Search
For optimal search results, please limit to 2 product keywords
If you are searching for information related to a product:
- For optimal results, please enter at least 2 search terms in addition to product name
- Example: [product name] [search term] [search term]
- Example: Product + clinical trials
- For an exact match, please include search terms in double quotations. For example: "Elevatum"
Summary
Inavolisib is an inhibitor of phosphatidylinositol 3-kinase (PI3K) with inhibitory activity predominantly against the catalytic alpha subunit p110α (encoded by the PIK3CA gene).
Reference: Itovebi. Prescribing Information. Genentech; 2025. https://www.gene.com/download/pdf/itovebi_prescribing.pdf
Clinical Trials
| PIK3CA-mutated HR+/HER2– metastatic breast cancer (mBC) |
|||
|---|---|---|---|
| Phase | Enrollment Status | Title | |
| Phase III | Active, not recruiting | A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy (INAVO121) | View Details |
| Phase III | Recruiting | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123)1 | View Details |
| PIK3CA-mutated HR+/HER2– Early breast cancer (eBC) |
|||
|---|---|---|---|
| Phase II | Recruiting | A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer (neoTOV) | View Details |
| PIK3CA-mutated HER2+ Metastatic breast cancer (mBC) |
|||
|---|---|---|---|
| Phase | Enrollment Status | Title | |
| Phase III | Recruiting | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) | View Details |
HR=hormone receptor
HER2=human epidermal growth factor receptor 2
Proposed Mechanism of Action
Inavolisib is an inhibitor of phosphatidylinositol 3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα.[1]
In vitro, inavolisib induced the degradation of mutated PI3K catalytic alpha subunit p110α (encoded by the PIK3CA gene), inhibited phosphorylation of the downstream target AKT, reduced cellular proliferation, and induced apoptosis in PIK3CA-mutated breast cancer cell lines.[1]
In vivo, inavolisib reduced tumor growth in PIK3CA-mutated, estrogen receptor-positive, breast cancer xenograft models. The combination of inavolisib with palbociclib and fulvestrant increased tumor growth inhibition compared to each treatment alone or the doublet combinations.[1]
ATP, adenosine triphosphate; ER, oestrogen receptor; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mTOR, mammalian target of rapamycin; PIP2, phosphatidylinositol (4,5)-bisphosphate; PIP3, phosphatidylinositol (3,4,5)-trisphosphate; RTK, receptor tyrosine kinase.
Looking for more information?
Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.
Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT
-
mBC
metastatic breast cancer -
PI3K
phosphatidylinositol 3-kinase