dc.contributor.author | Sarnaik, AA | |
dc.contributor.author | Hamid, O | |
dc.contributor.author | Khushalani, NI | |
dc.contributor.author | Lewis, KD | |
dc.contributor.author | Medina, T | |
dc.contributor.author | Kluger, HM | |
dc.contributor.author | Thomas, SS | |
dc.contributor.author | Domingo-Musibay, E | |
dc.contributor.author | Pavlick, AC | |
dc.contributor.author | Whitman, ED | |
dc.contributor.author | Martin-Algarra, S | |
dc.contributor.author | Corrie, P | |
dc.contributor.author | Curti, BD | |
dc.contributor.author | Oláh, J | |
dc.contributor.author | Lutzky, J | |
dc.contributor.author | Weber, JS | |
dc.contributor.author | Larkin, JMG | |
dc.contributor.author | Shi, W | |
dc.contributor.author | Takamura, T | |
dc.contributor.author | Jagasia, M | |
dc.contributor.author | Qin, H | |
dc.contributor.author | Wu, X | |
dc.contributor.author | Chartier, C | |
dc.contributor.author | Graf Finckenstein, F | |
dc.contributor.author | Fardis, M | |
dc.contributor.author | Kirkwood, JM | |
dc.contributor.author | Chesney, JA | |
dc.date.accessioned | 2021-05-20T13:05:39Z | |
dc.date.available | 2021-05-20T13:05:39Z | |
dc.date.issued | 2021-05-12 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021, pp. JCO2100612 - ? | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4564 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.21.00612 | |
dc.description.abstract | Purpose 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.format | Print-Electronic | |
dc.format.extent | JCO2100612 - ? | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
dc.title | Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-05-12 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/jco.21.00612 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
rioxxterms.licenseref.startdate | 2021-05-12 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.notes | Not 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-status | Published | |
pubs.embargo.terms | Not known | |
icr.researchteam | Melanoma and Kidney Cancer | |
icr.researchteam | Melanoma and Kidney Cancer | en_US |
dc.contributor.icrauthor | Larkin, James | en |