dc.contributor.author | Diab, A | |
dc.contributor.author | Gogas, H | |
dc.contributor.author | Sandhu, S | |
dc.contributor.author | Long, GV | |
dc.contributor.author | Ascierto, PA | |
dc.contributor.author | Larkin, J | |
dc.contributor.author | Sznol, M | |
dc.contributor.author | Franke, F | |
dc.contributor.author | Ciuleanu, TE | |
dc.contributor.author | Pereira, C | |
dc.contributor.author | Muñoz Couselo, E | |
dc.contributor.author | Bronzon Damian, F | |
dc.contributor.author | Schenker, M | |
dc.contributor.author | Perfetti, A | |
dc.contributor.author | Lebbe, C | |
dc.contributor.author | Quéreux, G | |
dc.contributor.author | Meier, F | |
dc.contributor.author | Curti, BD | |
dc.contributor.author | Rojas, C | |
dc.contributor.author | Arriaga, Y | |
dc.contributor.author | Yang, H | |
dc.contributor.author | Zhou, M | |
dc.contributor.author | Ravimohan, S | |
dc.contributor.author | Statkevich, P | |
dc.contributor.author | Tagliaferri, MA | |
dc.contributor.author | Khushalani, NI | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2023-11-23T11:12:31Z | |
dc.date.available | 2023-11-23T11:12:31Z | |
dc.date.issued | 2023-10-20 | |
dc.identifier.citation | Journal of Clinical Oncology, 2023, 41 (30), pp. 4756 - 4767 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/6070 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.23.00172 | |
dc.identifier.doi | 10.1200/JCO.23.00172 | |
dc.description.abstract | PURPOSE: Despite marked advances in the treatment of unresectable or metastatic melanoma, the need for novel therapies remains. Bempegaldesleukin (BEMPEG), a pegylated interleukin-2 (IL-2) cytokine prodrug, demonstrated efficacy in the phase II PIVOT-02 trial. PIVOT IO 001 (ClinicalTrials.gov identifier: NCT03635983) is a phase III, randomized, open-label study that builds on the PIVOT-02 results in first-line melanoma. METHODS: Patients with previously untreated, unresectable, or metastatic melanoma were randomly assigned 1:1 to receive BEMPEG plus nivolumab (NIVO) or NIVO monotherapy. Primary end points were objective response rate (ORR) and progression-free survival (PFS) by blinded independent central review and overall survival (OS). Secondary and exploratory end points included additional efficacy measures, safety, and pharmacokinetics (PKs) and pharmacodynamics analyses. RESULTS: In 783 patients (n = 391, BEMPEG plus NIVO; n = 392, NIVO monotherapy), the median follow-up was 11.6 months in the intent-to-treat population. The ORR with BEMPEG plus NIVO was 27.7% versus 36.0% with NIVO (two-sided P = .0311). The median PFS with BEMPEG plus NIVO was 4.17 months (95% CI, 3.52 to 5.55) versus 4.99 months (95% CI, 4.14 to 7.82) with NIVO (hazard ratio [HR], 1.09; 97% CI, 0.88 to 1.35; P = .3988). The median OS was 29.67 months (95% CI, 22.14 to not reached [NR]) with BEMPEG plus NIVO versus 28.88 months (95% CI, 21.32 to NR) with NIVO (HR, 0.94; 99.929% CI, 0.59 to 1.48; P = .6361). Grade 3-4 treatment-related adverse events (AEs) and serious AE rates were higher with the combination (21.7% and 10.1%, respectively) versus NIVO (11.5% and 5.5%, respectively). BEMPEG PK exposure and absolute lymphocyte count changes after BEMPEG plus NIVO were comparable between PIVOT IO 001 and PIVOT-02. CONCLUSION: The PIVOT IO 001 study did not meet its primary end points of ORR, PFS, and OS. Increased toxicity was observed with BEMPEG plus NIVO versus NIVO. | |
dc.format | Print-Electronic | |
dc.format.extent | 4756 - 4767 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Humans | |
dc.subject | Nivolumab | |
dc.subject | Ipilimumab | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Melanoma | |
dc.title | Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-06-29 | |
dc.date.updated | 2023-11-23T10:49:03Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1200/JCO.23.00172 | |
rioxxterms.licenseref.startdate | 2023-10-20 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37651676 | |
pubs.issue | 30 | |
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 | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.23.00172 | |
pubs.volume | 41 | |
dc.contributor.icrauthor | Larkin, James | |
icr.provenance | Deposited by Mr Arek Surman on 2023-11-23. Deposit type is initial. No. of files: 1. Files: diab-et-al-2023-bempegaldesleukin-plus-nivolumab-in-untreated-advanced-melanoma-the-open-label-phase-iii-pivot-io-001.pdf | |