The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC). The first patient was dosed at a site in
'The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,' said
The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. The primary endpoint of the study is radiographic progression-free survival (rPFS), and overall survival (OS) is a secondary endpoint. The anticipated primary completion date is late-2024.
'With the introduction of PARP inhibitors in the metastatic castration-resistant prostate cancer setting, it is important to explore how a combination approach may impact outcomes for men with metastatic castration-sensitive disease,' said
More information about the TALAPRO-3 trial and participating sites may be found at www.clinicaltrials.gov (NCT04821622).
Talazoparib is currently approved under the brand name TALZENNA for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Selection of patients for therapy is based on an FDA-approved companion diagnostic for TALZENNA. Talazoparib is not approved for the treatment of prostate cancer. Enzalutamide is an androgen receptor inhibitor currently approved under the brand name XTANDI and is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and mCSPC. As part of a global agreement,
In addition to the TALAPRO-3 trial, the combination of enzalutamide plus talazoparib is being investigated in TALAPRO-2 (NCT03395197), a two-part, Phase 3, randomized, double-blind, placebo-controlled study in men with metastatic CRPC (with and without DDR defects).
About TALAPRO-3 Trial
The Phase 3, randomized, double-blind, placebo-controlled, global TALAPRO-3 trial (NCT04821622) will enroll 550 men with DDR-deficient mCSPC across approximately 285 clinical trial sites in 28 countries. In the study, participants will be randomly assigned to one of the two treatment groups and receive either talazoparib (0.50 mg once daily) in combination with enzalutamide (160 mg once daily) or placebo capsules identical to talazoparib in combination with enzalutamide. Men with moderate renal impairment at screening may be enrolled and given a lower dose of either talazoparib (0.35 mg once daily) or the placebo.
The primary endpoint of the study is radiographic progression-free survival (rPFS), which is defined as the time from the date of randomization to first objective evidence of radiographic progression or death, whichever occurs first.
About Metastatic Castration-Sensitive Prostate Cancer
Prostate cancer is considered metastatic once it has spread outside of the prostate gland to other parts of the body, such as the lymph nodes, bones, lungs, and liver.i Men are considered castration-sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.ii The prevalence of mCSPC in the
About talazoparib
Talazoparib is an inhibitor of PARP enzymes, which play a role in DNA response. Preclinical studies have demonstrated that talazoparib blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death. Talazoparib is being evaluated in several ongoing clinical trials in prostate cancer, as well as other novel combinations with targeted therapies in various solid tumors.
About XTANDI (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC).
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DISCLOSURE NOTICE: The information contained in this release is as of
This release contains forward-looking information about talazoparib, including its potential benefits and a potential indication in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for talazoparib may be filed in any jurisdictions for the potential indication or for any other indications; whether and when any such applications for talazoparib that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether talazoparib will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of talazoparib; uncertainties regarding the impact of COVID-19 of our business, operations and financial results and competitive developments.
A further description of risks and uncertainties can be found in
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