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 23 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 PIK3CA I817F breast cancer sensitive Inavolisib Preclinical - Cell culture Actionable In a preclinical study, Inavolisib (GDC-0077) decreased viability of a breast cancer cell line harboring PIK3CA E545K and expressing PIK3CA I817F in culture (PMID: 37916958). 37916958
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 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 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 E545K PIK3CA E726K breast cancer sensitive Inavolisib Preclinical - Cell culture Actionable In a preclinical study, Inavolisib (GDC-0077) decreased viability of a breast cancer cell line harboring PIK3CA E545K and expressing PIK3CA E726K in culture (PMID: 37916958). 37916958
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, Inavolisib (GDC-0077) decreased viability of a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA E726K in culture (PMID: 37916958). 37916958
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
PIK3CA I817F PIK3CA H1047R breast cancer sensitive Inavolisib Preclinical - Cell culture Actionable In a preclinical study, Inavolisib (GDC-0077) decreased viability of a breast cancer cell line harboring PIK3CA H1047R and expressing PIK3CA I817F 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 Inavolisib (GDC-0077) treatment compared to cells expressing individual PIK3CA mutations in culture (PMID: 31699932). 31699932
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 Inavolisib (GDC-0077) in a patient with ESR1-positive, ERBB2 (HER2)-negative breast cancer harboring PIK3CA N345K and E453K (PMID: 37916958). 37916958
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 Inavolisib (GDC-0077) 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 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 Inavolisib (GDC-0077) 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 Inavolisib (GDC-0077) 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 Inavolisib (GDC-0077) 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 Inavolisib (GDC-0077) 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 Inavolisib (GDC-0077) 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
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
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
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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 14


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