1075P - Open label non-randomized multi-cohort pilot study of genetically engineered NY-ESO-1 specific NY-ESO-1c259 SPEAR T-cellsTM in HLA-A*02+ patients w...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Immunotherapy
Therapy
Presenter Crystal Mackall
Citation Annals of Oncology (2016) 27 (6): 359-378. 10.1093/annonc/mdw378
Authors C. Mackall1, S. D'Angelo2, S. Grupp3, J. Glod4, M. Druta5, W. Chow6, K. Chagin7, M. Mehler8, G. Kari8, T. Trivedi8, T. Holdich9, L. Pandite8, R. Amado8
  • 1Stanford Cancer Institute, Stanford University Medical Center, 94305 - Stanford/US
  • 2Medicine, Memorial Sloan Kettering Cancer Center, New York/US
  • 3Pediatrics, Children's Hospital of Philadelphia, Philadelphia/US
  • 4Center For Cancer Research, National Cancer Institute, Washington/US
  • 5Oncology, Moffitt Cancer Center, Tampa/US
  • 6Medical Oncology, City of Hope, Duarte/US
  • 7Global Clinical Development, Adaptimmune, Philadelphia/US
  • 8Global Clinical Development, Adaptimmune LLC, Philadelphia/US
  • 9Global Clinical Development, Adaptimmune LTD, Oxford/GB

Abstract

Background

NY-ESO-1, a member of the cancer-testis family of tumor antigens, is expressed in ∼ 70% of Synovial Sarcoma (SS) cases. NY-ESO-1c259 SPEAR T-cellsTM recognizing the NY-ESO-1 derived SLLMWITQC peptide complexed with HLA-A*02 have been developed for study in SS.

Methods

The primary endpoint of overall response rate [ORR (CR + PR)] will be evaluated in high NY-ESO expressers [2 + , 3+ NY-ESO in ≥50% of tumor cells by IHC (Cohorts 1, 3, and 4)] and low expressers [1+ in >1%, 2 + , 3+ in

Results

Enrollment in cohort 1 is complete (12 pts), ongoing in cohorts 2 and 3 (2 in each). ORR in cohort 1 is 50% (1 CR; 5 PR). Two pts receiving non target doses (

Conclusions

The NY-ESO-1c259 SPEAR T-cellsTM have promising efficacy and acceptable safety profile in pts with SS who highly express NY-ESO. Efficacy and safety data will be further evaluated and presented from subjects enrolled in all cohorts.

Clinical trial identification

NCT01343043

Legal entity responsible for the study

Adaptimmune LLC

Funding

Adaptimmune LLC

Disclosure

K. Chagin, M. Mehler, G. Kari, T. Trivedi, T. Holdich, R. Amado: Author is an employee of Adaptimmune. L. Pandite: I am an employee of Adaptimmune. All other authors have declared no conflicts of interest.