marked.bio

androgen receptor inhibitor · small molecule

enzalutamide

3 active trials across 3 of our biomarkers, targeting androgen receptor. 2 active approvals for a biomarker on marked.bio.

Also known as MDV3100, Xtandi.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
talazoparib with enzalutamide
FDA, 2023
mCRPC with HRR gene mutation Label 1.2: HRR gene-mutated mCRPC. The EU combination is not biomarker-restricted. Year confirmed: FDA approval announced 20/06/2023. Source
FDA, 2026
metastatic castration-sensitive (androgen pathway modulation-naive or -sensitive), HRR gene mutation FDA approval 26/10/2026 (as reported by ASCO Post). HRR genes include BRCA1 and BRCA2. Source
TalzennaBroader labeltalazoparib page 		BRCA1/2 mutation prostate Approved 2023 Not approved

TALAPRO-2 (HRR-mutated cohort) vs placebo + enzalutamide, 200 vs 199 patients
rPFS not reached vs 13.8 months, HR 0.45 (0.33-0.61)OS 45.1 months vs 31.1 months, HR 0.62 (0.48-0.81)

Serious side effects 30%Stopped for side effects 10%Fatal 1.5%

Trial details and side effects
Patients
HRR gene-mutated mCRPC (NCT03395197)
Most common side effects
anaemia (haemoglobin decreased) 79%, fatigue 49%, nausea 21%, decreased appetite 20%, fractures 14% (197 patients)
Later trial
BRCA-mutated subgroup (71 vs 84 patients, exploratory): rPFS HR 0.20 (0.11-0.36); OS HR 0.48 (0.31-0.75).
Notes
Talazoparib with enzalutamide. Talzenna US label rev. 06/2025.
Source
US label

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
BRCA1/2 mutation 2 2 Phase 4
NRG1 fusion 1 2 Phase 1/2
MSI-H / dMMR 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of enzalutamide.

  1. AstraZeneca 1

Trials

3 of 5 trials shown

  1. Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

    Active, not recruiting Phase 4 AstraZeneca Started 2022Primary completion 2024-10 NCT05457257

    olaparib FDA EUenzalutamide FDAabiraterone FDA EUprednisone

    Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.

    BRCA1/2 mutationMetastatic Castration-resistant Prostate Cancer

  2. Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial

    Recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2025Primary completion 2030-04 NCT06632977

    Valemetostat TosylatecarboplatinCabazitaxelabiraterone FDA EUenzalutamide FDALutetium Lu 177 Vipivotide Tetraxetan

    Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.

    BRCA1/2 mutationCastration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

  3. A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours

    Active, not recruiting Phase 1/2 Cancer Research UK Started 2021Primary completion 2025-11 NCT05057013

    HMBD-001enzalutamide

    Participants with a confirmed existing NRG1 fusion rearrangement or HER amplification will also be considered eligible.

    NRG1 fusionBladder Cancer, Triple Negative Breast Cancer, Castration-resistant Prostate Cancer, Cervical Cancer