LN-144
Lifileucel (LN-144), autologous tumour-infiltrating lymphocytes, in metastatic melanoma after checkpoint inhibitor and targeted therapy: cohort 2 of a multicohort phase 2 study (ClinicalTrials.gov NCT02360579, study ID C-144-01)
Phase 2N = 66NCT02360579
- Population
- Patients with advanced (metastatic or unresectable) melanoma previously treated with checkpoint inhibitor(s) and, where applicable, BRAF with or without MEK targeted agents; the 66 patients in this report had a mean of 3.3 prior therapies (anti-PD-1 or PD-L1: 100%; anti-CTLA-4: 80%; BRAF with or without MEK inhibitor: 23%).
- Design
- Open-label, single-arm, multicentre phase 2 study (cohort 2 of a multicohort parent study; 26 sites). Lifileucel was manufactured centrally by a 22-day process; patients received nonmyeloablative lymphodepletion, a single lifileucel infusion and up to six doses of high-dose interleukin-2.
- Primary endpoint
- ORR
- Arms
- Lifileucel (experimental, n = 66): Nonmyeloablative lymphodepletion, one lifileucel infusion, then up to six doses of high-dose interleukin-2
- People
- Sarnaik AA, senior author Chesney JA
Show the numbers
| Endpoint | Analysis | Lifileucel | Control | Effect |
|---|---|---|---|---|
| ORRFull analysis set: cohort 2 patients who received lifileucel meeting manufacturer's specifications (n=66); single-arm, not an ITT populationInvestigator-assessed objective response rate per RECIST version 1.1 | primarymedian follow-up 18.7 monthsSarnaik 2021 | 36% (25–49%) | — | Two complete responses and 22 partial responses. Disease control rate 80% (95% CI 69 to 89). Median duration of response not reached after 18.7 months' median study follow-up (range 0.2 to 34.1 months). |
| ORRSubset with disease primary refractory to anti-PD-1 or PD-L1 therapy (42 patients, from the full text)Investigator-assessed objective response rate per RECIST version 1.1 | exploratorySarnaik 2021 | 41% (26–57%) | — | Disease control rate in this subset 81% (95% CI 66 to 91). |
| Endpoint | Analysis | Lifileucel | Control | Effect |
|---|---|---|---|---|
| ORRFull analysis set: cohort 2 patients who received lifileucel meeting manufacturer's specifications (n=66); single-arm, not an ITT populationInvestigator-assessed objective response rate per RECIST version 1.1 | primarymedian follow-up 18.7 monthsSarnaik 2021 | 36% (25–49%) | — | Two complete responses and 22 partial responses. Disease control rate 80% (95% CI 69 to 89). Median duration of response not reached after 18.7 months' median study follow-up (range 0.2 to 34.1 months). |
| ORRSubset with disease primary refractory to anti-PD-1 or PD-L1 therapy (42 patients, from the full text)Investigator-assessed objective response rate per RECIST version 1.1 | exploratorySarnaik 2021 | 41% (26–57%) | — | Disease control rate in this subset 81% (95% CI 66 to 91). |