Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Talazoparib · 1 trial · 3 indications
Objective response (OR) is a common measure of benefit. OR is defined as the number of participants who achieved complete response (CR) or partial clinical (PR), per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (v1.1). RECIST Criteria are assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays, as follows: * CR = Disappearance of all target and non-target lesions * PR = ≥30% decrease in the sum of the long diameter of target lesions * OR = CR+PR * Stable disease (SD) = Small changes that do not meet any of the above criteria * Progressive disease (PD) = ≥20% increase in long diameter of target lesions, and/or the appearance of any new lesion(s) The outcome is expressed as the number of participants that achieved either CR or PR within 24 weeks of the start of treatment, a number without dispersion.
| Arm | Type | Description |
|---|---|---|
| Cohort A - Triple-negative Breast Cancer | EXPERIMENTAL | Participants with advanced triple-negative breast cancer (TNBC) with homologous recombination deficiency (HRD) based on the Myriad HRD Assay. Participants receive talazoparib 1 mg by mouth daily. |
| Cohort B - HER2-negative solid tumor | EXPERIMENTAL | Participants with advanced HER2-negative solid tumor with a deleterious hereditary or cancer somatic mutation in one of the following genes: PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, RAD51C, RAD51D, MRE11, ATR, Fanconi anemia complementation group of genes. Participants receive talazoparib 1 mg by mouth daily. |
| Name | Type | Description |
|---|---|---|
| Talazoparib Tosylate | DRUG | Participants receive Talazoparib tosylate at 1 mg by mouth daily. |
INCLUSION CRITERIA: * No deleterious germline BRCA1 or BRCA2 mutation based on full sequencing and comprehensive rearrangement testing at an external reference laboratory; patients with variants of unknown significance will be eligible * Measurable disease per Response Evaluation Criteria In Solid ...
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Talazoparib is an investigational small molecule being studied for the treatment of advanced breast cancer, including HER2-negative and triple-negative breast cancer. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Talazoparib is a small molecule that targets PARP enzymes, which are involved in DNA repair. By inhibiting these enzymes, it may interfere with cancer cell survival. The drug is being studied in patients with BRCA1/2 wild-type HER2-negative breast cancer.
Talazoparib is being developed by BioMarin Pharmaceutical Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BMRN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in advanced breast cancer.
Talazoparib is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval and is still being studied in clinical trials to determine its safety and effectiveness for treating advanced breast cancer.
Talazoparib has been studied in a Phase 2 clinical trial with the identifier NCT02401347. This completed trial enrolled 21 participants with advanced breast cancer, including HER2-negative and triple-negative breast cancer, and was conducted in the United States.
Talazoparib is a PARP inhibitor, a class of drugs that target DNA repair mechanisms in cancer cells. It is being studied specifically in BRCA1/2 wild-type HER2-negative breast cancer, which distinguishes it from other PARP inhibitors that may be used in different patient populations.