Evidence map›Paper›PMID 32060403›Full record

Trial reportLeukemia2020

Single-agent activity of phosphatidylinositol 3-kinase inhibition with copanlisib in patients with molecularly defined relapsed or refractory diffuse large B-cell lymphoma.

Georg Lenz, Eliza Hawkes, Gregor Verhoef, Corinne Haioun, Soon Thye Lim, Dae Seog Heo, Kirit Ardeshna, Geoffrey Chong, Jacob Haaber, Wei Shi and 9 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Leukemia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02391116 (An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma), which is not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT02391116 phase2completednot on this map

An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.

TypeinterventionalSponsorBayerRan2015 to 2018Enrolled67ConditionsDiffuse, Large B-Cell, LymphomaArmsCopanlisib (Aliqopa, BAY80-6946)
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 9 countries.

Georg LenzDepartment of Medicine A, Hematology, Oncology, and Pneumology, University Hospital Münster, Münster, Germany. georg.lenz@ukmuenster.de.
Eliza HawkesEastern Health Clinical School, Monash University, Olivia Newton John Cancer Research and Wellness Centre, Melbourne, VIC, Australia.
Gregor VerhoefUniversity Hospitals Leuven, Leuven, Belgium.
Corinne HaiounLymphoid Malignancies Unit, Groupe Hospitalier Henri Mondor-Albert Chenevier, Creteil, France.
Soon Thye LimNational Cancer Centre Singapore and Duke-NUS Medical School, Singapore, Singapore.
Dae Seog HeoDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Kirit ArdeshnaUniversity College London Hospitals NHS Foundation Trust, London, UK.
Geoffrey ChongBallarat Regional Integrated Cancer Centre, Ballarat, VIC, Australia.
Jacob HaaberDepartment of Hematology, Odense University Hospital, Odense, Denmark.
Wei ShiBayer China, Beijing, China.
Igor GorbatchevskyBayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA.
Susanne LippertPharmaceuticals Division, Bayer AG, Berlin, Germany.
Florian HiemeyerPharmaceuticals Division, Bayer AG, Berlin, Germany.
Paolo PirainoPharmaceuticals Division, Bayer AG, Berlin, Germany.
Georg BeckmannPharmaceuticals Division, Bayer AG, Berlin, Germany.
Carol PeñaBayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA.
Viktoriya BuvayloBayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA.
Barrett H ChildsBayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA.
Gilles SallesHospices Civils de Lyon, Université de Lyon, Centre Hospitalier Lyon-Sud, Service d'hématologie, Lyon, France.ORCID http://orcid.org/0000-0002-9541-8666
Bayer (Germany) · DEBayer (United States) · USBallarat Health Services · AUBayer (China) · CNDuke-NUS Medical School · SGEastern Health · AUHôpital Albert-Chenevier · FROdense University Hospital · DKSeoul National University Hospital · KRUniversité Claude Bernard Lyon 1 · FRUniversity College London Hospitals NHS Foundation Trust · GBUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) have adverse outcomes. We evaluated the efficacy and safety of the phosphatidylinositol 3-kinase inhibitor copanlisib in patients with relapsed/refractory DLBCL and assessed the relationship between efficacy and DLBCL cell of origin (COO; activated B-cell like [ABC] and germinal center B-cell like [GCB]) and other biomarkers. The primary endpoint was objective response rate (ORR) in DLBCL COO subgroups (ABC, GCB, and unclassifiable) and by CD79B mutational status (NCT02391116). Sixty-seven patients received copanlisib (ABC DLBCL, n = 19; GCB DLBCL, n = 30; unclassifiable, n = 3; missing, n = 15). The ORR was 19.4%; 31.6% and 13.3% in ABC and GCB DLBCL patients, respectively. ORR was 22.2%/20.0% for patients with/without CD79B mutations (wild type, n = 45; mutant, n = 9; missing, n = 13). Overall median progression-free survival and duration of response were 1.8 and 4.3 months, respectively. Adverse events included hypertension (40.3%), diarrhea (37.3%), and hyperglycemia (32.8%). Aberrations were detected in 338 genes, including BCL2 (53.7%) and MLL2 (53.7%). A 16-gene signature separating responders from nonresponders was identified. Copanlisib treatment demonstrated a manageable safety profile in patients with relapsed/refractory DLBCL and a numerically higher response rate in ABC vs. GCB DLBCL patients.

Indexed as

AdultAgedAged, 80 and overCD79 AntigensFemaleHigh-Throughput Nucleotide SequencingHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedMutationPhosphoinositide-3 Kinase InhibitorsPyrimidinesQuinazolinesRecurrenceCD79 AntigensCD79B protein, humancopanlisibPhosphoinositide-3 Kinase InhibitorsPyrimidinesQuinazolines

Identifiers

PMID32060403
PMCPMC7387311
OpenAlexW3005797416

What OpenQuestion holds

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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.