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Therapy Name Sevabertinib
Synonyms
Therapy Description

Hyrnuo (sevabertinib) is a mutant-selective EGFR inhibitor with activity against EGFR exon 20 insertions, EGFR exon 19 deletions, EGFR L858R, and EGFR C797S, which potentially results in inhibition of tumor growth (European Journal of Cancer 174 (2022): S9-S10). Hyrnuo (sevabertinib) is FDA-approved for use in patients with non-squamous non-small cell lung cancer harboring ERBB2 (HER2) tyrosine kinase domain activating mutations (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sevabertinib Hyrnuo BAY-2927088|BAY 2927088|BAY2927088 EGFR Exon 20 Insertion Inhibitor 15 EGFR Inhibitor (Pan) 63 HER2 Inhibitor 44 Hyrnuo (sevabertinib) is a mutant-selective EGFR inhibitor with activity against EGFR exon 20 insertions, EGFR exon 19 deletions, EGFR L858R, and EGFR C797S, which potentially results in inhibition of tumor growth (European Journal of Cancer 174 (2022): S9-S10). Hyrnuo (sevabertinib) is FDA-approved for use in patients with non-squamous non-small cell lung cancer harboring ERBB2 (HER2) tyrosine kinase domain activating mutations (FDA.gov).

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  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06760819 Phase II Sevabertinib A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) 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) (panSOHO) Recruiting USA | ITA | FRA | ESP | DNK | CHE | CAN | AUS 3
NCT06452277 Phase III Sevabertinib Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium A Study to Learn More About How Well Sevabertinib (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 of the Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02) Recruiting USA | TUR | SWE | SVK | ROU | POL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG 10
NCT05099172 Phase I Sevabertinib 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) Active, not recruiting USA | NLD | ITA | ISR | FRA | ESP | BRA | BEL 7


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