Name:
VJBM-2022-0005
Description:
VJBM-2022-0005
Thumbnail URL:
https://cadmoremediastorage.blob.core.windows.net/a04d6baf-f328-4a62-8da4-af1f0804cfd1/videoscrubberimages/Scrubber_4.jpg?sv=2019-02-02&sr=c&sig=IwTMv1yyrjYw7UrNohr%2BB4UTQLH3exnny%2BjN%2Fx%2Fo5oo%3D&st=2024-11-23T15%3A24%3A09Z&se=2024-11-23T19%3A29%3A09Z&sp=r
Duration:
T00H05M20S
Embed URL:
https://stream.cadmore.media/player/a04d6baf-f328-4a62-8da4-af1f0804cfd1
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/a04d6baf-f328-4a62-8da4-af1f0804cfd1/VJBM - TALAPRO-2- v13.mp4?sv=2019-02-02&sr=c&sig=iUgO7GwPCUHJpUxQYJ3P3CZ4aSMMbSxD5s%2BcAWMNG5Y%3D&st=2024-11-23T15%3A24%3A10Z&se=2024-11-23T17%3A29%3A10Z&sp=r
Upload Date:
2022-07-05T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
[MUSIC PLAYING]
SPEAKER: There have been significant advances in the therapeutic landscape of Metastatic Castrate-Resistant Prostate Cancer, or MCRPC in recent years. Despite this progress, currently available therapies are associated with responses that are short integration and subsequent progression of disease that usually reflects reactivation of the androgen signaling pathway. As a result, patients with MCRPC often require additional therapeutic approaches or combination therapies as part of their treatment.
SPEAKER: Talazoparib blocks the activity of poly ADP-ribose polymerase or PARP, and traps PARP on the single strand DNA breaks. This results in the prevention of DNA repair and death of the cells with defects and DNA damage repair such as those with BRCA1 or 2 mutations. The PARP inhibitor talazoparib has been approved in multiple countries as a monotherapy for the treatment of patients with germline BRCA1, 2 mutated, HER2-negative advanced breast cancer.
SPEAKER: Prior studies have suggested the potential benefit of PARP inhibitors in the treatment of advanced prostate cancer. Indeed studies have indicated that PARP activity supports androgen receptor function. And therefore, PARP inhibition is expected to reduce androgen receptor signaling and complement the effect of androgen receptor directed therapies.
SPEAKER: In addition, blockade of androgen receptor down regulates homologous recombination repair gene transcription which has been shown to induce brokenness. Building on these prior results, TALAPRO-2 is a multinational phase 3, two part study that aims to evaluate whether the combination of talazoparib with enzalutamide, and establish androgen receptor inhibitor may improve clinical outcomes in metastatic CRPC.
SPEAKER: Part one of TALAPRO-2 was an open label study to confirm the starting dose of talazoparib in combination with enzalutamide. Part two is a randomized double blind study that evaluates the safety, efficacy, in patient reported outcomes, in patients receiving talazoparib of 0.5 milligrams daily, plus enzalutamide at 160 milligrams daily, versus patients receiving placebo plus enzalutamide. Randomization is stratified by prior novel hormonal therapy for castration-sensitive prostate cancer or CSPC, taxane-based chemotherapy for CSPC, and DNA damage repair mutation status.
SPEAKER: To be eligible to take part in TALAPRO-2 trial, patient must be 18 years or older with asymptomatic or mildly asymptomatic metastatic CRPC. Other key inclusion criteria include an ecog performance status of one or less and the presence of metastatic disease. Patients are not eligible to take part in this trial if they have received prior life prolonging systemic therapy for CRPC, which include non-metastatic or metastatic CRPC, with the exception of prior treatment with androgen deprivation therapy and first generation anti-androgen such as by glutamate.
SPEAKER: Briefly, the primary endpoint is radiographic progression free survival, which is defined as progression in soft tissue as per recist 1.1 or in bones as per the prostate cancer clinical trials working group three criteria. Secondary endpoint is overall survival. Efficacy will be assessed radiographically every eight weeks up to week 25, and every eight to 12 weeks afterwards.
SPEAKER: Radiographic progression free survival will be compared between the two arms by one-sided stratified logrank test. Radiographic progression free survival and overall survival will be evaluated in patients who are unselected for DNA damage repair mutation, as well as in patients with DNA damage repair mutations. TALAPRO-2 study is now well underway in 26 countries.
SPEAKER: We are hoping to see positive results that will improve our understanding of the potential of PARP inhibitors in combination with androgen receptor directed therapies in the treatment of metastatic CRPC. Thank you very much for your attention.
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