Evidence map›Paper›PMID 39737542›Full record

Trial reportCancer medicine2025

Phase 3 Study of Talazoparib Plus Enzalutamide Versus Placebo Plus Enzalutamide as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer: TALAPRO-2 Japanese Subgroup Analysis.

Nobuaki Matsubara, Hideaki Miyake, Hiroji Uemura, Atsushi Mizokami, Hiroaki Kikukawa, Takeo Kosaka, Kazuo Nishimura, Motonobu Nakamura, Kazuki Kobayashi, Atsushi Komaru and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03395197 (A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT03395197 phase3active not recruitingnot on this map

A phase 3, randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer

TypeinterventionalSponsorPfizerRan2017 to 2027Enrolled1,054ConditionsmCRPCArmsTalazoparib with enzalutamide, Placebo with enzalutamide
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

15 authors.

Nobuaki MatsubaraNational Cancer Center Hospital East, Kashiwa, Japan.ORCID https://orcid.org/0000-0002-9203-4245
Hideaki MiyakeHamamatsu University School of Medicine, Hamamatsu, Japan.
Hiroji UemuraYokohama City University Medical Center, Yokohama, Japan.
Atsushi MizokamiKanazawa University Hospital, Kanazawa, Japan.
Hiroaki KikukawaKumamoto Medical Center, Kumamoto, Japan.
Takeo KosakaKeio University Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4371-4594
Kazuo NishimuraOsaka International Cancer Institute, Osaka, Japan.
Motonobu NakamuraKyushu Cancer Center, Fukuoka, Japan.
Kazuki KobayashiYokosuka Kyosai Hospital, Yokosuka, Japan.
Atsushi KomaruChiba Cancer Center, Chiba, Japan.
Yuko MoriPfizer R&D Japan, Tokyo, Japan.ORCID https://orcid.org/0000-0003-1919-2463
Shigeyuki ToyoizumiPfizer R&D Japan, Tokyo, Japan.ORCID https://orcid.org/0000-0002-7011-5263
Natsuki HoriPfizer R&D Japan, Tokyo, Japan.ORCID https://orcid.org/0000-0003-4675-3975
Yoshiko UmeyamaPfizer R&D Japan, Tokyo, Japan.ORCID https://orcid.org/0000-0003-4967-0382
Hirotsugu UemuraKindai University Hospital, Osaka, Japan.ORCID https://orcid.org/0000-0002-3665-9523

Funding

Astellas PharmaPfizer
6 · The paper itself

Abstract

backgroundIn TALAPRO-2, the poly(ADP-ribose) polymerase inhibitor talazoparib plus the androgen receptor-signaling inhibitor enzalutamide improved radiographic progression-free survival (rPFS) versus placebo plus enzalutamide (hazard ratio [HR] = 0.63; 95% CI, 0.51-0.78) in molecularly unselected patients with metastatic castration-resistant prostate cancer (mCRPC). We report an exploratory analysis of efficacy, safety, and pharmacokinetics in Japanese patients enrolled in the TALAPRO-2 study.

methodsThe ongoing, multinational, randomized, double-blind, phase 3 TALAPRO-2 study enrolled patients with mCRPC receiving ongoing androgen deprivation therapy. Patients were prospectively assessed for homologous recombination repair (HRR) gene alterations and randomized 1:1 to receive talazoparib or placebo plus enzalutamide once daily. The primary endpoint was rPFS by blinded independent central review (BICR). Secondary endpoints included overall survival, objective response, safety, and pharmacokinetics.

resultsFor the 116 Japanese all-comers patients enrolled in TALAPRO-2, the HR for rPFS was 0.89 (95% CI, 0.45-1.75) for the talazoparib versus placebo arm; among those with HRR-deficient disease, the HR was 0.58 (95% CI, 0.16-2.20). Among patients with BRCA1/2 gene alterations in the HRR-deficient population (n = 10), the HR for rPFS was < 0.01 (95% CI, < 0.01-not reached) for the talazoparib versus placebo arm. In the all-comers population, the objective response rate by BICR was 55% (all complete responses) in the talazoparib arm versus 36% in the placebo arm. The safety profile of talazoparib plus enzalutamide was similar between Japanese patients and the overall all-comers population; no new safety signals were identified. Anemia was the most common grade 3/4 treatment-emergent adverse event (55%) and cause of talazoparib discontinuation (12%). Talazoparib C

conclusionsIn this exploratory analysis, efficacy outcomes with talazoparib plus enzalutamide in Japanese patients in TALAPRO-2 were consistent with those in the overall all-comers population. The safety profile and pharmacokinetics of the combination were similar between Japanese patients and the overall all-comers population.

trial registrationClinicalTrials.gov Identifier: NCT03395197.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBenzamidesNitrilesPhenylthiohydantoinPhthalazinesProstatic Neoplasms, Castration-ResistantAgedAged, 80 and overDouble-Blind MethodEast Asian PeopleHumansJapanMaleMiddle AgedPoly(ADP-ribose) Polymerase InhibitorsProgression-Free SurvivalBenzamidesenzalutamideNitrilesPhenylthiohydantoinPhthalazinesPoly(ADP-ribose) Polymerase InhibitorstalazoparibenzalutamideJapanesemCRPCPARP inhibitorTALAPRO‐2talazoparib

Identifiers

PMID39737542
PMCPMC11686335

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.