Evidence map›Paper›PMID 36797356›Full record

Trial reportBritish journal of cancer2023

A Phase 1/2 study of the PD-L1 inhibitor, BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours.

Jayesh Desai, Peter Fong, Victor Moreno, Sophia Frentzas, Tarek Meniawy, Ben Markman, Mark Voskoboynik, Tahmina Rahman, Nageshwar Budha, John Wu and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03379259 (Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.2field-weighted citation impact, top 8% 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.

NCT03379259 phase1 / phase2terminatednot on this map

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

TypeinterventionalSponsorBeiGeneRan2017 to 2020Enrolled39ConditionsAdvanced Solid TumorsArmsBGB-A333, BGB-A317
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 14 citations in OpenAlex.

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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

14 authors at 8 institutions in 4 countries.

Jayesh DesaiPeter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Jayesh.Desai@petermac.org.ORCID http://orcid.org/0000-0003-4246-9344
Peter FongThe University of Auckland and Auckland City Hospital, Auckland, New Zealand.
Victor MorenoSTART Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain.ORCID http://orcid.org/0000-0001-6099-4236
Sophia FrentzasMonash Health, Clayton, VIC, Australia.
Tarek MeniawyLinear Clinical Research and University of Western Australia, Nedlands, WA, Australia.
Ben MarkmanMonash Health, Clayton, VIC, Australia.
Mark VoskoboynikMonash University, Clayton, VIC, Australia.
Tahmina RahmanBeiGene USA, Inc., San Mateo, CA, USA.
Nageshwar BudhaBeiGene USA, Inc., San Mateo, CA, USA.
John WuBeiGene USA, Inc., San Mateo, CA, USA.
Jin MarlowBeiGene USA, Inc., San Mateo, CA, USA.
Silu YangBeiGene (Beijing) Co., Ltd., Beijing, China.
Emiliano CalvoSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.
Juan Martin-LiberalCatalan Institute of Oncology (ICO), Hospitalet, Barcelona, Spain.
Monash Health · AUBeiGene (China) · CNHospital Universitario Fundación Jiménez Díaz · ESInstitut Català d'Oncologia · ESThe Alfred Hospital · AUThe Royal Melbourne Hospital · AUThe University of Western Australia · AUUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients do not respond or eventually relapse on treatment with programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) checkpoint inhibitors due to secondary or acquired resistance; therefore, there is a need to investigate novel PD-1/PD-L1 inhibitors.

methodsThis open-label, non-randomised study investigated the safety and anti-tumour activity of BGB-A333, a PD-L1 inhibitor, alone and in combination with tislelizumab in patients with advanced solid tumours with progression during/after standard therapy. The primary objectives were to determine the recommended Phase 2 dose (RP2D), safety and tolerability for BGB-A333 alone and in combination with tislelizumab (Phase 1a/1b) and to determine the overall response rate (ORR) with BGB-A333 plus tislelizumab (Phase 2).

resultsOverall, 39 patients across Phase 1a (N = 15), 1b (N = 12) and 2 (N = 12) were enroled. In Phase 1a, an RP2D of 1350 mg was determined. In Phase 1a and 1b/2, serious treatment-emergent adverse events (TEAEs) were reported in five and eight patients, respectively. Two patients experienced TEAEs that led to death. In Phase 2, the ORR was 41.7% (n = 5/12; 95% confidence interval: 15.17%, 72.33%).

conclusionsTEAEs reported with BGB-A333 were consistent with other PD-L1 inhibitors. Encouraging preliminary anti-tumour activity was observed with BGB-A333 in combination with tislelizumab. CLINICAL

trial registrationNCT03379259.

Indexed as

B7-H1 AntigenImmune Checkpoint InhibitorsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansNeoplasm Recurrence, LocalProgrammed Cell Death 1 ReceptorAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanImmune Checkpoint InhibitorsProgrammed Cell Death 1 Receptortislelizumab

Identifiers

PMID36797356
PMCPMC10070264
OpenAlexW4321083638

What OpenQuestion holds

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LicenceCC BY
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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.