Journal article
Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results
A Diab, H Gogas, S Sandhu, GV Long, PA Ascierto, J Larkin, M Sznol, F Franke, TE Ciuleanu, C Pereira, E Muñoz Couselo, F Bronzon Damian, M Schenker, A Perfetti, C Lebbe, G Quéreux, F Meier, BD Curti, C Rojas, Y Arriaga Show all
Journal of Clinical Oncology | LIPPINCOTT WILLIAMS & WILKINS | Published : 2023
DOI: 10.1200/JCO.23.00172
Open access
Abstract
PURPOSEDespite 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.METHODSPatients 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 independen..
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Funding Acknowledgements
The authors thank the patients and their families, as well as the participating trial teams, for making this trial possible; Maria Serrano of Bristol Myers Squibb for her contributions as the protocol manager of this trial; Antara Datta from the Translational Medicine team; Aparna Chhibber from the Informatics and Predictive Sciences team; Aparna Nanduri and Blisse Vakkalagadda from Clinical Pharmacology & Pharmacometrics; Dennis Stocker from Nonclinical Disposition & Bioanalysis; and all teams who participated in this study. They also acknowledge Bristol Myers Squibb (NJ), Nektar Therapeutics (CA), and Ono Pharmaceutical Company, Ltd (Osaka, Japan). Medical writing and editorial support were provided by S.L. Thier and M. Salernitano of Ashfield MedComms (NJ) and funded by Bristol Myers Squibb.