDOI