Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
oregon; chiles; Humans; Nivolumab; Ipilimumab; Antineoplastic Combined Chemotherapy Protocols; Melanoma
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
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.
Diab, Adi; Gogas, Helen; Sandhu, Shahneen; Long, Georgina V; Ascierto, Paolo A; Larkin, James; Sznol, Mario; Franke, Fabio; Ciuleanu, Tudor E; Pereira, Caio; Muñoz Couselo, Eva; Bronzon Damian, Fernanda; Schenker, Michael; Perfetti, Aldo; Lebbe, Celeste; Quéreux, Gaëlle; Meier, Friedegund; Curti, Brendan; Rojas, Carlos; Arriaga, Yull; Yang, Haisu; Zhou, Ming; Ravimohan, Shruthi; Statkevich, Paul; Tagliaferri, Mary A; and Khushalani, Nikhil I, "Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results." (2023). Articles, Abstracts, and Reports. 7906.