Opinion
Video
Neeraj Agarwal, MD, on the safety profile of talazoparib/enzalutamide in mCRPC
Author(s):
"We should not be preemptively reducing the dose for all our patients, because half of the patients will never develop grade 3/4 anemia," says Neeraj Agarwal, MD, FASCO.
Data from the phase 3 TALAPRO-2 trial (NCT03395197) showed that the combination of enzalutamide (Xtandi) plus talazoparib (Talzenna) led to a statistically significant and clinically meaningful improvement in overall survival (OS) vs enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC).1
These data were recently presented at the 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco, California.
In a recent interview with Urology Times®, Neeraj Agarwal, MD, FASCO, shared key safety data from the trial. Agarwal is professor of medicine and the director of the genitourinary oncology program at the Huntsman Cancer Institute of the University of Utah in Salt Lake City.
Agarwal began his discussion by highlight adverse events of special interest, namely myelodysplastic syndrome (MDS) and acute myeloid leukemia.
He explained, “We reported previously in 2023 1 case of MDS and 1 case of acute leukemia. I'm happy to report that we didn't find any more cases at the time of data cutoff for this presentation. So, after 4 years of follow up, we are not seeing any more cases of MDS and leukemia.”
Overall, treatment-emergent adverse events (TEAEs) were generally manageable. In total, 22% of patients discontinued the study due to TEAEs.
The most common grade 3 or higher TEAEs were anemia (49%) and neutropenia (19%). According to Agarwal, the median time to onset of grade 3/4 anemia was 3.3 months, and 8.5% of patients discontinued talazoparib due to anemia.
Agarwal added, “That tells me that we should not be preemptively reducing the dose for all our patients, because half of the patients will never develop grade 3/4 anemia.”
REFERENCE
1. Agarwal N, Azad A, Carles J, et al. 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. J Clin Oncol 43, 2025 (suppl 5; abstr LBA18). doi:10.1200/JCO.2025.43.5_suppl.LBA18
