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Also known as Talazoparib, Talazoparib with enzalutamide, Talazoparib Tosylate
talazoparib plus enzalutamide · 2 trials · 1 indication
time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first
Best ORR was defined as the percentage of participants with best overall soft tissue response of complete response (CR) or partial response (PR) as per RECIST1.1 by an independent central review. RECIST 1.1 criteria, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than 10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than 10 mm short axis); PR: at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Talazoparib plus enzalutamide |
| Arm 2 | ACTIVE_COMPARATOR | Placebo plus enzalutamide |
| Talazoparib | EXPERIMENTAL | Talazoparib 1 mg daily |
| Name | Type | Description |
|---|---|---|
| talazoparib plus enzalutamide | DRUG | experimental arm |
| Placebo plus enzalutamide | DRUG | Active comparator arm |
| Talazoparib | DRUG | 1 mg daily |
Inclusion Criteria: 1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea). 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the partici...
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Talazoparib is an investigational small molecule PARP inhibitor being studied in oncology. Clinical trials have evaluated it in advanced solid tumors, breast neoplasms, metastatic breast cancer with BRCA mutations, and prostate cancer with DDR gene mutations. It is being developed by Pfizer, Inc. (PFE).
Talazoparib targets PARP, which stands for poly (ADP-ribose) polymerase. As a PARP inhibitor, it interferes with DNA repair mechanisms in cancer cells. This target class is commonly studied in tumors with BRCA or other DNA damage response gene mutations.
Talazoparib is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company is conducting clinical trials of the drug across multiple countries, including the United States, Japan, China, and various European nations.
Talazoparib is in Phase 1 clinical development, with completed Phase 1 studies in Japanese and Chinese patients with advanced solid tumors. It has also been studied in Phase 3 trials for breast cancer and prostate cancer, though the drug remains investigational and not approved.
Talazoparib has been studied in four clinical trials. NCT01945775 was a Phase 3 study in advanced breast cancer with BRCA mutations. NCT03343054 and NCT04635631 were Phase 1 studies in Japanese and Chinese patients with advanced solid tumors. NCT04821622 is an active Phase 3 trial in prostate cancer.
Yes, Talazoparib is also known as Talazoparib Tosylate. It is sometimes referred to as talazoparib with enzalutamide or talazoparib plus enzalutamide when studied in combination. These names refer to the same investigational drug.