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First Participant Dosed in Pfizers Pivotal Phase 3 Talapro-3

Study explores combination in patients with DNA damage response alterations before prostate cancer becomes castration resistant

Pfizer Inc. today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. 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 Glendale, California.

“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 Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “By combining enzalutamide, which has a proven clinical benefit in men with metastatic castration-sensitive prostate cancer, with talazoparib, our PARP inhibitor that is active in DDR-mutated cancer, we may be able to offer a new treatment option that targets the underlying genetic mechanisms associated with DDR-mutated mCSPC.”

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.

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“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 Neeraj Agarwal, M.D., Professor of Oncology at the University of Utah School of Medicine, Senior Director for Clinical Research Innovation at Huntsman Cancer Institute and member of the TALAPRO-3 steering committee. “It’s exciting to be at the forefront of landmark studies like TALAPRO-3, which are helping to further our understanding of how different approaches may advance care for these men.”

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, Pfizer and Astellas jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

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).

Source: Pfizer
Date: Jun 23, 2021


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