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dc.contributor.authorSarnaik, AA
dc.contributor.authorHamid, O
dc.contributor.authorKhushalani, NI
dc.contributor.authorLewis, KD
dc.contributor.authorMedina, T
dc.contributor.authorKluger, HM
dc.contributor.authorThomas, SS
dc.contributor.authorDomingo-Musibay, E
dc.contributor.authorPavlick, AC
dc.contributor.authorWhitman, ED
dc.contributor.authorMartin-Algarra, S
dc.contributor.authorCorrie, P
dc.contributor.authorCurti, BD
dc.contributor.authorOláh, J
dc.contributor.authorLutzky, J
dc.contributor.authorWeber, JS
dc.contributor.authorLarkin, JMG
dc.contributor.authorShi, W
dc.contributor.authorTakamura, T
dc.contributor.authorJagasia, M
dc.contributor.authorQin, H
dc.contributor.authorWu, X
dc.contributor.authorChartier, C
dc.contributor.authorGraf Finckenstein, F
dc.contributor.authorFardis, M
dc.contributor.authorKirkwood, JM
dc.contributor.authorChesney, JA
dc.date.accessioned2021-05-20T13:05:39Z
dc.date.available2021-05-20T13:05:39Z
dc.date.issued2021-05-12
dc.identifier.citationJournal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021, pp. JCO2100612 - ?
dc.identifier.issn0732-183X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4564
dc.identifier.eissn1527-7755
dc.identifier.doi10.1200/jco.21.00612
dc.description.abstractPurpose Effective treatment options are limited for patients with advanced (metastatic or unresectable) melanoma who progress after immune checkpoint inhibitors and targeted therapies. Adoptive cell therapy using tumor-infiltrating lymphocytes has demonstrated efficacy in advanced melanoma. Lifileucel is an autologous, centrally manufactured tumor-infiltrating lymphocyte product.Methods We conducted a phase II open-label, single-arm, multicenter study in patients with advanced melanoma who had been previously treated with checkpoint inhibitor(s) and BRAF ± MEK targeted agents. Lifileucel was produced from harvested tumor specimens in central Good Manufacturing Practice facilities using a streamlined 22-day process. Patients received a nonmyeloablative lymphodepletion regimen, a single infusion of lifileucel, and up to six doses of high-dose interleukin-2. The primary end point was investigator-assessed objective response rate (ORR) per RECIST, version 1.1.Results Sixty-six patients received a mean of 3.3 prior therapies (anti-programmed death 1 [PD-1] or programmed death ligand 1 [PD-L1]: 100%; anticytotoxic T-lymphocyte-associated protein-4: 80%; BRAF ± MEK inhibitor: 23%). The ORR was 36% (95% CI, 25 to 49), with two complete responses and 22 partial responses. Disease control rate was 80% (95% CI, 69 to 89). Median duration of response was not reached after 18.7-month median study follow-up (range, 0.2-34.1 months). In the primary refractory to anti-PD-1 or PD-L1 therapy subset, the ORR and disease control rate were 41% (95% CI, 26 to 57) and 81% (95% CI, 66 to 91), respectively. Safety profile was consistent with known adverse events associated with nonmyeloablative lymphodepletion and interleukin-2.Conclusion Lifileucel demonstrated durable responses and addresses a major unmet need in patients with metastatic melanoma with limited treatment options after approved therapy, including the primary refractory to anti-PD-1 or PD-L1 therapy subset.
dc.formatPrint-Electronic
dc.format.extentJCO2100612 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0
dc.titleLifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.
dc.typeJournal Article
dcterms.dateAccepted2021-05-12
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1200/jco.21.00612
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc-nd/4.0
rioxxterms.licenseref.startdate2021-05-12
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of clinical oncology : official journal of the American Society of Clinical Oncology
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.embargo.termsNot known
icr.researchteamMelanoma and Kidney Cancer
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen


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