Evidence map›Paper›PMID 37861461›Full record

ArticleCancer discovery2024

Xaluritamig, a STEAP1 × CD3 XmAb 2+1 Immune Therapy for Metastatic Castration-Resistant Prostate Cancer: Results from Dose Exploration in a First-in-Human Study.

William K Kelly, Daniel C Danila, Chia-Chi Lin, Jae-Lyun Lee, Nobuaki Matsubara, Patrick J Ward, Andrew J Armstrong, David Pook, Miso Kim, Tanya B Dorff and 11 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Cancer discovery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04221542 (A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer), which is not on this map. Cited by 73 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 3 pooled it
20.4field-weighted citation impact, top 1% of its field
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.

NCT04221542 phase1recruitingnot on this map

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

TypeinterventionalSponsorAmgenRan2020 to 2032Enrolled479ConditionsProstate CancerArmsAMG 509, Abiraterone, Enzalutamide
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 3 syntheses or guidelines pooled it, 79 citations in OpenAlex.

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13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 8 countries.

William K Kelly *Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania.ORCID 0000-0003-2629-672X
Daniel C Danila *Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-7647-0741
Chia-Chi LinNational Taiwan University Hospital, Taipei, Taiwan.ORCID 0000-0002-2573-5789
Jae-Lyun LeeAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.ORCID 0000-0002-9420-7162
Nobuaki MatsubaraNational Cancer Center Hospital East, Chiba, Japan.ORCID 0000-0002-9203-4245
Patrick J WardSarah Cannon Research Institute, Nashville, Tennessee.ORCID 0000-0002-7800-4840
Andrew J ArmstrongDuke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, North Carolina.ORCID 0000-0001-7012-1754
David PookMonash Health, Clayton, Victoria, Australia.ORCID 0000-0002-1744-3022
Miso KimSeoul National University Hospital, Seoul, South Korea.ORCID 0000-0002-4064-4199
Tanya B DorffCity of Hope, Duarte, California.ORCID 0000-0001-5990-298X
Stefanie FischerDepartment of Medical Oncology and Hematology, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.ORCID 0000-0001-9609-3640
Yung-Chang LinDepartment of Gastroenterology and Hepatology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.ORCID 0000-0002-2084-5348
Lisa G HorvathChris O'Brien Lifehouse, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0001-6842-9223
Christopher SumeySanford Cancer Center, Sioux Falls, South Dakota.ORCID 0000-0002-9288-2236
Zhao YangAmgen Inc., Thousand Oaks, California.ORCID 0000-0002-1199-1052
Gabor JuridaAmgen Inc., Thousand Oaks, California.ORCID 0009-0000-8003-1269
Kristen M SmithAmgen Inc., South San Francisco, California.ORCID 0000-0003-0960-0937
Jamie N ConnarnAmgen Inc., South San Francisco, California.ORCID 0000-0001-7112-7357
Hweixian L PennyAmgen Inc., Thousand Oaks, California.ORCID 0009-0000-3212-0275
Julia StieglmaierAmgen Research (Munich) GmbH, Munich, Germany.ORCID 0009-0009-7035-5855
Leonard J ApplemanUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania.ORCID 0000-0003-4951-7388
Amgen (United States) · USSarah Cannon · USVistaGen Therapeutics (United States) · USAmgen (Germany) · DEAvera Health · USChang Gung Memorial Hospital · TWChris O’Brien Lifehouse · AUCity Of Hope National Medical Center · USMemorial Sloan Kettering Cancer Center · USMonash Health · AUNational Cancer Center Hospital East · JPNational Taiwan University Hospital · TWProstate Cancer Research · GBSeoul National University Hospital · KRUniversity of St.Gallen · CHUniversity of Ulsan · KRUPMC Hillman Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Xaluritamig (AMG 509) is a six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted T-cell engager designed to facilitate lysis of STEAP1-expressing cancer cells, such as those in advanced prostate cancer. This first-in-human study reports monotherapy dose exploration for patients with metastatic castration-resistant prostate cancer (mCRPC), primarily taxane pretreated. Ninety-seven patients received ≥1 intravenous dose ranging from 0.001 to 2.0 mg weekly or every 2 weeks. MTD was identified as 1.5 mg i.v. weekly via a 3-step dose. The most common treatment-related adverse events were cytokine release syndrome (CRS; 72%), fatigue (45%), and myalgia (34%). CRS occurred primarily during cycle 1 and improved with premedication and step dosing. Prostate-specific antigen (PSA) and RECIST responses across cohorts were encouraging [49% PSA50; 24% objective response rate (ORR)], with greater frequency at target doses ≥0.75 mg (59% PSA50; 41% ORR). Xaluritamig is a novel immunotherapy for prostate cancer that has shown encouraging results supporting further development. SIGNIFICANCE: Xaluritamig demonstrated encouraging responses (PSA and RECIST) compared with historical established treatments for patients with late-line mCRPC. This study provides proof of concept for T-cell engagers as a potential treatment for prostate cancer, validates STEAP1 as a target, and supports further clinical investigation of xaluritamig in prostate cancer. See related commentary by Hage Chehade et al., p. 20. See related article by Nolan-Stevaux et al., p. 90. This article is featured in Selected Articles from This Issue, p. 5.

Indexed as

Prostate-Specific AntigenProstatic Neoplasms, Castration-ResistantAntigens, NeoplasmHumansImmunotherapyMaleOxidoreductasesTreatment OutcomeAntigens, NeoplasmOxidoreductasesProstate-Specific AntigenSTEAP1 protein, human

Identifiers

PMID37861461
PMCPMC10784743
OpenAlexW4387798677

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.