EGFR TKI (deuterated osimertinib) · small molecule

TY-9591

3 active trials, targeting EGFR. Not approved for any biomarker on marked.bio yet.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 3 5 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of TY-9591.

  1. TYK Medicines 3

Trials

Status

3 of 5 trials shown

  1. Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

    Recruiting Phase 3 TYK Medicines Started 2022Primary completion 2025-05 NCT05382728

    TY-9591osimertinib FDA EU

    Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites)…

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-01-30NSCLC, EGFR Activating Mutation

  2. A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC

    Not yet recruiting Phase 2 TYK Medicines Started 2025Primary completion 2027-12 NCT06672068

    TY-9591pemetrexedcisplatincarboplatin

    Tissue or blood samples tested positive for EGFR sensitive mutations (including exon 19 deletion, exon 21 L858R mutation, alone or in combination with other EGFR mutations) by central la…

    EGFR exon 19 deletion / L858RNSCLC

  3. TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

    Recruiting Phase 2 TYK Medicines Started 2023Primary completion 2025-12 NCT05948813

    TY-9591osimertinib FDA EU

    Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites)…

    EGFR exon 19 deletion / L858RNSCLC, EGFR Activating Mutation, Brain Metastases