Therapy Detail
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| Therapy Name | Inavolisib |
| Synonyms | |
| Therapy Description |
Inavolisib (GDC-0077) 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). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Inavolisib | GDC-0077|RO7113755|RG6114|GDC0077|GDC 0077 | PIK3CA inhibitor 21 | Inavolisib (GDC-0077) 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PIK3CA E545K | breast cancer | sensitive | Inavolisib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Inavolisib (GDC-0077) treatment led to tumor regression in an ESR1 (ER)-positive breast cancer cell line xenograft model harboring PIK3CA E545K (PMID: 34544753). | 34544753 |
| 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 Inavolisib (GDC-0077) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| 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 Inavolisib (GDC-0077) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA mutant | breast cancer | predicted - sensitive | Inavolisib | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, Inavolisib (GDC-0077) 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 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 Inavolisib (GDC-0077) 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, GDC-0077 decreased viability of a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA E726K in culture (PMID: 37916958). | 37916958 |
| PIK3CA E545K | colon cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Inavolisib (GDC-0077) treatment led to decreased cell viability in a colon cancer cell line expressing PIK3CA E545K in culture (PMID: 34544753). | 34544753 |
| 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 Inavolisib (GDC-0077) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). | 31699932 |
| PIK3CA H1047R | colon cancer | sensitive | Inavolisib | Preclinical - Cell culture | Actionable | In a preclinical study, Inavolisib (GDC-0077) treatment led to decreased cell viability in a colon cancer cell line expressing PIK3CA H1047R in culture (PMID: 34544753). | 34544753 |
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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 | Recruiting | USA | GBR | FRA | ESP | CAN | 0 |
| NCT04589845 | Phase II | Alectinib Ado-trastuzumab emtansine Ipatasertib Inavolisib Entrectinib Atezolizumab Idasanutlin | Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 15 |
| 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) | Active, not recruiting | USA | 0 |
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