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dc.contributor.authorD'Angelo, S. P.
dc.contributor.authorNoujaim, J. C.
dc.contributor.authorThistlethwaite, Fiona C
dc.contributor.authorRazak, A. R. A.
dc.contributor.authorStacchiotti, S.
dc.contributor.authorChow, W. A.
dc.contributor.authorHaanen, J.
dc.contributor.authorChalmers, A. W.
dc.contributor.authorRobinson, S. I.
dc.contributor.authorVan Tine, B. A.
dc.contributor.authorGanjoo, K. N.
dc.contributor.authorJohnson, M. L.
dc.contributor.authorChiou, V. L.
dc.contributor.authorFaitg, T. H.
dc.contributor.authorWoessner, M.
dc.contributor.authorPearce, L.
dc.contributor.authorShalabi, A.
dc.contributor.authorBlay, J. Y.
dc.contributor.authorDemetri, G.
dc.date.accessioned2022-01-11T11:59:46Z
dc.date.available2022-01-11T11:59:46Z
dc.date.issued2021en
dc.identifier.citationD’Angelo SP, Noujaim JC, Thistlethwaite F, Abdul Razak AR, Stacchiotti S, Chow WA, et al. IGNYTE-ESO: A master protocol to assess safety and activity of letetresgene autoleucel (lete-cel; GSK3377794) in HLA-A*02+ patients with synovial sarcoma or myxoid/round cell liposarcoma (Substudies 1 and 2). Vol. 39, Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2021. p. TPS11582–TPS11582.en
dc.identifier.doi10.1200/JCO.2021.39.15_suppl.TPS11582en
dc.identifier.urihttp://hdl.handle.net/10541/624870
dc.description.abstractBackground: Letetresgene autoleucel (lete-cel; GSK3377794) is an autologous T-cell product using a genetically modified T-cell receptor to target cancer cells expressing the cancer testis antigen New-York esophageal squamous cell carcinoma 1 (NY-ESO-1). Lete-cel is currently being investigated alone and in combination in multiple tumor types [1,2]. NY-ESO-1 is expressed in 70‒80% of synovial sarcoma (SS) and 80‒90% of myxoid/round cell liposarcoma (MRCLS) tumors [3,4], suggesting these tumors may be prime lete-cel targets. This master protocol design (IGNYTE-ESO; NCT03967223) enables evaluation of multiple cell therapies in multiple tumor types and treatment stages in separate substudies, beginning with lete-cel in Substudies 1 and 2 for SS and MRCLS. Methods: Substudy 1 is a single-arm study assessing lete-cel in treatment-naïve patients (pts; ie, anthracycline therapy-naïve for metastatic disease) with advanced (metastatic/unresectable) NY-ESO-1+ SS or MRCLS as a first line of therapy (n=10 planned). Substudy 2 is a pivotal, single-arm study assessing lete-cel in pts with NY-ESO-1+ SS or MRCLS who progressed after anthracycline therapy (n=70 planned). Key eligibility criteria are age ≥10 y and NY-ESO-1 and HLA-A*02 positivity. Exclusion criteria include prior NY-ESO-1–specific/gene therapy, allogeneic stem cell transplant, and central nervous system metastases. Screened pts undergo leukapheresis for lete-cel manufacture, lymphodepletion, lete-cel infusion, and follow-up (FU). Long-term FU (15 y) may be done under a separate protocol. The Substudy 2 primary endpoint is overall response rate (ORR) per RECIST v1.1 assessed by central independent review. Substudy 1 is not testing any formal hypotheses; statistical analysis will be descriptive. Substudy 2 is comparing ORR with the historical control assuming at least 90% power with 0.025 one-sided type I error. Secondary endpoints include efficacy (time to/duration of response, disease control rate, progression-free survival), safety (adverse event [AE] frequency/severity, serious AEs, AEs of special interest), and pharmacokinetic (maximum transgene expansion [Cmax], time to Cmax, area under the time curve from zero to time t as data permit). Enrollment began in December 2019. References: 1. Reckamp KL, et al. Ann Oncol 2019;30(Suppl_5):v602–v660. 2. Rapoport A, et al. J Clin Oncol 2020 38:15_suppl, TPS8555. 3. D’Angelo SP, et al. Cancer Discov 2018;8(8):944–957. 4. D’Angelo SP, et al. J Clin Oncol 2018 36:15_suppl, 3005. Funding: GSK. Editorial support was provided by Eithne Maguire, PhD, of Fishawack Indicia, part of Fishawack Health, and funded by GSK. Previously presented at BSG 2021 (P914542).en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1200/JCO.2021.39.15_suppl.TPS11582en
dc.titleIGNYTE-ESO: A master protocol to assess safety and activity of letetresgene autoleucel (lete-cel; GSK3377794) in HLA-A*02+patients with synovial sarcoma or myxoid/round cell liposarcoma (Substudies 1 and 2)en
dc.typeMeetings and Proceedingsen
dc.contributor.departmentMemorial Sloan Kettering Cancer Center, New York, NY;en
dc.identifier.journalJournal of Clinical Oncologyen
dc.description.noteen]


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