Evidence map›Paper›PMID 38986210›Full record

Trial reportESMO open2024

Open-label, dose-escalation FIGHT-101 study of pemigatinib combined with targeted therapy, chemotherapy, or immunotherapy in patients with advanced malignancies.

M Saleh, M Barve, V Subbiah, K P Papadopoulos, D Morgensztern, N B Mettu, S Roychowdhury, I Spanggaard, M L Veronese, C Tian and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02393248 (A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT02393248 phase1 / phase2terminatednot on this map

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)

TypeinterventionalSponsorIncyte CorporationRan2015 to 2021Enrolled201ConditionsLung Cancer, Solid Tumor, Gastric Cancer, Urothelial CancerArmsPemigatinib, Gemcitabine, Pembrolizumab, Docetaxel, Trastuzumab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
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  8. 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

12 authors.

M SalehO'Neal Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, USA; Department of Hematology and Oncology, Aga Khan University, Nairobi, Kenya. Electronic address: mansoor.saleh@aku.edu.
M BarveMary Crowley Cancer Research Center, Dallas.
V SubbiahSarah Cannon Research Institute, Nashville.
K P PapadopoulosSTART San Antonio, San Antonio.
D MorgenszternDivision of Oncology, Washington University School of Medicine, St. Louis.
N B MettuDivision of Medical Oncology, Duke University Medical Center, Durham.
S RoychowdhuryThe Ohio State University Comprehensive Cancer Center, Columbus, USA.
I SpanggaardDepartment of Oncology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
M L VeroneseIncyte International Biosciences Sàrl, Morges, Switzerland.
C TianIncyte Corporation, Wilmington.
I M SilvermanIncyte Corporation, Wilmington.
M GutierrezJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPemigatinib is an oral, potent, selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor. FIGHT-101, a three-part, open-label, first-in-human, phase I/II study (NCT02393248), evaluated pemigatinib in patients with advanced solid tumors. In parts 1 and 2, pemigatinib monotherapy had a manageable safety profile and antitumor activity in FGFR-altered tumors. Part 3 (pemigatinib combination therapies) results are presented here. PATIENTS AND

methodsPatients received 9, 13.5, or 20 mg oral once-daily pemigatinib on continuous or intermittent schedules with gemcitabine and cisplatin (pemi/gem/cis), docetaxel (pemi/doc), trastuzumab (pemi/tras), pembrolizumab (pemi/pembro), or retifanlimab (pemi/reti) irrespective of whether the tumor was confirmed as FGFR altered. Primary endpoints were safety and pharmacodynamics. Secondary endpoints were investigator-assessed tumor objective response rates (ORRs) and pharmacokinetics (PK).

resultsOf 65 enrolled patients (pemi/gem/cis, n = 8; pemi/doc, n = 7; pemi/tras, n = 6; pemi/pembro, n = 26; pemi/reti, n = 18), all discontinued. Treatment-emergent adverse events (TEAEs) were generally consistent with individual drug AEs. Serious and grade ≥3 TEAEs occurred in 0%-85.7% and 33.3%-100.0% of patients across treatment groups, respectively. All pemigatinib combinations demonstrated steady-state PK comparable to monotherapy. Pharmacodynamic effects in all pemigatinib combinations, except pemi/gem/cis, were consistent with monotherapy. Less inhibition of FGFR2α phosphorylation was observed with this combination. ORRs (95% confidence interval) were 37.5% [8.5% to 75.5% (pemi/gem/cis)], 14.3% [0.4% to 57.9% (pemi/doc)], 0% (pemi/tras), 26.9% [11.6% to 47.8% (pemi/pembro)], and 11.1% [1.4% to 34.7% (pemi/reti)]. All groups had instances of tumor shrinkage. ORRs in assessable patients with FGFR rearrangements and mutations were 50% and 33%, respectively.

conclusionsPemigatinib combination therapy showed no unexpected toxicities. PK and pharmacodynamics were mostly consistent with pemigatinib monotherapy. Pemi/gem/cis (37.5%) and pemi/pembro (26.9%) had the highest ORR; most responders had FGFR alterations.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoplasmsPyrimidinesAdultAgedFemaleHumansImmunotherapyMaleMiddle AgedMolecular Targeted TherapyMorpholinesPyrrolesReceptors, Fibroblast Growth FactorMorpholinespemigatinibPyrimidinesPyrrolesReceptors, Fibroblast Growth Factorclinical trialfibroblast growth factor receptorpemigatinibphase I/IIsolid tumortargeted therapy

Identifiers

PMID38986210
PMCPMC11295983

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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.