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.
- 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.
Pages like this
not linked directly; found by shared links- IdeaUse patient organoids to check a cell therapy will work before infusing it
Shares Iovance Biotherapeutics, Lifileucel, TIL therapy.
- PairingPD-1 failure → TIL therapy
Shares Lifileucel, TIL therapy, Melanoma.
- PersonSteven A. Rosenberg
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, Lifileucel, TIL therapy, Melanoma.
- IdeaSelect patients for cell therapy by whether their tumour holds reactive T cells
Shares Iovance Biotherapeutics, Lifileucel, TIL therapy, Melanoma.
- Key paperRohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, Lifileucel, TIL therapy, Melanoma.
- ProductAldesleukin (high-dose IL-2)
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, TIL therapy, Melanoma.
- PersonShari Pilon-Thomas
Shares TIL therapy, Melanoma.
- PersonPamela S. Ohashi
Shares TIL therapy, Melanoma.