Evidence map›Paper›PMID 38627238›Full record

Trial reportJNCI cancer spectrum2024

Derazantinib alone and with atezolizumab in metastatic urothelial carcinoma with activating FGFR aberrations.

Andrea Necchi, Rodryg Ramlau, Alejandro Falcón González, Arvind Chaudhry, Tilman Todenhöfer, Rana Tahbaz, Elisa Fontana, Patrizia Giannatempo, Jean-Laurent Deville, Damien Pouessel and 12 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JNCI cancer spectrum, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04045613 (An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

NCT04045613 phase1 / phase2completednot on this map

An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

TypeinterventionalSponsorBasilea PharmaceuticaRan2019 to 2022Enrolled95ConditionsUrothelial CarcinomaArmsDerazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily+ atezolizumab 1200 mg, Derazantinib 200 mg twice daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily monotherapy (QD)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Review
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 at 14 institutions in 10 countries.

Andrea NecchiDepartment of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy.ORCID 0000-0002-3007-2756
Rodryg RamlauOncology Department, Poznań University of Medical Sciences, Poznań, Poland.
Alejandro Falcón GonzálezDepartment of Medical Oncology, Hospital Universitario Virgen Del Rocio, Sevilla, Spain.
Arvind ChaudhryMedical Oncology Associates, Summit Cancer Centers, Spokane, WA, USA.
Tilman TodenhöferStudienpraxis Urologie, Nürtingen, Germany.
Rana TahbazDepartment of Urology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Elisa FontanaSarah Cannon Research Institute, London, UK.
Patrizia GiannatempoDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Jean-Laurent DevilleFédération de Cancérologie, CHU Timone, Marseille, France.
Damien PouesselDepartment of Medical Oncology and Clinical Research Unit, Institut Claudius Regaud/Institut Universitaire du Cancer de Toulouse (IUCT-Oncopôle), Toulouse, France.
Shinkyo YoonDepartment of Oncology, Asan Medical Center, Seoul, Republic of Korea.
Thomas PowlesBarts Cancer Centre, Barts Health NHS Trust, London, UK.
Mathieu BernatBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.
Manuel HäcklBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.
Michalina MarszewskaBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.
Phil McKernanBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.
Mikael SaulayBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.
Federica ScaleiaBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.
Marc EngelhardtBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.ORCID 0000-0003-2432-0212
Yohann LoriotMedical Oncology Department, Institut Gustave Roussy, Villejuif, France.
Arlene Siefker-RadtkeThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Maria De SantisDepartment of Urology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Basilea Pharmaceutica (Switzerland) · CHAsan Medical Center · KRBarts Health NHS Trust · GBCharité - Universitätsmedizin Berlin · DEFondazione IRCCS Istituto Nazionale dei Tumori · ITHospital Universitario Virgen del Rocío · ESInstitut Claudius Regaud · FRInstitut Gustave Roussy · FRMedical University of Vienna · ATPoznan University of Medical Sciences · PLRocky Mountain Cancer Centers · USSarah Cannon Research Institute · GBThe University of Texas MD Anderson Cancer Center · USVita-Salute San Raffaele University · IT

Funding

Basilea Pharmaceutica
6 · The paper itself

Abstract

backgroundThis Phase 1b/2 study assessed the efficacy in terms of objective response rate (ORR) of the FGFR1/2/3 kinase inhibitor derazantinib as monotherapy or in combination with atezolizumab in patients with metastatic urothelial cancer (mUC) and FGFR1-3 genetic aberrations (FGFR1-3GA).

methodsThis multicenter, open-label study comprised 5 substudies. In Substudies 1 and 5, patients with mUC with FGFR1-3GA received derazantinib monotherapy (300 mg QD in Substudy 1, 200 mg BID in Substudy 5). In Substudy 2, patients with any solid tumor received atezolizumab 1200 mg every 3 weeks plus derazantinib 200 or 300 mg QD. In Substudy 3, patients with mUC harboring FGFR1-3GA received derazantinib 200 mg BID plus atezolizumab 1200 mg every 3 weeks. In Substudy 4, patients with FGFR inhibitor-resistant mUC harboring FGFR1-3GA received derazantinib 300 mg QD monotherapy or derazantinib 300 mg QD plus atezolizumab 1200 mg every 3 weeks.

resultsThe ORR for Substudies 1 and 5 combined was 4/49 (8.2%, 95% confidence interval = 2.3% to 19.6%), which was based on 4 partial responses. The ORR in Substudy 4 was 1/7 (14.3%, 95% confidence interval = 0.4% to 57.9%; 1 partial response for derazantinib 300 mg monotherapy, zero for derazantinib 300 mg plus atezolizumab 1200 mg). In Substudy 2, derazantinib 300 mg plus atezolizumab 1200 mg was identified as a recommended dose for Phase 2. Only 2 patients entered Substudy 3.

conclusionsDerazantinib as monotherapy or in combination with atezolizumab was well-tolerated but did not show sufficient efficacy to warrant further development in mUC. Clinicaltrials.gov NCT04045613, EudraCT 2019-000359-15.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsReceptor, Fibroblast Growth Factor, Type 3AdultAgedAged, 80 and overCarcinoma, Transitional CellFemaleHumansMaleMiddle AgedProtein Kinase InhibitorsReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 2Urinary Bladder NeoplasmsUrologic NeoplasmsAntibodies, Monoclonal, HumanizedatezolizumabFGFR1 protein, humanFGFR3 protein, humanProtein Kinase InhibitorsReceptor, Fibroblast Growth Factor, Type 1Receptor, Fibroblast Growth Factor, Type 2Receptor, Fibroblast Growth Factor, Type 3

Identifiers

PMID38627238
PMCPMC11128722
OpenAlexW4394868958

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.