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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:
    4d
    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
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    FoundationOne® Liquid CDx
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Tecentriq (atezolizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • divarasib (RG6330) • Itovebi (inavolisib) • SY-5609 • tiragolumab (RG6058)
    9d
    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)
    13d
    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)
    16d
    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)
    20d
    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)
    22d
    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)
    29d
    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)
    1m
    Inavolisib-Based Therapy for PIK3CA-Mutated Advanced Male Breast Cancer: A Cost-Effectiveness Analysis. (PubMed, Breast Cancer (Dove Med Press))
    A lifetime Markov model was developed from a US payer perspective to evaluate the cost-effectiveness of inavolisib plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in men with PIK3CA-mutated advanced breast cancer. Inavolisib-based therapy is not cost-effective for treating PIK3CA-mutated advanced male breast cancer at its current price. Significant price reductions or adjustments to value assessment frameworks are required to ensure equitable access for this underserved population.
    Journal • HEOR • Cost-effectiveness
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    1m
    Inavolisib for PIK3CA-mutant non-small cell lung cancer: A case report. (PubMed, Lung Cancer)
    The primary take-away lesson is that selective PI3Kα inhibition with inavolisib can induce potent systemic and intracranial responses in PIK3CA-mutant NSCLC, regardless of the primary oncogenic co-driver. The observed tumor cavitation suggests a potential anti-angiogenic mechanism, warranting further investigation.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    KRAS mutation • EGFR mutation • PIK3CA mutation
    |
    Itovebi (inavolisib)
    1m
    MiRaDoR: A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (clinicaltrials.gov)
    P2, N=1260, Recruiting, MedSIR | Active, not recruiting --> Recruiting
    Enrollment open • Minimal residual disease • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HR positive • HER-2 negative • PIK3CA mutation
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint® • Oncotype DX Breast Recurrence Score®Test
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    1m
    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=60 --> 100
    Enrollment change
    |
    Avastin (bevacizumab) • Rozlytrek (entrectinib) • ipatasertib (RG7440) • divarasib (RG6330) • Itovebi (inavolisib) • tiragolumab (RG6058)