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IGNYTE-ESO

IGNYTE-ESO was the pivotal study for the second sarcoma TCR-T, with responses in 42% of patients with two rare sarcomas.

ORR 42% by independent review (41% synovial sarcoma, 43% MRCLS); median DOR 12.2 months overall, 18.3 in synovial sarcoma; cytopenias and CRS as expected. Basis for a BLA due by end-2026 (US WorldMeds).

Setting
Advanced synovial sarcoma or myxoid/round cell liposarcoma, NY-ESO-1+, HLA-A*02+: lete-cel (single arm)
Phase
Phase 2
Sponsor
Adaptimmune / GSK
Registry
Headline result
ORR 42%.
Reported
2024
Enrolled
64

Outcomes

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In plain words
What these results mean for people, not percentages
64 people took part
Objective response rateprimaryresponse endpoint
  • 42 out of 100 people had their tumour shrink with Lete-cel.
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
  • These results apply to the people the trial enrolled: Advanced synovial sarcoma or myxoid/round cell liposarcoma, NY-ESO-1+, HLA-A*02+: lete-cel (single arm). People in a different situation may not see the same effect.
  • Only 64 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

64 participants enrolled.

Objective response rateprimary
Lete-cel42 of 100
n = 64
Source
EndpointArmnValueHR (95% CI)pSource
Objective response rateprimaryLete-cel6442%link

Connected

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