Drug updated on 3/28/2025
| Dosage Form | Tablets (oral; 3 mg,9 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy
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Summary
- This summary is based on the review of one randomized controlled trial. [1]
- In patients with Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA)-mutated, Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative locally advanced or metastatic breast cancer and measurable disease, confirmed Objective Response Rates (ORRs) were 52.0% in the inavolisib + palbociclib + letrozole (Inavo + Palbo + Letro) arm and 40.0% in the inavolisib + palbociclib + fulvestrant (Inavo + Palbo + Fulv) arm.
- Median Progression-Free Survival (PFS) was 23.3 months in the Inavo + Palbo + Letro arm and 35.0 months in the Inavo + Palbo + Fulv arm, in the same patient population.
- Treatment-Related Adverse Events (TRAEs) occurred in all patients; grade ≥3 TRAE rates were 87.9% in the Inavo + Palbo + Letro arm and 85.0% in the Inavo + Palbo + Fulv arm, with discontinuation due to TRAEs reported in 6.1% and 10.0% of patients, respectively. Common TRAEs included stomatitis, hyperglycemia, and diarrhea.
- No pharmacokinetic (PK) drug-drug interactions were observed among the study treatments when administered.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Itovebi (inavolisib) Prescribing Information. | 2025 | Genentech USA, Inc., South San Francisco, CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer | 53Subjects F: 100% M: 0% | 2024 | JournalofClinicalOncology |
Sex Distribution:
F:100%
M:0%
53Subjects
Year:
2024
Source: JournalofClinicalOncology
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Expert consensus on the clinical application of PI3K/AKT/mTOR inhibitors in the treatment of advanced breast cancer | 2022 | Cancer Innovation |