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    DRUG:

    Itovebi (inavolisib)

    i
    Other names: GDC-0077, GDC 0077, GDC0077, RG6114, RG-6114, RG 6114, RO7113755, RO 7113755, RO-7113755
    Company:
    Roche
    Drug class:
    PI3Kα inhibitor
    Related drugs:
    3d
    A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer (clinicaltrials.gov)
    P=N/A, N=100, Not yet recruiting, xuliang
    New trial • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    HER-2 negative • PIK3CA mutation
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    Itovebi (inavolisib)
    5d
    Integrating PIK3CA Testing into Clinical Practice for Advanced HR+/HER2- Breast Cancer: An Expert Consensus. (PubMed, Breast)
    This consensus document provides operational and interpretative guidelines aimed at standardizing PIK3CAtesting and assessing related genes in clinical practice. These recommendations promote a harmonized approach to patient care, in line with the latest scientific evidence.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    HER-2 negative • PIK3CA mutation
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    Piqray (alpelisib) • Itovebi (inavolisib)
    9d
    Economic Evaluation of Inavolisib Combined With Palbociclib-Fulvestrant for PIK3CA-Mutated, HR+/HER2- Advanced Breast Cancer in USA. (PubMed, Technol Cancer Res Treat)
    To achieve cost-effectiveness at WTP thresholds of $100,000, $150,000, and $200,000 per QALY, the per-cycle price of inavolisib would need to be reduced to 59.5%, 72.0%, and 86.5% of its current price, respectively.ConclusionFor patients with PIK3CA-mutated HR+/HER2- ABC, the inavolisib regimen is not cost-effective in the U.S. healthcare setting. Negotiating price reductions and adjusting decision thresholds based on patient characteristics may be viable strategies to meet the extensive treatment demand in the U.S.
    Journal • HEOR
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive
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    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    10d
    PIK3CA mutant cervical cancer is selectively suppressed by PI3Kα inhibition (Alpelisib/BYL-719 and Inavolisib/GDC-0077) and cooperates with HPV directed T cell therapy. (PubMed, Neoplasia)
    These findings identify actionable molecular subtypes of cervical cancer and support targeting PI3Kα in PIK3CA-mutant tumors. Moreover, combining PI3K inhibition with antigen-specific immunotherapy represents a promising strategy to improve outcomes in advanced HPV16-associated cervical cancer.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • YAP1 (Yes associated protein 1)
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    EGFR mutation • PIK3CA mutation • HLA-A*02 positive
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    Piqray (alpelisib) • Itovebi (inavolisib)
    11d
    Targeting ATR and PI3Kα Pathways Promotes Ferroptosis in PIK3CA-Wildtype Platinum-Resistant Endometrial Cancer. (PubMed, Cancers (Basel))
    A panel of EC cell lines, including patient-derived models with varying PIK3CA mutation status and platinum sensitivity, was treated with camonsertib (ATR inhibitor) and inavolisib (PI3Kα inhibitor). Our findings establish dual ATR and PI3Kα inhibition as a genotype-informed therapeutic strategy for platinum-resistant EC. PIK3CA mutation status may influence the mode of cell death, supporting its use as a predictive biomarker for patient stratification in future clinical applications.
    Journal • PARP Biomarker • Platinum resistant
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CASP3 (Caspase 3) • ANXA5 (Annexin A5)
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    PIK3CA mutation
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    Itovebi (inavolisib) • camonsertib (RP-3500)
    11d
    UmbrellaMAX: A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study (clinicaltrials.gov)
    P3, N=100, Recruiting, Hoffmann-La Roche | N=23 --> 100
    Enrollment change
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    Avastin (bevacizumab) • Rozlytrek (entrectinib) • ipatasertib (RG7440) • divarasib (RG6330) • Itovebi (inavolisib) • tiragolumab (RG6058)
    11d
    Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4 (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, National Cancer Institute, Naples
    New P2 trial
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    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
    |
    PIK3CA mutation • PTEN mutation
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    Itovebi (inavolisib)
    16d
    PIK3CA testing in HR+/HER2- metastatic breast cancer: assessing pathology laboratories capacity and needs. (PubMed, Pathologica)
    We conducted a nationwide, cross-sectional survey to evaluate current practices and institutional readiness for PIK3CA testing in Italy, in the context of the anticipated expansion of PI3K-targeted therapies, including inavolisib...Nevertheless, persistent gaps in accreditation, heterogeneous workflows, and limited integration of liquid biopsy highlight ongoing challenges in standardization and diagnostic equity. Coordinated national strategies will be essential to ensure consistent, high-quality molecular diagnostics in HR+/HER2- MBC.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 positive • HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
    |
    Itovebi (inavolisib)
    16d
    InavoPC: A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Hoffmann-La Roche | N=32 --> 100 | Trial primary completion date: May 2027 --> Mar 2028
    Enrollment change • Trial initiation date • Trial primary completion date
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    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Itovebi (inavolisib)
    18d
    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 (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche | N=44 --> 80 | Trial completion date: Dec 2030 --> Feb 2030
    Enrollment change • Trial completion date • Trial initiation date
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    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
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    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)
    22d
    Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (clinicaltrials.gov)
    P2, N=920, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • Tumor mutational burden • IO biomarker • Pan tumor
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    BRAF (B-raf proto-oncogene)
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    Tecentriq (atezolizumab) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Gavreto (pralsetinib) • ipatasertib (RG7440) • belvarafenib (RG6185) • divarasib (RG6330) • Itovebi (inavolisib) • camonsertib (RP-3500)
    23d
    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 (clinicaltrials.gov)
    P2, N=38, Recruiting, Hoffmann-La Roche | N=14 --> 38
    Enrollment change
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    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
    |
    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)