FDA Approves Talazoparib/Enzalutamide in HRR-Mutant mCRPC

Article

Patients with HRR-mutant metastatic castration-resistant prostate cancer can now receive treatment with talazoparib and enzalutamide following the regimen’s approval by the FDA.

"TALAPRO-2 is the first phase 3 study to evaluate talazoparib plus enzalutamide as a first-line treatment in patients with metastatic castration resistant prostate cancer," according to lead study author Arun Azad, MBBS, PhD, FRACP, a medical oncologist at Peter MacCallum Cancer Centre, Australia.

"TALAPRO-2 is the first phase 3 study to evaluate talazoparib plus enzalutamide as a first-line treatment in patients with metastatic castration resistant prostate cancer," according to lead study author Arun Azad, MBBS, PhD, FRACP, a medical oncologist at Peter MacCallum Cancer Centre, Australia.

The FDA has approved a combination of talazoparib (Talzenna) and enzalutamide for the treatment of homologous recombination repair (HRR) gene–mutant metastatic castration-resistant prostate cancer (mCRPC), according to a press release from the regulatory agency.1

The agent’s efficacy was evaluated as part of the phase 3 TALAPRO-2 (NCT03395197) trial,2 in which 399 patients with HRR gene–mutant mCRPC were randomly assigned 1:1 to be treated with 160 mg of enzalutamide plus 0.5 mg of either talazoparib or placebo.

These and other findings from the trial were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

The experimental regimen resulted in a significantly improved radiographic progression-free survival (rPFS), the median of which was not reached, compared with a median of 13.8 months in the placebo arm (Hazard ratio [HR], 0.45; 95% CI, 0.33-0.61; P <.0001). When rPFS was assessed in patients with BRCA-mutant disease, investigators reported an HR of 0.20 (95% CI, 0.11-0.39) compared with 0.72 (95% CI, 0.49-1.07) in the non-BRCA–mutant population.

“TALAPRO-2 is the first phase 3 study to evaluate talazoparib plus enzalutamide as a first-line treatment in patients with metastatic castration resistant prostate cancer, or mCRPC…. Here we provide a detailed overview of the safety profile of talazoparib plus enzalutamide in the all-comers population of the TALAPRO-2 trial, with the aim of understanding how adverse events were managed,” lead study author Arun Azad, MBBS, PhD, FRACP, a medical oncologist at Peter MacCallum Cancer Centre, Australia, said in a presentation of the findings.

According to the press release, there are several adverse effects commonly associated with the regimen, including “decreased hemoglobin, decreased neutrophils, decreased lymphocytes, fatigue, decreased platelets, decreased calcium, nausea, decreased appetite, decreased sodium, decreased phosphate, fractures, decreased magnesium, dizziness, increased bilirubin, decreased potassium, and dysgeusia.”

Among those who were treated with talazoparib and enzalutamide, 39% needed a blood transfusion and 22% needed multiple transfusions. Additionally, 2 patients were diagnosed with myelodysplastic syndrome/acute myeloid leukemia.

References

  1. FDA approves talazoparib with enzalutamide for HRR gene-mutated metastatic castration-resistant prostate cancer. News release. FDA. June 20, 2023. Accessed June 21, 2023. https://bit.ly/3pcuSTH
  2. Azad A, Fizazi K, Matsubara N, et al. Talazoparib (TALA) plus enzalutamide (ENZA) in metastatic castration-resistant prostate cancer (mCRPC): safety analyses from the randomized, placebo (PBO)-controlled, phase 3 TALAPRO-2 study. J Clin Oncol. 2023;41(suppl 16):5053. doi:10.1200/JCO.2023.41.16_suppl.5053
Recent Videos
A phase 1 trial assessed the use of PSCA-directed CAR T cells in patients with metastatic castration-resistant prostate cancer.
Findings from a phase 1 study may inform future trial designs intended to yield longer responses with PSCA-targeted CAR T cells.
A phase 1 trial assessed the use of PSCA-directed CAR T cells in patients with metastatic castration-resistant prostate cancer.
Two women in genitourinary oncology discuss their experiences with figuring out when to begin a family and how to prioritize both work and children.
Over the past few decades, the prostate cancer space has evolved with increased funding for clinical trial creation and enrollment.
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Anemia in patients who receive talazoparib plus enzalutamide for metastatic castration-resistant prostate cancer appears to be manageable without any compromises in patient-reported outcomes and quality of life.
Related Content