Found 1 Presentation For Request "SURPASS"
540P - Safety and efficacy from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating a CD8α co-receptor and an affinity optimized TCR targeting MAGE-A4
- David S. Hong (Houston, United States of America)
Abstract
Background
The ongoing phase 1 SURPASS trial (NCT04044859) evaluates safety and efficacy of next-generation ADP-A2M4CD8 SPEAR T-cells co-expressing the CD8α co-receptor with the engineered T-cell receptor (TCR) targeting MAGE-A4.
Methods
First-in-human trial in HLA-A*02 positive patients (pts) with advanced cancers expressing MAGE-A4 antigen. T-cells are obtained by apheresis, transduced with a lentiviral vector containing the engineered TCR and CD8α co-receptor, and expanded in vitro. Prior to infusion, pts receive lymphodepletion with fludarabine 30 mg/m2/day for 4 days and cyclophosphamide 600 mg/m2/day for 3 days. The study consists of a modified 3 + 3 dose escalation design with an expansion cohort. Clinical outcomes (safety and efficacy), product attributes (dose, cell phenotype), and biomarkers (tumor antigen expression, T-cell persistence after transfer, serum cytokines) are evaluated.
Results
As of 05 Apr 2021, 18 pts (10 male, 8 female) were treated with ADP-A2M4CD8 (range 1.0 to 6 billion transduced cells). Median age was 63.5 yrs, median H-score was 255 (range 130 to 300), and primary tumor types included ovarian (n=5), esophagogastric junction (n=4), esophageal (n=2), head and neck (n=2), and 1 pt each with myxoid/round cell liposarcoma, melanoma, non small cell lung cancer, synovial sarcoma, and urothelial cancers. Overall, patients tolerated treatment. Most adverse events were consistent with those experienced by cancer patients undergoing lymphodepletion chemotherapy and cellular therapy. Of the 18 pts treated as of the data cut-off, 2 pts were awaiting first scans and one patient had expired. Of the 15 evaluable pts, 13 had evidence of disease control and there were RECIST responses in several solid tumor types. This trial is ongoing with additional pts awaiting treatment and further tumor assessments.
Conclusions
ADP-A2M4CD8 SPEAR T-cells have shown an acceptable safety profile. Emerging efficacy data remain encouraging with the majority of pts experiencing disease control and RECIST responses in several solid tumor types. A full update will be presented at the conference.
Clinical trial identification
NCT04044859.
Editorial acknowledgement
Writing and editorial support was provided by Gabrielle Knafler, of Excel Scientific Solutions (Fairfield, CT, USA).
Legal entity responsible for the study
Adaptimmune.
Funding
Adaptimmune.
Disclosure
D.S. Hong: Financial Interests, Personal, Research Grant: AbbVie; Financial Interests, Personal, Research Grant: Adaptimmune; Financial Interests, Personal, Research Grant: Adlai Nortye; Financial Interests, Personal, Research Grant: Amgen; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Bayer; Financial Interests, Personal, Research Grant: Bristol Myers Squibb; Financial Interests, Personal, Research Grant: Daiichi-Sankyo; Financial Interests, Personal, Research Grant: Eisai; Financial Interests, Personal, Research Grant: Eli Lilly; Financial Interests, Personal, Research Grant: EMD Serono; Financial Interests, Personal, Research Grant: Erasca; Financial Interests, Personal, Research Grant: Fate Therapeutics; Financial Interests, Personal, Research Grant: Genentech; Financial Interests, Personal, Research Grant: Genmab; Financial Interests, Personal, Research Grant: GlaxoSmithKline; Financial Interests, Personal, Research Grant: Ignyta; Financial Interests, Personal, Research Grant: Infinity; Financial Interests, Personal, Research Grant: Kite; Financial Interests, Personal, Research Grant: Kyowa; Financial Interests, Personal, Research Grant: LOXO; Financial Interests, Personal, Research Grant: Merck; Financial Interests, Personal, Research Grant: MedImmune; Financial Interests, Personal, Research Grant: Millenium; Financial Interests, Personal, Research Grant: Mirati; Financial Interests, Personal, Research Grant: miRNA; Financial Interests, Personal, Research Grant: Molecular Templates; Financial Interests, Personal, Research Grant: Mologen; Financial Interests, Personal, Research Grant: Navier; Financial Interests, Personal, Research Grant: NCI-CTEP; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Numab; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: Seattle Genetics; Financial Interests, Personal, Research Grant: Takeda; 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Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Janssen; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: LOXO; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: miRNA; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Philips; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: SITC; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Takeda; Financial Interests, Personal, Ownership Interest: Molecular Match; Financial Interests, Personal, Ownership Interest: OncoResponse; Financial Interests, Personal, Ownership Interest: Presagia Inc; Financial Interests, Personal, Advisory Role: Alpha Insights; Financial Interests, Personal, Advisory Role: Acuta; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Axiom; Financial Interests, Personal, Advisory Role: Adaptimmune; Financial Interests, Personal, Advisory Role: Baxter; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Boxer Capital; Financial Interests, Personal, Advisory Role: COG; Financial Interests, Personal, Advisory Role: Ecor1; Financial Interests, Personal, Advisory Role: Genentech; Financial Interests, Personal, Advisory Role: GLG; Financial Interests, Personal, Advisory Role: Group H; Financial Interests, Personal, Advisory Role: Guidepoint; Financial Interests, Personal, Advisory Role: HCW Precision; Financial Interests, Personal, Advisory Role: Infinity; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Advisory Role: Merrimack; Financial Interests, Personal, Advisory Role: Medscape; Financial Interests, Personal, Advisory Role: Numab; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Prime Oncology; Financial Interests, Personal, Advisory Role: Seattle Genetics; Financial Interests, Personal, Advisory Role: ST Cube; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Advisory Role: Tavistock; Financial Interests, Personal, Advisory Role: Trieza Therapeutics; Financial Interests, Personal, Advisory Role: WebMD. J.M. Clarke: Financial Interests, Speaker’s Bureau: Merck; Financial Interests, Speaker’s Bureau: AstraZeneca; Financial Interests, Training: BMS; Financial Interests, Other, Consultant: AstraZeneca; Financial Interests, Other, Consultant: Merck; Financial Interests, Other, Consultant: Pfizer; Financial Interests, Other, Consultant: NGM Biopharmaceuticals; Financial Interests, Other, Consultant: Spectrum; Financial Interests, Other, Consultant: Genentech; Financial Interests, Research Grant: Bristol-Myers Squibb; Financial Interests, Research Grant: Genentech; Financial Interests, Research Grant: Spectrum; Financial Interests, Research Grant: Adaptimmune; Financial Interests, Research Grant: Medpacto; Financial Interests, Research Grant: Bayer; Financial Interests, Research Grant: AbbVie; Financial Interests, Research Grant: Moderna; Financial Interests, Research Grant: GlaxoSmithKline; Financial Interests, Research Grant: Array; Financial Interests, Research Grant: AstraZeneca; Financial Interests, Research Grant: Grid Therapeutics; Financial Interests, Research Grant: CBMG; Non-Financial Interests, Member of the Board of Directors: Lung Cancer Initiative of North Carolina. J. Charlson: Financial Interests, Other, Consultant: Deciphera; Financial Interests, Other, Consultant: Adaptimmune; Financial Interests, Advisory Board: Adaptimmune. E. Calvo: Financial Interests, Personal, Advisory Board: Adcendo; Financial Interests, Personal, Advisory Board: Alkermes; Financial Interests, Personal, Advisory Board: Amunix; Financial Interests, Personal, Advisory Board: Anaveon; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: MonTa; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Nanobiotix; Financial Interests, Personal, Advisory Board: Nouscom; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: OncoDNA; Financial Interests, Personal, Invited Speaker: PharmaMar; Financial Interests, Personal, Invited Speaker: Roche/Genentech; Financial Interests, Personal, Advisory Board: Servier; Financial Interests, Personal, Advisory Board: TargImmune; Financial Interests, Personal, Advisory Board: T-knife; Financial Interests, Personal, Advisory Board: Chugai; Financial Interests, Personal, Other, Director, Clinical Research: START Madrid Group; Financial Interests, Personal, Full or part-time Employment: HM Hospitales Group; Financial Interests, Personal, Full or part-time Employment: START Madrid - CIOCC (Centro Integral Oncológico Clara Campal); Financial Interests, Personal, Ownership Interest: START; Financial Interests, Personal, Ownership Interest: Oncoart Associated; Financial Interests, Personal, Ownership Interest: International Cancer Consultants; Financial Interests, Institutional, Funding: Achilles; Financial Interests, Personal, Other, Steering Committee Member: BeiGene; Financial Interests, Personal, Other, Steering Committee Member: MedSIR; Non-Financial Interests, Personal, Officer, Steering Committee Member: EORTC IDMC; Non-Financial Interests, Personal, Member of the Board of Directors: INTHEOS (Investigational Therapeutics in Oncological Sciences) Foundation; Non-Financial Interests, Personal, Advisory Role: PsiOxus; Non-Financial Interests, Personal, Advisory Role: Amcure; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: SEOM; Non-Financial Interests, Personal, Member: EORTC. V. Boni: Financial Interests, Personal, Speaker’s Bureau: Lilly; Financial Interests, Personal, Other, Consultant: Puma; Financial Interests, Personal, Other, Consultant: Cytomx; Financial Interests, Personal, Other, Consultant: Loxo Oncology; Financial Interests, Personal, Other, Consultant: Amunix; Financial Interests, Personal, Other, Consultant: Ideaya; Financial Interests, Institutional, Research Grant: Abbvie; Financial Interests, Institutional, Research Grant: ACEO; Financial Interests, Institutional, Research Grant: Adaptaimmune; Financial Interests, Institutional, Research Grant: Amcure; Financial Interests, Institutional, Research Grant: AMGEN; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Cytomx; Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Institutional, Research Grant: Genentech/Roche; Financial Interests, Institutional, Research Grant: H3; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Kura; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Loxo; Financial Interests, Institutional, Research Grant: Nektar; Financial Interests, Institutional, Research Grant: Macrogenics; Financial Interests, Institutional, Research Grant: Menarini; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Merus; Financial Interests, Institutional, Research Grant: Nanobiotix; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: PharmaMar; Financial Interests, Institutional, Research Grant: Principia; Financial Interests, Institutional, Research Grant: PUMA; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Taiho; Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Research Grant: BeiGene; Financial Interests, Institutional, Research Grant: Transgene; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Innovio; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: PsiOxus; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Mersana; Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Institutional, Research Grant: Daiichi; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Research Grant: ORCA; Financial Interests, Institutional, Research Grant: Boston Therapeutics; Financial Interests, Institutional, Research Grant: Dynavax; Financial Interests, Institutional, Research Grant: DebioPharm; Financial Interests, Institutional, Research Grant: Boehringen Ingelheim; Financial Interests, Institutional, Research Grant: Regeneron; Financial Interests, Institutional, Research Grant: Millenium; Financial Interests, Institutional, Research Grant: Synthon; Financial Interests, Institutional, Research Grant: Spectrum; Financial Interests, Institutional, Research Grant: Rigontec; Financial Interests, Institutional, Research Grant: Zenith; Financial Interests, Personal, Member of the Board of Directors: Puma; Financial Interests, Personal, Member of the Board of Directors: Cytomx; Financial Interests, Personal, Member of the Board of Directors: Ideaya. J. Zugazagoitia: Financial Interests, Speaker’s Bureau: BMS; Financial Interests, Speaker’s Bureau: Roche; Financial Interests, Speaker’s Bureau: AstraZeneca; Financial Interests, Speaker’s Bureau: Pfizer; Financial Interests, Speaker’s Bureau: NanoString; Financial Interests, Research Grant: AstraZeneca. G.R. Blumenschein Jr.: Financial Interests, Personal, Research Grant: Amgen, Bayer, Adaptimmune, Elelixis, Daiichi Sankyo, GlaxoSmithKline, Immatics, Immunocore, Incyte, Kite Pharma, Macrogenics, Torque, AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, MedImmune, Merck, Novartis, Roche, Xcovery, Tmunity Therapeutics; Financial Interests, Personal, Other, Consulting Fees: Abbvie, Adicet, Amgen, Ariad, Bayer, Clovis Oncology, AstraZeneca, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Instil Bio, Genentech, Gilead, Lilly, Janssen, MedImmune, Merck, Novartis, Roche, Tyme Oncology, Xcovery, Virogin Biotech; Financial Interests, Personal, Other, Participation on a Data Safety Monitoring Board or Advisory Board: Virogin Biotech, Maverick therapeutics; Financial Interests, Personal, Stocks/Shares: Virogin Biotech; Non-Financial Interests, Personal, Other, Immediate family member employment: Johnson & Johnson/Janssen; Financial Interests, Personal, Research Grant: Regeneron, Beigene, Repertoire Immune Medicines, Verastem; Financial Interests, Personal, Other, Consulting Fees: Maverick Therapeutics. Q. Lin: Financial Interests, Personal, Full or part-time Employment: Adaptimmune. H. Danesi: Financial Interests, Personal, Full or part-time Employment: Adaptimmune. E. Norry: Financial Interests, Full or part-time Employment: Adaptimmune. All other authors have declared no conflicts of interest.