The Combination of Enzalutamide Plus Talazoparib for Patients With Castration-Sensitive Metastatic Prostate Cancer With HRR Gene Alterations (TALAPRO-3) - Neeraj Agarwal
March 4, 2023
ClinicalTrials.gov Identifier: NCT04821622
TALAPRO-3: A Phase 3, randomized, double-blind, study of talazoparib with enzalutamide versus placebo with enzalutamide in men with DDR gene mutated metastatic castration-sensitive prostate cancer
Biographies:
Neeraj Agarwal, MD, Professor, Presidential Endowed Chair of Cancer Research, Director GU Program, and the Center of Investigational Therapeutics (CIT) at the Huntsman Cancer Institute, University of Utah, Salt Lake City, UT
Alicia Morgans, MD, MPH, Genitourinary Medical Oncologist, Medical Director of Survivorship Program at Dana-Farber Cancer Institute, Boston, Massachusetts
TALAPRO-3 Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) – Neeraj Agarwal
ESMO 2021: TALAPRO-3: A Phase 3, Double-blind, Randomized Study of Enzalutamide Plus Talazoparib vs Placebo Plus Enzalutamide in Patients with DDR Gene Mutated Metastatic Castration-sensitive Prostate Cancer (mCSPC)
Alicia Morgans: Hi. I'm so excited to be here with Professor Neeraj Agarwal to talk about the TALAPRO-3 trial. Thank you so much for talking with me today.
Neeraj Agarwal: It's always a pleasure.
Alicia Morgans: This is certainly a study that has not yet reported out, but it is a study that I believe may have completed accrual. So tell me a little bit about the trial design. And what kind of results are we hoping to find?
Neeraj Agarwal: So TALAPRO-3 is a Phase III trial in patients with metastatic hormone-sensitive prostate cancer or castration-sensitive prostate cancer who harbor DNA repair gene-related alterations or homologous recombination repair gene alterations in the tumors. So it's different from TALAPRO-2 trial, which we presented during the ASCO GU Meeting, which recruited all patients regardless of HRR gene alterations. TALAPRO-3 is only on those patients who have these HRR gene alterations. And these patients are being randomized to enzalutamide plus talazoparib versus enzalutamide plus placebo.
Radiographic progression-free survival is a primary endpoint. And there are several important clinically relevant secondary endpoints. And trial's accrual is going strong, and we expect the accrual to be completed in the near future. And we are really hoping that based on the results of the TALAPRO-2 trial, the signal we saw, especially in the HRR mutation positive patients, we are really hoping for a strongly positive trial. Hopefully, that will establish the combination of enzalutamide plus talazoparib as a standard of care option for patients who have castration-sensitive metastatic prostate cancer with HRR gene alterations.
Alicia Morgans: So really exciting that we might be able to move what seems to be a synergistic or certainly at least additive combination into an earlier line for patients. Can you tell me a little bit about what your assessments are? It's a traditional assessment, I think, in terms of safety. And then are you collecting patient reported outcomes to understand from the patient's perspective what things will be like?
Neeraj Agarwal: Yes, for everything. Yes. So safety is one of the most important aspect of any trial. And same as the case here, patients are being closely followed for all the safety parameters, especially from the hematologic safety perspective. All those data are being collected. Data on other safety such as nausea, vomiting, gastrointestinal safety, adverse events, all those data are being collected. The quality of life is being monitored by standardized scales, which are validated, which are accepted by, approved by regulatory bodies. So all those scales are being used to assess quality of life. And overall survival, as I said, is one of the important endpoints. So ultimately, when the trial reads out, we are really hoping to have a comprehensive assessment of not only efficacy, but efficacy, safety and quality of life aspects of this combination available for our patients.
Alicia Morgans: Wonderful. Well, I look forward to talking with you more about this really exciting combination and the opportunity to understand data as it moves into an earlier phase. Thank you so much for your time and your expertise.
Neeraj Agarwal: Thank you very much for having me here.