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Safety and Activity of Autologous T Cells with Enhanced D’Angelo SP1, Blay J-Y2, Chow W3, Demetri G4, Thistlethwaite F5, Sen S6, Razak A7, Safety and Activity of Autologous T Cells With Enhanced NY-ESO-1–Specific T-Cell Receptor Haanen J8, Noujaim J9, Johnson ML10, Laetsch TW11, Chiou VL12, Pearce L12, Faitg TH12, Ji R12, Johnson LA12, Shalabi A12, Thornton K4, Mackall C13, Van Tine BA14 (GSK3377794) in HLA-A*02+ Previously-Treated and -Untreated Patients With Advanced 1Memorial Sloan Kettering Cancer Center, New York, NY, USA; 2Département de Cancérologie Médicale, Centre Léon Bérard, Lyon, France; 3City of Hope Comprehensive Cancer Center, Duarte, CA, USA; 4Dana-Farber Cancer Institute and Ludwig Center at Harvard Medical School, Boston, MA, USA; 5The Christie NHS Foundation Trust and University of Manchester, Manchester, UK; 6Sarah Cannon Research Metastatic/Unresectable Synovial Sarcoma: A Master Protocol Study Design (IGNYTE-ESO) Institute, Denver, CO, USA; 7Princess Margaret Cancer Centre and Mount Sinai Hospital, Toronto, ON, Canada; 8Plesmanlaan 121, Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, Netherlands; 9Institut D’Hématologie-Oncologie, Hôpital Maisonneuve-Rosemont, Montreal, Poster No. 459 QC, Canada; 10Sarah Cannon Research Institute, Nashville, TN, USA; 11University of Texas Southwestern Medical Center, Dallas, TX, USA; 12GlaxoSmithKline, Philadelphia, PA, USA; 13Stanford University, Palo Alto, CA, USA; 14Washington University in St. Louis, St. Louis, MO, USA Background Study design Unmet need This trial (IGNYTE-ESO; NCT03967223) has a Master Protocol design consisting of a The protocol may be amended to include additional substudies to investigate other NY-ESO-1+ core protocol and allowing for multiple independent substudies to investigate the activity or LAGE-1a+ positive tumor types and other NY-ESO-1–specific T cells, potentially in combination Response rates to anthracycline-based chemotherapy, a first-line treatment in Key inclusion criteria Key exclusion criteria advanced metastatic/unresectable synovial sarcoma (SS), are low (<30%) and of NY-ESO-1–specific T cells in multiple tumor types; overall sample size is not fixed. with other agents often not durable1 The first 2 substudies are non-randomized, single-arm investigations of GSK3377794 in patients with metastatic SS Master Protocol design (IGNYTE-ESO) ■ ≥10 years of age ■ Central nervous system metastases ■ Measurable disease ■ Clinically significant systemic illness Study rationale Substudy 1 ■ Positive for HLA-A*02:01, ■ Prior gene therapy with integrating vector is a member of the cytoplasmic cancer/testis family of tumor antigens Substudy 1Substudy 2 HLA-A*02:05 ± HLA-A*02:06 or NY-ESO-1–specific T cells, vaccine, or NY-ESO-1 Advanced Previously HLA-A*02 GSK3377794 detectable in many cancer types, including SS ■ Tumor expression of NY-ESO-1 targeting antibody Previously untreated patients who: Previously treated patients who: metastatic or untreated participants • SS comprises ~5%–10% of soft-tissue sarcomas2 unresectable SS with NY-ESO-1 ■ Adequate organ function ■ Prior autoimmune disease or allogeneic ■ • Previous clinical studies using adoptively transferred T cells against NY-ESO-1 positive tumors Long-term follow-up and safety ECOG performance status 0–1 hematopoietic stem-cell transplant have reported objective responses in 40%–60% of patients with HLA-A*02+ HLA-A*02:01 HLA-A*02:01 bearing NY-ESO-1+ SS3–5 have ≥1 have ≥1 Substudy 2 Genetically engineered NY-ESO-1–specific T cells (NY-ESO-1 T cells; 1 HLA-A*02:05 positive 1 HLA-A*02:05 positive Advanced Progressed HLA-A*02 GSK3377794 GSK3377794) are autologous CD4+ and CD8+ T cells transduced with a self- allele allele metastatic or post chemo participants inactivating lentiviral vector to express an affinity-enhancedNY-ESO-1–specific TCR HLA-A*02:06 HLA-A*02:06 unresectable SS with NY-ESO-1 Unlike CAR-T cells that recognize cell surface proteins, TCRs can recognize positive tumors antigenic epitopes of intracellular proteins that are processed and presented on the Primary Endpoints Secondary Endpoints Exploratory Endpoints surface of the cancer cell in the context of HLA have NY-ESO-1+ advanced have NY-ESO-1+ advanced Potential additional substudy ■ ■ Time to and duration ■ Correlation of T-cell persistence 2 metastatic or unresectable SS 2 metastatic or unresectable SS Other tumor NY-ESO-1–specific Substudy 1: Ongoing Phase I and II trials are evaluating GSK3377794 as a first-line and second- Overall response rate per of response with safety, clinical response, line therapy for treatment of hematologic malignancies and solid tumors, including SS types T cells alone or RECIST v1.1 assessed ■ and phenotype of infused T cells have progressed following combined with Disease control rate by investigators ■ ■ anthracycline-based other agents Progression-free survival Relationship between 3 ■ chemotherapy Substudy 2: ■ Overall survival (Substudy 2) antigen expression and Mechanism of action Potential additional substudy treatment response Overall response rate per ■ Adverse events, including Other tumor NY-ESO-1–specific RECIST v1.1 assessed by serious adverse events ■ Potential immune response to TCR engineered NY-ESO-1–specific T cells TCR engineered NY-ESO-1–specific types T cells alone or independent central review NY-ESO-1 is expressed in various ■ Presence and titers of GSK3377794 (Substudy 1) Patient’s T cell combined with malignancies, but is absent in TCR TCR (N=10) (N=55 planned to ensure that ≥45 receive treatment) anti-GSK3377794 antibodies ■ Impact on quality of life and β - chain α - chain other agents healthy, normal, adult tissue, with over time (Substudy 2) daily functioning the exception of germ cells of the Alpha Beta chain chain Constant region adult testis Enhanced TCR Eligibility Leukapheresis Lymphodepletion, Long-term Follow-up • Because testis germ cells α CDR Variable PART PART PART PART 6 loops region 1 2 3 4 CDRs have low HLA expression, β CDR screening & Manufacture Treatment & Follow-up (Study 208750) off-target side effects would loops Peptide be expected to be limited when targeting NY-ESO-1 β 2m HLA Manufacturing of NY-ESO-1 is one of the most NY-ESO-1 T cells immunogenic proteins described in HLA – A2 GSK3377794 human cancer, based on its capacity to elicit simultaneous antibody and Cancer cell CD8+ T-cell responses in vivo Target Expression Leukapheresis Treatment Lymphodepletion GSK3377794 Follow- Screening Eligibility Screening Eligibility Cy × 2 days Summary Leukapheresis Infusion up Long-term Follow-up HLA-A*02* Confirmed Flu × 4 days • GSK3377794 has shown encouraging clinical activity in earlier clinical trials and NY-ESO-1 28 days prior to apheresis Days -13 to -8 Days -7 to -4 Day 1 Up to 15 years after GSK3377794 infusion • This larger clinical trial is being initiated to establish and further discern Fludarabine Response evaluation: the efficacy and safety of GSK3377794 in patients with biomarker-selected 30 mg/m2/day x 4 days RECIST 1.1 metastatic SS (Day -7 to -4) Primary endpoints: ORR This innovative Master Protocol study design permits evaluation of Cyclophosphamide • 2 Secondary endpoints: NY-ESO-1– specific T cells in other NY-ESO-1+ tumor types in HLA-A*02:01, 1800 mg/m /day x 2 days (Day -5 to -4) TTR, DOR, DCR, PFS, HLA-A*02:05, ± HLA-A*02:06 allele positive patients within separate substudies OS, safety • Enrollment began in December 2019 Abbreviations References Acknowledgments Disclosures Ethics approval statement For questions, please contact: [email protected] CAR-T, chimeric antigen receptor T cells; Study funded by GlaxoSmithKline (GSK; 208467; NCT03967223). Medical writing assistance was provided by SPDA: consulting or advisory role: Immune design, GSK; consulting or advisory role, travel, accommodations, expenses: Adaptimmune; consulting or advisory role, travel, accommodations, expenses, research funding (to institution): EMD Serono, Nektar; consulting or advisory role, research funding (to institution): Amgen, Merck, Incyte; research funding (to institution): Bristol-Myers Squibb (BMS), Deciphera. J-YB: consulting or advisory role: This Master Protocol (IGNYTE-ESO) will be conducted 1. Vlenterie M, et al. Eur J Cancer 2016;58:62–72. Deciphera, Blueprint Medicines, Bayer; leadership: Innate Pharma; travel, accommodations, expenses, honoraria: Roche, AstraZeneca (AZ), MSD, BMS; research funding (to institution): GSK, Novartis, Bayer; consulting or advisory role, travel, accommodations, expense, research funding (to institution): Roche, PharmaMar. WC: honoraria, travel, accommodations, expenses: GSK; consulting or advisory role: Advenchen Laboratories. GD: consulting CDR, complementarity-determining region; Fiona Woodward, PhD, (original presentation) and Gemma Corr, DPhil, (encore presentation) of Fishawack Indicia or advisory role: EMD Serono, Sanofi, PharmaMar, Daiichi Sankyo, WIRB-Copernicus Group, ZIOPHARM Oncology, Polaris, Mirati Therapeutics, MJH Associates, Medscape, ICON Clinical Research, Acrivon Therapeutics, Arsenal Capital; leadership: Blueprint Medicines, Merrimack, Translate BIO; expert testimony: Epizyme; patents, royalties, other intellectual property (IP): Dana-Farber/Novartis; stock and other ownership interests: Bessor Pharma, under approval by the appropriate institutional review Cy, cyclophosphamide; DCR, disease control 2. Riedel RF, et al. Cancers 2018;10:E417. Ltd, UK, funded by GSK. We thank Dr Steven Attia (Mayo Clinic in Florida, Jacksonville, FL), Dr David Loeb Champions Oncology, Merrimack, Erasca Inc, Translate BIO; research funding (to institution):
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