dc.contributor.author | Ascierto, PA | |
dc.contributor.author | Lipson, EJ | |
dc.contributor.author | Dummer, R | |
dc.contributor.author | Larkin, J | |
dc.contributor.author | Long, GV | |
dc.contributor.author | Sanborn, RE | |
dc.contributor.author | Chiarion-Sileni, V | |
dc.contributor.author | Dréno, B | |
dc.contributor.author | Dalle, S | |
dc.contributor.author | Schadendorf, D | |
dc.contributor.author | Callahan, MK | |
dc.contributor.author | Nyakas, M | |
dc.contributor.author | Atkinson, V | |
dc.contributor.author | Gomez-Roca, CA | |
dc.contributor.author | Yamazaki, N | |
dc.contributor.author | Tawbi, HA | |
dc.contributor.author | Sarkis, N | |
dc.contributor.author | Warad, D | |
dc.contributor.author | Dolfi, S | |
dc.contributor.author | Mitra, P | |
dc.contributor.author | Suryawanshi, S | |
dc.contributor.author | Grob, J-J | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-05-05T13:41:47Z | |
dc.date.available | 2023-05-05T13:41:47Z | |
dc.date.issued | 2023-02-13 | |
dc.identifier.citation | Journal of Clinical Oncology, 2023, pp. JCO2202072 - | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5779 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.22.02072 | |
dc.description.abstract | PURPOSE: Nivolumab and relatlimab activity in advanced melanoma with prior progression on anti-programmed death-1/programmed death ligand 1 (PD-(L)1)-containing regimens is under investigation. RELATIVITY-047 demonstrated significantly improved progression-free survival (PFS) for nivolumab and relatlimab over nivolumab in previously untreated advanced melanoma. METHODS: The phase I/IIa, open-label RELATIVITY-020 trial part D assessed efficacy and safety of nivolumab and relatlimab in advanced melanoma with progression during, or within 3 months of, 1 (D1) or ≥ 1 (D2) anti-PD-(L)1-containing regimens. Safety was a primary end point. Objective response rate (coprimary end point) and PFS by blinded independent central review (BICR) were assessed. RESULTS: Five hundred eighteen patients (D1 = 354; D2 = 164) received nivolumab and relatlimab. Among evaluable patients, the objective response rate by BICR was 12.0% (95% CI, 8.8 to 15.8) in D1 (n = 351) and 9.2% (95% CI, 5.2 to 14.7) in D2 (n = 163). Responses appeared to be enriched among patients with tumors expressing programmed death ligand 1 or lymphocyte activation gene 3; however, responses were observed regardless of programmed death ligand 1 and lymphocyte activation gene 3 expression (1%). The median duration of response was not reached (95% CI, 12.9 to not reached) in D1 and 12.8 months (95% CI, 6.9 to 12.9) in D2. The median PFS by BICR was 2.1 months (95% CI, 1.9 to 3.5) in D1 and 3.2 months (95% CI, 1.9 to 3.6) in D2; the 6-month PFS rate was 29.1% (95% CI, 24.2 to 34.1) and 27.7% (95% CI, 20.5 to 35.4), respectively. The grade 3-4 treatment-related adverse event incidence was 15.0% in D1 and 12.8% in D2. One case of grade 3 myocarditis and no treatment-related deaths occurred across part D. CONCLUSION: Nivolumab and relatlimab had a manageable safety profile and demonstrated durable clinical activity in a proportion of patients with heavily pretreated advanced melanoma with prior progression on anti-PD-(L)1-containing regimens.[Media: see text]. | |
dc.format | Print-Electronic | |
dc.format.extent | JCO2202072 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | American Society of Clinical Oncology (ASCO) | |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.title | Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-01-04 | |
dc.date.updated | 2023-05-05T13:40:09Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/JCO.22.02072 | |
rioxxterms.licenseref.startdate | 2023-02-13 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36780608 | |
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/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.22.02072 | |
dc.contributor.icrauthor | Larkin, James | |
icr.provenance | Deposited by Mr Arek Surman on 2023-05-05. Deposit type is initial. No. of files: 1. Files: jco.22.02072.pdf | |