Abstract 4935
Background
ImmTAC® bispecific molecules are unique TCR–anti-CD3 agents that redirect T cells against intracellular antigens, in contrast to antibody-based therapies, which are limited to extracellular antigens. The most advanced ImmTAC, tebentafusp (IMCgp100), against melanocyte-associated lineage antigen gp100, has shown monotherapy responses in advanced melanoma, a solid tumor. In contrast, bispecific antibodies have shown activity in hematologic cancers but appear less active in solid tumors. ImmTAC molecules recognize a specific peptide presented on a defined Class I HLA molecule via an affinity enhanced, engineered, soluble TCR. Through the addition of an anti-CD3 scFv domain fused to the TCR targeting domain, an ImmTAC can redirect T cell activity against cancer cells, regardless of the specificity of the T cell. IMCnyeso is an ImmTAC against NY-ESO-1/LAGE-1A, which are cancer testis antigens expressed in a variety of solid malignancies, but with very low or absent normal tissue expression.
Trial design
IMCnyeso-101 is a multi-center, open-label, first-in-human study of IMCnyeso in HLA-A*02:01-positive patients with NY-ESO-1- and/or LAGE-1A-positive advanced NSCLC, synovial sarcoma, melanoma, or urothelial carcinoma. The study includes dose escalation (Bayesian logistic regression models) and expansion for IMCnyeso monotherapy (QW), followed by expansion into indication specific arms to test for signs of efficacy in defined patient cohorts. Primary endpoints are establishing MTD/RP2D and safety and tolerability. Secondary endpoints include: characterization of PK and ADA, efficacy by RECIST v1.1 (PFS, ORR and DOR) and OS. The dose escalation portion of the study is in progress. The trial continues to enroll; NCT number NCT03515551.
Clinical trial identification
NCT03515551.
Editorial acknowledgement
Legal entity responsible for the study
Immunocore.
Funding
Immunocore.
Disclosure
J. Lopez: Research grant / Funding (institution), During the conduct of the study: Immunocore, Roche, Genentech; Advisory / Consultancy, Outside the submitted work: Novartis (personal fees); Research grant / Funding (institution), Outside the submitted work: MSD; Research grant / Funding (institution), Outside the submitted work (grant and non-financial support): Basilea; Advisory / Consultancy, Research grant / Funding (institution), Outside the submitted work: Genmab. T. Sato: Advisory / Consultancy: Immunocore; Advisory / Consultancy: IDEAYA Biosciences; Advisory / Consultancy: Neon Therapeutics, Inc. F. Thistlethwaite: Honoraria (self), Achilles Therapeutics. B. Van Tine: Honoraria (institution), Advisory / Consultancy: Immunocore ; Advisory / Consultancy: Epizyme; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy: CytRX; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen; Speaker Bureau / Expert testimony: Caris; Advisory / Consultancy: Immune Design; Advisory / Consultancy: Daiichi Sankyo; Speaker Bureau / Expert testimony: Adaptimmune; Advisory / Consultancy: Plexxicon; Advisory / Consultancy: Bayer; Advisory / Consultancy, Research grant / Funding (self): Pfizer; Research grant / Funding (self): Merck; Research grant / Funding (self): Tracon. J.A. Rodon: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy: Eli Lilly; Honoraria (self), Advisory / Consultancy: Orion Pharmaceuticals; Advisory / Consultancy: Servier Pharma; Honoraria (self), Advisory / Consultancy: Peptomyc; Honoraria (self): Merck Sharp; Advisory / Consultancy: Merck Sharp & Dome; Advisory / Consultancy: Kelun Pharma/Klus Pharma; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Advisory / Consultancy: Roche Pharma; Advisory / Consultancy: Elipses Pharma; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Spectrum Pharmaceuticals; Research grant / Funding (institution): Tocagen; Research grant / Funding (institution): Symphogen; Research grant / Funding (institution): BioAtla; Research grant / Funding (institution): GenMab; Research grant / Funding (institution): CytomX; Research grant / Funding (institution): Kelun-Biotech; Research grant / Funding (institution): Takeda-Millenium; Research grant / Funding (institution): Glaxosmithkline; Research grant / Funding (institution): Ipsen. J. Dukes: Shareholder / Stockholder / Stock options, Full / Part-time employment: Immunocore Ltd. R. Easton: Shareholder / Stockholder / Stock options, Full / Part-time employment: Immunocore. S. Marshall: Shareholder / Stockholder / Stock options, Full / Part-time employment: Immunocore. All other authors have declared no conflicts of interest.
Resources from the same session
5579 - Quality of informed consent in clinical trials patients
Presenter: Gianluca Catania
Session: Poster Display session 3
Resources:
Abstract
5147 - Patient's rights: Where do we stand?
Presenter: Maja Kozuh
Session: Poster Display session 3
Resources:
Abstract
1279 - The oncology nurse coordinator’s role in a digestive oncology department: Impact on patient and hospital
Presenter: Fouad Awada
Session: Poster Display session 3
Resources:
Abstract
1670 - Nursing model for a breast cancer unit at the Catalan Institute of Oncology
Presenter: Ana Rodriguez-ortega
Session: Poster Display session 3
Resources:
Abstract
3936 - Role of cancer nurse in the prevention and control of acute deterioration for oncohematologic patient
Presenter: Raquel Azor Portolés
Session: Poster Display session 3
Resources:
Abstract
2789 - Standardized nursing care in the department of radiotherapy of a network of cancer centres
Presenter: José Delgado
Session: Poster Display session 3
Resources:
Abstract
4482 - Exploring anxiety, depression and quality of life of ambulatory cancer patients during chemotherapy.
Presenter: Theodoula Adamakidou
Session: Poster Display session 3
Resources:
Abstract
3075 - Implementing a Cancer Survivorship Program for Individuals with Recurrent Breast Cancer
Presenter: Darcy Burbage
Session: Poster Display session 3
Resources:
Abstract
3869 - The perceptions of parents/guardians regarding their child/adolescent’s experience of reflexology or non-specific foot massage The perceptions of parents/guardians regarding their child/adolescents experience of reflexology or non-specific foot massage
Presenter: Patricia Fox
Session: Poster Display session 3
Resources:
Abstract
4064 - Quality of life in survivors of adult haematological malignancies
Presenter: Anita Immanuel
Session: Poster Display session 3
Resources:
Abstract