دورية أكاديمية
Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.
العنوان: | Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results. |
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المؤلفون: | 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, Khushalani, Nikhil I |
المصدر: | Articles, Abstracts, and Reports |
بيانات النشر: | Providence Digital Commons |
سنة النشر: | 2023 |
المجموعة: | Providence St. Joseph Health Digital Commons |
مصطلحات موضوعية: | oregon, chiles, Humans, Nivolumab, Ipilimumab, Antineoplastic Combined Chemotherapy Protocols, Melanoma, Oncology |
الوصف: | 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. |
نوع الوثيقة: | text |
اللغة: | unknown |
العلاقة: | https://digitalcommons.providence.org/publications/7906Test; https://pubmed.ncbi.nlm.nih.gov/37651676Test |
الإتاحة: | https://digitalcommons.providence.org/publications/7906Test https://pubmed.ncbi.nlm.nih.gov/37651676Test |
رقم الانضمام: | edsbas.565F621B |
قاعدة البيانات: | BASE |
الوصف غير متاح. |