Therapy Detail
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| Therapy Name | Inavolisib |
| Synonyms | |
| Therapy Description |
Itovebi (inavolisib) inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (PMID: 36455032). Itovebi (inavolisib) in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) is FDA-approved for use in patients with endocrine-resistant, hormone receptor (HR)-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer harboring PIK3CA mutations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Inavolisib | Itovebi | GDC-0077|RO7113755|RG6114|GDC0077|GDC 0077 | PIK3CA inhibitor 24 | Itovebi (inavolisib) inhibits PIK3CA, with selectivity for mutant PIK3CA over wild-type PIK3CA, potentially resulting in increased apoptosis and decreased growth of PIK3CA-mutant tumors (PMID: 36455032). Itovebi (inavolisib) in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) is FDA-approved for use in patients with endocrine-resistant, hormone receptor (HR)-positive, ERBB2 (HER2)-negative, locally advanced or metastatic breast cancer harboring PIK3CA mutations (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA E545K PIK3CA Q859H | breast cancer | resistant | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, a breast cancer cell line harboring PIK3CA E545K and expressing PIK3CA Q859H was resistant to Itovebi (inavolisib) in culture (PMID: 37916958). | 37916958 |
| PIK3CA I817F PIK3CA H1047R | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) decreased viability of a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA I817F in culture (PMID: 37916958). | 37916958 |
| PIK3CA E453Q PIK3CA H1047R | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E453Q and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by Itovebi (inavolisib) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA Q859K PIK3CA H1047R | breast cancer | resistant | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA Q859K was resistant to Itovebi (inavolisib) in culture (PMID: 37916958). | 37916958 |
| PIK3CA E545K PIK3CA W780R | breast cancer | resistant | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, a breast cancer cell line harboring PIK3CA E545K and expressing PIK3CA W780R was resistant to Itovebi (inavolisib) in culture (PMID: 37916958). | 37916958 |
| PIK3CA H1047R | colon cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) treatment led to decreased cell viability in a colon cancer cell line expressing PIK3CA H1047R in culture (PMID: 34544753). | 34544753 |
| PIK3CA Q859H PIK3CA H1047R | breast cancer | resistant | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA Q859H was resistant to Itovebi (inavolisib) in culture (PMID: 37916958). | 37916958 |
| PIK3CA W780R PIK3CA H1047R | breast cancer | resistant | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA W780R was resistant to Itovebi (inavolisib) in culture (PMID: 37916958). | 37916958 |
| PIK3CA mutant | breast cancer | predicted - sensitive | Inavolisib | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) inhibited proliferation and induced apoptosis in PIK3CA-mutant breast cancer cell lines in culture, and induced apoptosis and tumor regression in PIK3CA-mutant breast cancer cell line and patient-derived xenograft models (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 156). | detail... |
| PIK3CA E545K PIK3CA E726K | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA E726K in cis demonstrated increased sensitivity to growth inhibition by Itovebi (inavolisib) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA E545K PIK3CA E726K | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) decreased viability of a breast cancer cell line harboring PIK3CA E545K and expressing PIK3CA E726K in culture (PMID: 37916958). | 37916958 |
| PIK3CA E545K PIK3CA M1043L | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E545K and PIK3CA M1043L in cis demonstrated increased sensitivity to growth inhibition by Itovebi (inavolisib) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA E545K PIK3CA I817F | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) decreased viability of a breast cancer cell line harboring PIK3CA E545K and expressing PIK3CA I817F in culture (PMID: 37916958). | 37916958 |
| FGFR2 T319I PIK3CA N345K PIK3CA E453K | Her2-receptor negative breast cancer | predicted - resistant | Inavolisib | Case Reports/Case Series | Actionable | In a clinical case study, FGFR2 T319I was identified in circulating tumor DNA at the time of progression on Itovebi (inavolisib) in a patient with ESR1-positive, ERBB2 (HER2)-negative breast cancer harboring PIK3CA N345K and E453K (PMID: 37916958). | 37916958 |
| PIK3CA E545K | breast cancer | sensitive | Inavolisib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Itovebi (inavolisib) treatment led to tumor regression in an ESR1 (ER)-positive breast cancer cell line xenograft model harboring PIK3CA E545K (PMID: 34544753). | 34544753 |
| PIK3CA E545K | colon cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) treatment led to decreased cell viability in a colon cancer cell line expressing PIK3CA E545K in culture (PMID: 34544753). | 34544753 |
| PIK3CA E726K PIK3CA H1047R | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, breast epithelial cells expressing PIK3CA E726K and PIK3CA H1047R in cis demonstrated increased sensitivity to growth inhibition by Itovebi (inavolisib) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA E726K PIK3CA H1047R | breast cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Itovebi (inavolisib) decreased viability of a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA E726K in culture (PMID: 37916958). | 37916958 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05332561 | Phase II | Olaparib Ipatasertib Sacituzumab govitecan-hziy Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab | Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) | Recruiting | DEU | 0 |
| NCT03006172 | Phase I | Inavolisib + Letrozole + Palbociclib Inavolisib Fulvestrant + Inavolisib Inavolisib + Letrozole | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer | Active, not recruiting | USA | GBR | FRA | ESP | CAN | 0 |
| NCT04632992 | Phase II | Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) | Completed | USA | 0 |
| NCT06496568 | Phase I | Atezolizumab + Inavolisib Inavolisib | A Study Evaluating Single-agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers | Recruiting | USA | CAN | 1 |
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