C-144-01
The single-arm study that got the first cell therapy for a solid tumour approved: one in three patients responded after everything else had failed.
ORR 31.4% in the pivotal cohort; median duration of response 36.5 months in the 5-year analysis, with ~31% of responders still responding at five years. Accelerated FDA approval February 2024. TILVANCE-301 (first-line, with pembrolizumab) is the confirmatory trial.
Setting
Advanced melanoma progressing after anti-PD-1 (and BRAF/MEK if applicable): single infusion of lifileucel TIL
Phase
Phase 2
Sponsor
Iovance
Registry
Headline result
ORR 31.4%; median DOR 36.5 months (5-year analysis).
Reported
2021
Enrolled
153
Replication
Consistent with decades of NCI Surgery Branch TIL series; randomised confirmation pending (TILVANCE-301).
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 31.4 out of 100 people had their tumour shrink with Lifileucel.
- 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 melanoma progressing after anti-PD-1 (and BRAF/MEK if applicable): single infusion of lifileucel TIL. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.
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.