INAVO120
Trial question
What is the role of inavolisib-based therapy in patients with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
98.0% female
2.0% male
N = 325
325 patients (319 female, 6 male).
Inclusion criteria: patients with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer who had had relapse during or within 12 months after completion of adjuvant endocrine therapy.
Key exclusion criteria: metaplastic breast cancer; history of leptomeningeal disease or carcinomatous meningitis; prior systemic therapy for metastatic breast cancer; prior treatment with fulvestrant or any selective estrogen-receptor degrader; CNS metastases; T2DM requiring ongoing systemic treatment; T1DM.
Interventions
N=161 inavolisib (inavolisib 9 mg PO daily plus palbociclib/fulvestrant).
N=164 placebo (matching placebo plus palbociclib/fulvestrant).
Primary outcome
Median progression-free survival
15 months
7.3 months
15.0 months
11.3 months
7.5 months
3.8 months
0.0 months
Inavolisib
Placebo
Significant
increase ▲
Significant increase in median progression-free survival (15 months vs. 7.3 months; HR 2.33, 95% CI 1.7 to 3.13).
Secondary outcomes
Significant increase in overall survival at 18 months (73.7% vs. 67.5%; HR 1.56, 95% CI 1.03 to 2.33).
Significant increase in objective response (58.4% vs. 25%; AD 33.4%, 95% CI 23.3 to 43.5).
Significant increase in median response duration (18.4 months vs. 9.6 months; HR 1.75, 95% CI 1.01 to 3.03).
Safety outcomes
No significant differences in at least 1 adverse event, grade 3 or 4 neutropenia.
Conclusion
In patients with PIK3CA-mutated, HR+/HER2- locally advanced or metastatic breast cancer who had had relapse during or within 12 months after completion of adjuvant endocrine therapy, inavolisib was superior to placebo with respect to median progression-free survival.
Reference
Nicholas C Turner, Seock-Ah Im, Cristina Saura et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596.
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