Evidence map›Paper›PMID 37662520›Full record

ArticleEClinicalMedicine2023

Parsaclisib, a PI3Kδ inhibitor, in relapsed and refractory follicular lymphoma (CITADEL-203): a phase 2 study.

Marek Trněný, Abraham Avigdor, Matthew S McKinney, Shankara Paneesha, Björn E Wahlin, John S Hrom, David Cunningham, Nicholas Morley, Miguel Canales, Mariana Bastos-Oreiro and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03126019 (A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

NCT03126019 phase2completednot on this map

A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

TypeinterventionalSponsorIncyte CorporationRan2018 to 2024Enrolled126ConditionsLymphomaArmsParsaclisib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. 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

17 authors at 14 institutions in 7 countries.

Marek TrněnýFirst Department of Medicine - Hematology, Charles University General Hospital, Prague, Czech Republic.
Abraham AvigdorInstitute of Hematology, Sheba Medical Center, Ramat Gan, Israel.
Matthew S McKinneyDivision of Hematologic Malignancies and Cellular Therapy, Department of Medicine, Duke Cancer Institute, Durham, NC, USA.
Shankara PaneeshaDepartment of Haematology & Stem Cell Transplantation, Birmingham Heartlands Hospital, Birmingham, UK.
Björn E WahlinKarolinska Institutet, Department of Medicine, Huddinge, and Karolinska University Hospital, Unit for Hematology, Stockholm, Sweden.
John S HromForrest General Hospital and Hattiesburg Clinic of Hematology and Oncology, Hattiesburg, MS, USA.
David CunninghamRoyal Marsden Hospital, NHS Foundation Trust, London and Surrey, UK.
Nicholas MorleySheffield Teaching Hospital, NHS Foundation Trust, Sheffield and London, UK.
Miguel CanalesHospital Universitario La Paz, Madrid, Spain.
Mariana Bastos-OreiroHematology Department, Hospital General Universitario Gregorio Marañón (IiSGM), Madrid, Spain.
David BeladaFourth Department of Internal Medicine - Hematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.
Liliana DevizziDivision of Hemathology and Stem Cell Transplantation, IRCCS Istituto Nazionale Tumori, Milan, Italy.
Fred ZhengIncyte Corporation, Wilmington, DE, USA.
Douglas J DeMariniIncyte Corporation, Wilmington, DE, USA.
Wei JiangIncyte Corporation, Wilmington, DE, USA.
Ping JiangIncyte Corporation, Wilmington, DE, USA.
Ryan C LynchUniversity of Washington School of Medicine, Fred Hutch Cancer Center, Seattle, WA, USA.
Incyte (United States) · USCharles University · CZDuke Medical Center · USFred Hutch Cancer Center · USHattiesburg Clinic · USHeartlands Hospital · GBHospital General Universitario Gregorio Marañón · ESHospital Universitario La Paz · ESKarolinska University Hospital · SERoyal Marsden NHS Foundation Trust · GBSheffield Teaching Hospitals NHS Foundation Trust · GBTel Aviv University · ILTumori Foundation · USUniversity Hospital Hradec Králové · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Parsaclisib, a potent and highly selective PI3Kδ inhibitor, has shown clinical benefit in patients with relapsed or refractory (R/R) B-cell malignancies. This phase 2 study (CITADEL-203; NCT03126019, EudraCT 2017-001624-22) assessed efficacy and safety of parsaclisib monotherapy in patients with R/R follicular lymphoma (FL). Methods: Patients ≥18 years of age with histologically confirmed R/R FL (grade 1-3a) and prior treatment with ≥2 systemic therapies received parsaclisib 20 mg once daily (QD) for 8 weeks then parsaclisib 20 mg once weekly (weekly dosing group [WG]) or parsaclisib 20 mg QD for 8 weeks then parsaclisib 2.5 mg QD (daily dosing group [DG]); DG was selected for further assessment. Primary endpoint was objective response rate (ORR). Findings: At data cut-off (January 15, 2021), 126 patients had been treated (WG: n = 23; DG: n = 103). ORR (95% confidence interval [CI]) was 77.7% (68.4-85.3) with a complete response rate (95% CI) of 19.4% (12.3-28.4) in DG; median (95% CI) duration of response was 14.7 months (10.4-not estimable [NE]), median progression-free survival was 15.8 months (11.0-NE), and median overall survival was not reached. The most common any-grade treatment-emergent adverse events (TEAEs) among all treated patients included diarrhoea (n = 48, 38.1%), nausea (n = 31, 24.6%), and cough (n = 28, 22.2%); the most common grade ≥3 TEAEs were diarrhoea (n = 15, 11.9%), neutropenia (n = 13, 10.3%), and colitis (n = 7, 5.6%). Dose interruption, reduction, and discontinuation from TEAEs occurred in 46.8% (n = 59), 17.5% (n = 22), and 23.8% (n = 30) of patients, respectively. Interpretation: Treatment with parsaclisib demonstrated rapid and durable responses, and a manageable safety profile in patients with R/R FL. Funding: Incyte Corporation.

Indexed as

Follicular lymphomaNon-Hodgkin lymphomaParsaclisibPI3K inhibitor

Identifiers

PMID37662520
PMCPMC10469382
OpenAlexW4385975290

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.