Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design

Agarwal, N; Azad, A; Shore, ND; Carles, J; Fay, AP; Dunshee, C; Karsh, LI; Paccagnella, ML; Di Santo, N; Elmeliegy, M; Lin, X; Czibere, A; Fizazi, K

Author(s): Agarwal, N; Azad, A; Shore, ND; Carles, J; Fay, AP; Dunshee, C; Karsh, LI; Paccagnella, ML; Di Santo, N; Elmeliegy, M; Lin, X; Czibere, A; Fizazi, K;
Details: Publication Year 2022-02,Volume 18,Issue #4,Page 425-436
Journal Title: Future Oncology
Publication Type: Protocol
Abstract: PARP inhibitors in combination with androgen receptor-targeted therapy have demonstrated potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Here, we describe the design and rationale of the multinational, phase III, two-part TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide as a first-line treatment for patients with mCRPC with or without DNA damage response (DDR) alterations. This study has two co-primary end points: radiographic progression-free survival (rPFS) by blinded independent clinical review in all-comers (cohort 1) and in patients with DDR alterations (cohort 2). TALAPRO-2 will demonstrate whether talazoparib plus enzalutamide can significantly improve the efficacy of enzalutamide in terms of rPFS in both molecularly unselected and DDR-deficient patients with mCRPC (NCT03395197). Clinical Trial Registration: NCT03395197 (ClinicalTrials.gov).
Keywords: Androgen Receptor Antagonists/therapeutic use; Antineoplastic Combined Chemotherapy Protocols/*therapeutic use; Benzamides/*therapeutic use; DNA Damage/drug effects/genetics; Humans; Male; Neoplasm Metastasis; Nitriles/*therapeutic use; Phenylthiohydantoin/*therapeutic use; Phthalazines/*therapeutic use; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use; Progression-Free Survival; Prostatic Neoplasms, Castration-Resistant/*drug therapy/pathology; Ddr; PARP inhibitor; androgen receptor; enzalutamide; mCRPC; talazoparib
Department(s): Medical Oncology
PubMed ID: 35080190
Publisher's Version: https://doi.org/10.2217/fon-2021-0811
Open Access at Publisher's Site: https://doi.org/10.2217/fon-2021-0811
Terms of Use/Rights Notice: Refer to copyright notice on published article.

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