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BAY2757556 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1_NSCLC | EXPERIMENTAL | Patients with solid non-small cell lung cancer (NSCLC) harboring NTRK fusions (arm closed) |
| Arm 2_Thyroid | EXPERIMENTAL | Patients with solid thyroid tumors harboring NTRK fusions (arm closed) |
| Arm 3_Sarcoma | EXPERIMENTAL | Patients with soft-tissue sarcoma harboring NTRK fusions (arm closed) |
| Arm 4_Colorectal | EXPERIMENTAL | Patients with solid colorectal tumors harboring NTRK fusions (arm closed) |
| Arm 5_Salivary | EXPERIMENTAL | Patients with solid salivary tumors harboring NTRK fusions (arm closed) |
| Arm 6_Biliary | EXPERIMENTAL | Patients with solid biliary tumors harboring NTRK fusions (arm closed) |
| Arm 7_Primary CNS | EXPERIMENTAL | Patients with solid tumors in the primary central nervous system (CNS) harboring NTRK fusions (arm closed) |
| Arm 8_Other tumors | EXPERIMENTAL | Patients with e.g. kidney cancer, squamous cell cancer of head or neck or ovarian solid tumors harboring NTRK fusions (arm closed) |
| Arm 9_Solid tumors without confirmed NTRK fusion | EXPERIMENTAL | Patients eligible for arms 1 to 8, but with documented NTRK fusion from a laboratory where CLIA or equivalent certification cannot be confirmed by the sponsor at the time of consent (arm closed) |
| Arm 10_Prospective cohort | EXPERIMENTAL | Patients with melanoma, non secretory breast and colorectal cancer or other tumor types harboring NTRK fusions, except soft tissue sarcoma, salivary gland and thyroid cancer (arm closed) |
| Arm 11_Bone health cohort | EXPERIMENTAL | Patients with all tumor types harboring NTRK fusions, not eligible for the main prospective cohort, including patients with non-measurable disease |
| Name | Type | Description |
|---|---|---|
| BAY2757556 (Larotrectinib, Vitrakvi) | DRUG | Larotrectinib will be administered orally as capsule or liquid solution at a dose of 100 mg twice daily in continuing 28-days cycles. |
Inclusion Criteria: * Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories. Subjects who have an NTRK gene fusion identified in a lab where CLIA or equivalen...
BAY2757556 is an investigational small molecule being studied for the treatment of solid tumors harboring NTRK fusion. It is in Phase 2 clinical development for this oncology indication. The drug is not approved and remains under clinical investigation.
BAY2757556 is being developed by Bayer AG, a multinational pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 2 clinical development for solid tumors harboring NTRK fusion.
BAY2757556 is in Phase 2 clinical development. It is an investigational drug for solid tumors harboring NTRK fusion and has not been approved by regulatory authorities. One Phase 2 clinical trial for the drug has been completed.
BAY2757556 has been studied in one clinical trial, NCT02576431, a Phase 2 study in adults and children with NTRK-fusion positive solid tumors. The trial, which enrolled 215 participants, is completed. The study was conducted across multiple countries including the United States, Germany, and Japan.
BAY2757556 is not the same as larotrectinib. The clinical trial NCT02576431, which studied BAY2757556, is titled as a study of larotrectinib, indicating the two names refer to the same drug. BAY2757556 is an alternative identifier for larotrectinib in this context.