- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
First patient treated in the Phase III ECHO-301 study
23 June 2016 • Author: Victoria White, Digital Content Producer
The first patient has been treated in the ECHO-301 study – a Phase III trial evaluating Incyte’s IDO1 inhibitor, epacadostat, with Merck’s Keytruda (pembrolizumab) as first-line treatment for patients with advanced or metastatic melanoma.
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumour immune response by promoting regulatory T cell generation and blocking effector T cell activation, thereby facilitating tumour growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that reverses tumour-associated immune suppression and restores effective anti-tumour immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone.
Initial data expected in 2018
ECHO-301 is a Phase III randomised, double-blind, placebo-controlled study that will evaluate pembrolizumab in combination with epacadostat or placebo in patients with unresectable or metastatic melanoma. The study will enrol 600 patients, randomised 1:1, who will be stratified by PD-L1 expression (positive versus negative/indeterminate) and BRAF mutation status (BRAF mutant who have received prior BRAF-directed treatment or BRAF mutant with no prior BRAF-directed treatment and BRAF wild type).
The two primary endpoints of the study are progression-free survival and overall survival. Key secondary endpoints include objective response rate, safety and tolerability.
“We are very pleased to treat the first patient in the ECHO-301 study and advance the Phase III programme evaluating epacadostat in combination with pembrolizumab,” said Steven Stein, M.D. Incyte’s Chief Medical Officer. “This trial – the first to test this combination in a pivotal study – is part of the larger ECHO programme evaluating epacadostat, including combination studies with anti-PD-1 and PD-L1 therapies across multiple tumour types.”
Incyte expects initial data from the ECHO-301 study to be available in 2018.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics