Neeraj Agarwal, MD, on the design of the TALAPRO-2 trial

In this video, Neeraj Agarwal, MD, FASCO, shares the background for the study, “Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial,” which was presented at the 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco, California.

Agarwal is a professor of medicine and the director of the genitourinary oncology program at the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

Video Transcript:

TALAPRO-2 was a large phase 3 trial in patients with metastatic castrate-resistant prostate cancer. To simplify this for our viewers, it was rather 2 trials within 1 trial. So, the trial had 2 cohorts. Cohort 1was all-comer, unselected patients with metastatic castrate-resistant prostate cancer who were recruited first. These were 805 patients in total. These patients could not have received any prior treatment for castration-resistant disease. After conclusion of the recruitment of these 805 all-comer patients, the study went ahead and recruited another set of patients who were known to have HRR gene mutations in their tumors. So, cohort 1 and cohort 2. I'll focus on cohort 1 data, which is the all-comer patient population. This is a larger number of patients we are talking about here.

These patients who had not received any treatment for their castration-resistant disease, they were randomized to the combination of enzalutamide plus talazoparib—so combination of an androgen receptor pathway inhibitor, enzalutamide and a PARP inhibitor, talazoparib vs enzalutamide plus placebo. Enzalutamide here is an active control just to make this point, because we will see in a moment that the survival benefit seen with enzalutamide in this trial was very similar to what was seen in the original PREVAIL trial, which led to approval of enzalutamide in this setting. So, moving to the primary end points. The primary end point was radiographic progression-free survival, which we reported in 2023, and we updated the radiographic progression-free survival data in 2025. We also presented the overall survival benefit. Overall survival was a key secondary end point, which was alpha protected, meaning the trial was statistically powered to answer the overall survival question, whether it improves or not. There were many other secondary end points, such as quality of life, such as time to chemotherapy, which are quite meaningful to our patients.

This transcript was AI generated and edited by human editors for clarity.