Evidence map›Paper›PMID 36309837›Full record

Trial reportCancer2023

Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors.

Aung Naing, Alain P Algazi, Gerald S Falchook, Benjamin C Creelan, John Powderly, Seth Rosen, Minal Barve, Niharika B Mettu, Pierre L Triozzi, John Hamm and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in 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 NCT02318277 (A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 27% 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.

NCT02318277 phase1 / phase2completednot on this map

A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)

TypeinterventionalSponsorIncyte CorporationRan2015 to 2020Enrolled176ConditionsSolid Tumors, Head and Neck Cancer, Lung Cancer, UC (Urothelial Cancer)ArmsMEDI4736, INCB024360
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 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 12 institutions in 2 countries.

Aung NaingMD Anderson Cancer Center, University of Texas, Houston, Texas, USA.ORCID 0000-0002-4803-8513
Alain P AlgaziUniversity of California San Francisco, San Francisco, California, USA.
Gerald S FalchookSarah Cannon Research Institute at HealthONE, Denver, Colorado, USA.
Benjamin C CreelanMoffit Cancer Center, Tampa, Florida, USA.
John PowderlyCarolina BioOncology Institute, Huntersville, North Carolina, USA.
Seth RosenHematology Oncology Associates of the Treasure Coast, Port St Lucie, Florida, USA.
Minal BarveMary Crowley Cancer Research, Dallas, Texas, USA.
Niharika B MettuDuke University Medical Center, Durham, North Carolina, USA.
Pierre L TriozziWake Forest University, Winston-Salem, North Carolina, USA.
John HammNorton Cancer Institute, Louisville, Kentucky, USA.
Gongfu ZhouIncyte Corporation, Wilmington, Delaware, USA.
Chris WalkerIncyte Corporation, Wilmington, Delaware, USA.
Zhiwan DongIncyte Corporation, Wilmington, Delaware, USA.
Manish R PatelFlorida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.
Incyte (United States) · USCarolina BioOncology Institute · USDuke Medical Center · USHematology Oncology Associates · USMary Crowley Cancer Research Center · USMoffitt Cancer Center · USNorton Healthcare · USSarah Cannon · USSarah Cannon Research Institute · GBThe University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · USWake Forest University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTargeting programmed cell death protein 1 (PD-1) and indoleamine 2,3-dioxygenase (IDO1) pathways is an appealing option for cancer treatment.

methodsThe open-label, phase 1/2 ECHO-203 study evaluated the safety, tolerability, and efficacy of the IDO1 inhibitor epacadostat in combination with durvalumab, a human anti-PD-L1 monoclonal antibody in adult patients with advanced solid tumors.

resultsThe most common treatment-related adverse events were fatigue (30.7%), nausea (21.0%), decreased appetite (13.1%), pruritus (12.5%), maculopapular rash (10.8%), and diarrhea (10.2%). Objective response rate (ORR) in the overall phase 2 population was 12.0%. Higher ORR was observed in immune checkpoint inhibitor (CPI)-naïve patients (16.1%) compared with patients who had received previous CPI (4.1%). Epacadostat pharmacodynamics were evaluated by comparing baseline kynurenine levels with those on therapy at various time points. Only the 300-mg epacadostat dose showed evidence of kynurenine modulation, albeit unsustained.

conclusionsEpacadostat plus durvalumab was generally well tolerated in patients with advanced solid tumors. ORR was low, and evaluation of kynurenine concentration from baseline to cycle 2, day 1, and cycle 5, day 1, suggested >300 mg epacadostat twice daily is needed to ensure sufficient drug effect. CLINICAL TRIAL INFORMATION: A study of epacadostat (INCB024360) in combination with durvalumab (MEDI4736) in subjects with selected advanced solid tumors (ECHO-203) (NCT02318277).

Indexed as

NeoplasmsNeoplasms, Second PrimaryAdultAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansOximesSulfonamidesAntibodies, MonoclonalepacadostatOximesSulfonamidesdurvalumabepacadostatkynurenineneoplasmsPD-1

Identifiers

PMID36309837
PMCPMC10092291
OpenAlexW4307659025

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.