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    DRUG:

    Hyrnuo (sevabertinib)

    i
    Other names: BAY 2927088, BAY2927088, BAY-2927088
    Company:
    Bayer, Broad Institute
    Drug class:
    EGFR inhibitor, HER2 inhibitor, HER2 exon 20 mutation inhibitor
    Related drugs:
    22d
    SOHO-01: First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P1/2, N=370, Active, not recruiting, Bayer | Trial primary completion date: Dec 2025 --> Nov 2026
    Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation
    |
    Hyrnuo (sevabertinib)
    2ms
    Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer. (PubMed, N Engl J Med)
    Sevabertinib showed antitumor activity in patients with locally advanced or metastatic HER2-mutant NSCLC. Diarrhea was the most common adverse event. (Funded by Bayer; SOHO-01 ClinicalTrials.gov number, NCT05099172.).
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    Hyrnuo (sevabertinib)
    2ms
    Sevabertinib, a Reversible HER2 Inhibitor with Activity in Lung Cancer. (PubMed, Cancer Discov)
    We furthermore demonstrate the activity of sevabertinib in a cancer cell line dependent on a fusion of NRG1, a ligand for the HER2 family member and heterodimerization partner, HER3. Finally, we report patient responses to sevabertinib from a Phase 1/2 clinical trial, indicating potential benefit for patients with HER2-mutant lung cancer.
    Journal
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    HER-2 amplification • HER-2 mutation • EGFR wild-type • HER-2 exon 20 insertion • NRG1 fusion • HER-2 exon 20 mutation
    |
    Hyrnuo (sevabertinib)
    4ms
    A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose (clinicaltrials.gov)
    P1, N=20, Recruiting, Bayer
    New P1 trial
    |
    Hyrnuo (sevabertinib)
    5ms
    HER2 in Non-Small Cell Lung Cancer (NSCLC): Evolution of the Therapeutic Landscape and Emerging Drugs-A Long Way to the Top. (PubMed, Molecules)
    Despite numerous strengths, there is only one FDA/EMA-approved targeted therapy, an antibody-drug conjugate (ADC) called trastuzumab deruxtecan for pretreated patients with HER2 mutant NSCLC...But, two newly developed HER2-specific TKIs with low EGFR WT inhibition (BAY2927088 and zongertinib) reported encouraging results and received the breakthrough therapy designation from the FDA...A section of this paper is dedicated to the role of immunotherapy in HER2-altered NSCLC. The last section of this paper focuses on the drugs under development and their challenges.
    Review • Journal • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • EGFR wild-type
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Hernexeos (zongertinib) • Hyrnuo (sevabertinib)
    9ms
    SOHO-02: A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P3, N=278, Recruiting, Bayer | Trial completion date: May 2028 --> Apr 2029
    Trial completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Hyrnuo (sevabertinib)
    10ms
    panSOHO: A Study to Learn More About How Well Treatment With BAY2927088 Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P2, N=111, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor
    |
    Hyrnuo (sevabertinib)
    10ms
    SOHO-02: A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P3, N=278, Recruiting, Bayer | Trial primary completion date: Jun 2026 --> Apr 2027
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Hyrnuo (sevabertinib)
    11ms
    SOHO-01: First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P1/2, N=370, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 mutation
    |
    Hyrnuo (sevabertinib)
    11ms
    panSOHO: A Study to Learn More About How Well Treatment with BAY2927088 Tablets Works and How Safe It is in Participants Who Have a Solid Tumor with Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P2, N=111, Not yet recruiting, Bayer
    New P2 trial
    |
    Hyrnuo (sevabertinib)
    11ms
    Expanded Access to Provide BAY2927088 for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation (clinicaltrials.gov)
    P=N/A, N=0, Available, Bayer
    New trial
    |
    Hyrnuo (sevabertinib)
    over1year
    SOHO-02: A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2) (clinicaltrials.gov)
    P3, N=278, Recruiting, Bayer | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Hyrnuo (sevabertinib)