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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
Inavolisib
| NCT ID | Study Phase | Enrollment Status | Study Title | |
|---|---|---|---|---|
| NCT05894239 | Phase III | Recruiting | A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | View details |
| NCT06790693 | Phase III | Recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer | View details |
| NCT07054190 | Phase II | Recruiting | A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer | View details |
| NCT07368998 | Phase II | Recruiting | To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer | View details |
| NCT07287150 | Phase II | Recruiting | A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer | View details |
| NCT07405801 | Phase II | Recruiting | A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer | View details |
| NCT05646862 | Phase III | Active, not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | View details |
| NCT04191499 | Phase II | Active, not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer | View details |
| NCT03424005 | Recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer | View details | |
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.
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mBC
metastatic breast cancer -
PI3K
phosphatidylinositol 3-kinase