Evidence map›Paper›PMID 33852104›Full record

ArticleInvestigational new drugs2021

A phase 1a/1b trial of CSF-1R inhibitor LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid tumors.

Gerald S Falchook, Marc Peeters, Sylvie Rottey, Luc Y Dirix, Radka Obermannova, Jonathan E Cohen, Ruth Perets, Ronnie Shapira Frommer, Todd M Bauer, Judy S Wang and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02718911 (A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination With Durvalumab), which is not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 6% 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.

NCT02718911 phase1completednot on this map

A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination With Durvalumab (MEDI4736) or Tremelimumab in Patients With Advanced Solid Tumors

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2018Enrolled72ConditionsSolid TumorArmsLY3022855, Durvalumab, Tremelimumab
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 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

16 authors at 14 institutions in 5 countries.

Gerald S FalchookDrug Development Unit, Sarah Cannon Research Institute at HealthONE, 1800 Williams St Ste 300, Denver, CO, USA. Gerald.Falchook@SarahCannon.com.
Marc PeetersDepartment of Oncology, University Antwerpen, Universitair Ziekenhuis Antwerpen, Drie Eikenstraat, Edegem, Belgium.
Sylvie RotteyDrug Research Unit, Universitair Ziekenhuis Gent, Corneel Heymanslaan, Ghent, Belgium.
Luc Y DirixDepartment of Medical Oncology, GZA Sint Augustinus, Oosterveldlaan, Wilrijk, Belgium.
Radka ObermannovaComprehensive Cancer Care Department - Faculty of Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
Jonathan E CohenDepartment of Oncology, Sharett Institute of Oncology, Hadassah Medical Center, Jerusalem, Israel.
Ruth PeretsDepartment of Oncology, Clinical Research Institute at Rambam, Rambam Medical Center, Haifa, Israel.
Ronnie Shapira FrommerThe Ella Institute for Immuno-Oncology, Sheba Medical Center, Oncology Institute, Tel Hashomer, Ramat Gan, Israel.
Todd M BauerDepartment of Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA.
Judy S WangHematologic Oncology, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA.
Richard D CarvajalDepartment of Medicine, Division of Hematology/Oncology, Columbia University, College of Physicians and Surgeons, New York, NY, USA.
Joshua SabariDepartment of Medicine,Medical Oncology, NYU Langone Health, New York, NY, USA.
Sonya ChapmanEli Lilly and Company, Windlesham, Surrey, UK.
Wei ZhangEli Lilly and Company, Indianapolis, IN, USA.
Boris CalderonEli Lilly and Company, Indianapolis, IN, USA.
Daniel A PetersonEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USAntwerp University Hospital · BEColumbia University · USEli Lilly (United Kingdom) · GBGhent University Hospital · BEGZA Ziekenhuizen Campus Sint-Augustinus · BEHadassah Medical Center · ILHealthONE · USMasaryk Memorial Cancer Institute · CZNYU Langone Health · USSarah Cannon · USSheba Medical Center · ILTechnion – Israel Institute of Technology · ILTennessee Oncology · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background LY3022855 is a recombinant, immunoglobulin, human monoclonal antibody targeting the colony-stimulating factor-1 receptor. This phase 1 trial determined the safety, pharmacokinetics, and antitumor activity of LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid cancers who had received standard anti-cancer treatments. Methods In Part A (dose-escalation), patients received intravenous (IV) LY3022855 25/50/75/100 mg once weekly (QW) combined with durvalumab 750 mg once every two weeks (Q2W) IV or LY3022855 50 or 100 mg QW IV with tremelimumab 75/225/750 mg once every four weeks. In Part B (dose-expansion), patients with non-small cell lung cancer (NSCLC) or ovarian cancer (OC) received recommended phase 2 dose (RP2D) of LY3022855 from Part A and durvalumab 750 mg Q2W. Results Seventy-two patients were enrolled (median age 61 years): Part A = 33, Part B = 39. In Part A, maximum tolerated dose was not reached, and LY3022855 100 mg QW and durvalumab 750 mg Q2W was the RP2D. Four dose-limiting equivalent toxicities occurred in two patients from OC cohort. In Part A, maximum concentration, area under the concentration-time curve, and serum concentration showed dose-dependent increase over two cycles of therapy. Overall rates of complete response, partial response, and disease control were 1.4%, 2.8%, and 33.3%. Treatment-emergent anti-drug antibodies were observed in 21.2% of patients. Conclusions LY3022855 combined with durvalumab or tremelimumab in patients with advanced NSCLC or OC had limited clinical activity, was well tolerated. The RP2D was LY3022855 100 mg QW with durvalumab 750 mg Q2W. ClinicalTrials.gov ID: NCT02718911 (Registration Date: May 3, 2011).

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugFemaleHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsdurvalumabReceptors, Colony-Stimulating FactortremelimumabAdvanced solid cancerCSF-1CSF-1R inhibitorLY3022855NSCLCOvarian cancer

Identifiers

PMID33852104
OpenAlexW3155223647

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.