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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 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, Not yet recruiting, Hoffmann-La Roche
    New P2 trial
    |
    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)
    4d
    GO42144: A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation (clinicaltrials.gov)
    P1, N=498, Active, not recruiting, Genentech, Inc. | Trial completion date: Sep 2026 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Tecentriq (atezolizumab) • erlotinib • divarasib (RG6330) • Itovebi (inavolisib) • migoprotafib (RLY-1971)
    7d
    INAVO-CRC: A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Hoffmann-La Roche | N=164 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • Itovebi (inavolisib)
    10d
    A Three-subtype Molecular model of Cervical Cancer: Multiple PI3K Pathway inhibitors suppress growth and cooperate with HPV-directed immunotherapy. (PubMed, medRxiv)
    The pan-AKT inhibitor, Capivasertib (AZD5363), suppressed some but not all tested PIK3CA -mutated cell lines and one PIK3CA -wt cell line (SiHa). Further research on targeted therapies will improve the prognosis of patients with cervical cancer. Identified 3 molecular subtypes of CC based on PIK3CA and YAP1 amplification status Cervical cell lines with PIK3CA mutation are suppressed by targeted inhibitors PI3K inhibitors Alpelisib/Inavolisib selectively block PIK3CA-mutant cells PIK3CA mutation is associated with higher expression of the checkpoint CD274/PD-L1 PI3K inhibitors cooperate with donor-derived T cells to kill cervical cells.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • YAP1 (Yes associated protein 1)
    |
    EGFR mutation • PIK3CA mutation • HLA-A*02 positive
    |
    Piqray (alpelisib) • Truqap (capivasertib) • Itovebi (inavolisib)
    14d
    A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (clinicaltrials.gov)
    P1, N=542, Recruiting, Hoffmann-La Roche | Trial completion date: Nov 2028 --> Aug 2030 | Trial primary completion date: Aug 2027 --> Aug 2030
    Trial completion date • Trial primary completion date
    |
    FoundationOne® Liquid CDx
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Tecentriq (atezolizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • divarasib (RG6330) • Itovebi (inavolisib) • SY-5609 • tiragolumab (RG6058)
    20d
    optINAVO: To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Hoffmann-La Roche
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Itovebi (inavolisib)
    24d
    reaINAVO: A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=500, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    26d
    Cost-effectiveness analysis of inavolisib combined with palbociclib plus fulvestrant in PIK3CA-mutated HR+/Her2- advanced breast cancer in China. (PubMed, Front Pharmacol)
    While inavolisib plus palbociclib-fulvestrant significantly prolongs PFS and OS in PIK3CA-mutated HR+/HER2- ABC/MBC, it is not cost-effective at current prices in China. Strategic price adjustments or reimbursement negotiations are essential to improve economic feasibility and inform clinical and policy decisions.
    Journal • HEOR • Cost-effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    EGFR mutation • HR positive • HER-2 negative • PIK3CA mutation • EGFR positive
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    1m
    reaINAVO: A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P=N/A, N=500, Not yet recruiting, Hoffmann-La Roche
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    1m
    InavoPC: A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FoundationOne® CDx
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Itovebi (inavolisib)
    1m
    INAVO-CRC: A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer (clinicaltrials.gov)
    P2, N=164, Not yet recruiting, Hoffmann-La Roche
    New P2 trial
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • Itovebi (inavolisib)
    1m
    Cost-effectiveness of inavolisib plus palbociclib-fulvestrant versus palbociclib plus fulvestrant as first-line treatment in HR+/HER2-advanced breast cancer. (PubMed, Breast)
    Compared with palbociclib-fulvestrant, the inavolisib triple regimen is not cost-effective at its current price. A substantial price reduction or careful selection of the target patient may be required for the regimen to be economically viable.
    Journal • HEOR • Cost-effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)