Evidence map›Paper›PMID 39083724›Full record

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

Efficacy and Safety of Sacituzumab Govitecan in Patients With Advanced Solid Tumors (TROPiCS-03): Analysis in Patients With Advanced Endometrial Cancer.

Alessandro D Santin, Bradley R Corr, Alexander Spira, Lyndsay Willmott, James Butrynski, Ka Yu Tse, Jilpa Patel, Sabeen Mekan, Tia Wu, Kai-Wen Lin and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
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. It is linked to trial NCT03964727 (A Phase 2 Open-Label Study of Sacituzumab Govitecan), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing 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.

NCT03964727 phase2active not recruitingnot on this map

A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors

TypeinterventionalSponsorGilead SciencesRan2019 to 2026Enrolled227ConditionsMetastatic Solid TumorArmsSacituzumab Govitecan-hziy
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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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

12 authors.

Alessandro D SantinYale School of Medicine, New Haven, CT.ORCID 0000-0003-4724-9738
Bradley R CorrUniversity of Colorado Cancer Center, Aurora, CO.ORCID 0000-0002-6608-2585
Alexander SpiraVirginia Cancer Specialists, Fairfax, VA.ORCID 0000-0003-1303-0447
Lyndsay WillmottHonorHealth Virginia G. Piper Cancer Care Network Biltmore, Phoenix, AZ.
James ButrynskiWillamette Valley Cancer Institute and Research Center, Eugene, OR.
Ka Yu TseSchool of Clinical Medicine, The University of Hong Kong, Hong Kong, China.ORCID 0000-0001-8330-0970
Jilpa PatelGilead Sciences, Inc, Foster City, CA.
Sabeen MekanGilead Sciences, Inc, Foster City, CA.
Tia WuGilead Sciences, Inc, Foster City, CA.
Kai-Wen LinGilead Sciences, Inc, Foster City, CA.ORCID 0000-0003-4821-6727
Peiwen KuoGilead Sciences, Inc, Foster City, CA.ORCID 0009-0003-6993-9040
Ecaterina E DumbravaThe University of Texas MD Anderson Cancer Center, Houston, TX.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

purposePatients with advanced endometrial cancer (EC) who progress on or after platinum-based therapy and immunotherapy have poor prognosis. We report efficacy and safety of sacituzumab govitecan (SG), a trophoblast cell-surface antigen 2 (Trop-2)-directed antibody-drug conjugate, in patients with advanced EC.

methodsTROPiCS-03 (ClinicalTrials.gov identifier: NCT03964727) is a multicohort, open-label, phase II basket study in patients with metastatic solid tumors. Eligible patients in the EC cohort received SG 10 mg/kg once on days 1 and 8 every 3 weeks. Primary end point was objective response rate (ORR) by investigator's assessment per RECIST v1.1. Secondary end points included clinical benefit rate (CBR; complete and partial response, and stable disease ≥6 months), duration of response (DOR), and progression-free survival (PFS) per investigator assessment, overall survival, and safety. Trop-2 expression of archival or baseline tumor specimens was analyzed by immunohistochemistry.

resultsAt data extraction date, 41 patients were enrolled. Median follow-up was 5.8 months (range, 0.7-19.3); median previous therapies was three (range, 1-6); and 85% of patients received previous chemotherapy and immunotherapy. ORR was 22% (95% CI, 11 to 38); CBR was 32% (95% CI, 18 to 48). Median DOR was 8.8 months (95% CI, 2.8 to not estimable); median PFS was 4.8 months (95% CI, 2.8 to 9.8). Trop-2 exploratory analysis was conducted retrospectively for 39 patients. Tumor Trop-2 protein was highly expressed in EC, showing limited correlation with efficacy. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 73% of patients. Study drug discontinuation due to TRAEs was 5%. Two deaths occurred, deemed unrelated to SG.

conclusionFindings from TROPiCS-03 showed encouraging efficacy of SG with a manageable toxicity profile in a heavily pretreated population with advanced EC. Safety findings were consistent with the known SG safety profile.

Indexed as

Antibodies, Monoclonal, HumanizedCamptothecinEndometrial NeoplasmsImmunoconjugatesAdultAgedAged, 80 and overAntigens, NeoplasmCell Adhesion MoleculesFemaleHumansMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedAntigens, NeoplasmCamptothecinCell Adhesion MoleculesImmunoconjugatessacituzumab govitecanTACSTD2 protein, human

Identifiers

PMID39083724
PMCPMC11458108

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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.