Evidence map›Paper›PMID 38452327›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

Brian L Heiss, Elaine Chang, Xin Gao, Tien Truong, Michael H Brave, Erik Bloomquist, Ankit Shah, Salaheldin Hamed, Jeffrey Kraft, Haw-Jyh Chiu and 12 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. FDA Approval Summary: Niraparib plus Abiraterone Acetate Fixed-Dose Combination for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Brian L HeissCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-7858-841X
Elaine ChangCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0001-6255-2853
Xin GaoCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-7383-6453
Tien TruongCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Michael H BraveCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Erik BloomquistMerck & Co, Rahway, NJ.ORCID 0000-0002-5557-3135
Ankit ShahCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-9771-8777
Salaheldin HamedAstellas Pharma, Tokyo, Japan.
Jeffrey KraftCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Haw-Jyh ChiuCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Tiffany K RicksCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
Amy TilleyCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
William F PierceCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-3411-7720
Liuya TangCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Abdelrahmman AbukhdeirAstraZeneca, Cambridge, United Kingdom.
Shyam KalavarCenter for Devices and Radiological Health (CDRH), US Food and Drug Administration, Silver Spring, MD.
Reena PhilipOncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
Shenghui TangCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0437-665X
Richard PazdurOncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-4771-9923
Laleh Amiri-KordestaniCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.ORCID 0000-0002-0056-5437
Paul G KluetzOncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
Daniel L SuzmanCenter for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND

methodsThe approval was based on the HRR gene-mutated (HRRm) population of TALAPRO-2, a randomized, double-blind trial that randomly assigned 1,035 patients with mCRPC to receive enzalutamide with either talazoparib or placebo. Two cohorts enrolled sequentially: an all-comer population (Cohort 1), followed by an HRRm-only population (Cohort 2). The independent primary end points were radiographic progression-free survival (rPFS) per blinded independent central review (BICR) in Cohort 1 (all-comers) and in the combined HRRm population (all HRRm patients from Cohorts 1 and 2). Overall survival (OS) was a key secondary end point.

resultsA statistically significant improvement in rPFS by BICR was demonstrated in both the all-comers cohort and the combined HRRm population, with hazard ratio (HR) of 0.63 (95% CI, 0.51 to 0.78;

conclusionDespite a statistically significant rPFS improvement in the all-comer cohort, FDA did not consider the magnitude of rPFS clinically meaningful in the context of the broad indication, combination treatment, and safety profile. Approval was therefore limited to patients with HRRm mCRPC, for whom there was a statistically significant and clinically meaningful improvement in rPFS and favorable OS results. This represents the first approval for the first-line treatment of patients with HRRm mCRPC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBenzamidesDrug ApprovalMutationNitrilesPhenylthiohydantoinPhthalazinesProstatic Neoplasms, Castration-ResistantRecombinational DNA RepairUnited States Food and Drug AdministrationAgedAged, 80 and overDouble-Blind MethodHumansMaleMiddle AgedBenzamidesNitrilesPhenylthiohydantoinPhthalazines

Identifiers

PMID38452327
PMCPMC11095902

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.