Journal article

Bempegaldesleukin plus nivolumab in untreated, unresectable or metastatic melanoma: Phase III PIVOT IO 001 study design

Nikhil Khushalani, Adi Diab, Paolo A Ascierto, James Larkin, Shahneen Sandhu, Mario Sznol, Henry B Koon, Anthony Jarkowski, Ming Zhou, Paul Statkevich, William J Geese, Georgina Long

Future Oncology | FUTURE MEDICINE LTD | Published : 2020

Abstract

Nivolumab, a PD-1 inhibitor, has demonstrated prolonged survival benefit in patients with advanced melanoma. Bempegaldesleukin (BEMPEG; NKTR-214), a first-in-class CD122-preferential IL-2 pathway agonist, provides sustained signaling through the IL-2βγ receptor, which activates effector T and natural killer cells. In the Phase I/II PIVOT-02 trial, the combination of bempegaldesleukin plus nivolumab was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. Here, we describe the design of and rationale for the Phase III, global, randomized, open-label PIVOT IO 001 trial comparing bempegaldesleukin plus nivolumab with nivolumab alone in patients with pr..

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Grants

Funding Acknowledgements

This study is supported by Bristol-Myers Squibb Company. NI Khushalani owns stock or ownership interests in Bellicum Pharmaceuticals, Mazor Robotics, TransEnterix, Inc, Amarin Corporation; has received honoraria from Bristol Myers Squibb, Sanofi; has acted in a consulting/advisory role for Bristol Myers Squibb, AstraZeneca, EMD Serono, Regeneron, HUYA Bioscience International, Genentech, Array BioPharma, Immunocore, Merck, Incyte, Jounce; and has received research funding from Bristol Myers Squibb, Celgene, Merck, Regeneron, HUYA Bioscience International, Novartis, GlaxoSmithKline, Amgen. A Diab has received honoraria from Nektar and Idera Pharmaceuticals; and has acted in a consulting/advisory role for and received research funding from Nektar, Idera Pharmaceuticals, Array BioPharma. PA Ascierto has acted in a consulting/advisory role for Bristol Myers Squibb, Roche/Genentech, MSD, Array BioPharma, Novartis, Merck/EMD Serono, Pierre Fabre, Incyte, Genmab, NewLink Genetics, MedImmune, AstraZeneca, Syndax, Sun Pharmaceutical, Sanofi, Idera Pharmaceuticals, Ultimovacs, Sandoz, Immunocore; has received research funding from Bristol Myers Squibb, Roche/Genentech, Array BioPharma; and has received compensation for travel, accommodations or expenses from MSD. J Larkin has received honoraria from and has acted in a consulting/advisory role for Achilles Therapeutics, AstraZeneca, Boston Biomedical, Bristol Myers Squibb, Eisai, EUSA Pharma, GlaxoSmithKline, Ipsen Pharma, Imugene, Incyte, iOnctura, Kymab, Merck/EMD Serono, MSD, Nektar, Novartis, Pierre Fabre, Pfizer, Roche, Secarna, Vitaccess; and has received research funding from Bristol Myers Squibb, MSD, Novartis, Pfizer, Achilles Therapeutics, Aveo, Roche, Nektar, Covance. S Sandhu has received honoraria from and acted in a consulting/advisory role for Bristol Myers Squibb, Merck, Merck/EMD Serono, Novartis, Roche/Genentech, Janssen; has been a member of the speakers' bureau for Bristol Myers Squibb, Merck, Merck/EMD Serono, Roche/Genentech; has received research funding from AstraZeneca, Bristol Myers Squibb, Merck, Merck/EMD Serono, Tolmar; and has received compensation for travel, accommodations or expenses from Bristol Myers Squibb, Roche/Genentech. M Sznol owns stock or has other ownership interests in Amphivena Therapeutics, Intensity Therapeutics, Adaptive Biotechnologies, Actym Therapeutics, Torque, NextCure; and has acted in a consulting/advisory role for Bristol Myers Squibb, Genentech/Roche, AstraZeneca/MedImmune, Kyowa Kirin, Nektar, Novartis, Eli Lilly and Company, MSD, Biodesix, Adaptimmune, Theravance Biopharma, Modulate Pharma, Omniox, Seattle Genetics, Inovio Pharmaceuticals, Pierre Fabre, NewLink Genetics, Molecular Partners, Genmab, Torque, AbbVie, Allakos, Hinge Health, Symphogen, Pieris Pharmaceuticals, Gritstone Oncology, Innate Pharma, Celldex Therapeutics, Incyte, Almac Diagnostic Services, Immunocore, Array BioPharma, Anaeropharma, GI Innovation, Genocea Biosciences, Chugai/Roche, Zelluna; other relationships include Haymarket Media, Research to Practice, TRM Oncology, Physicians Education Resource, Imedex, AcademicCME, DAVAOncology, Clinical Care Options, Vindico, Prime Oncology, CEC Oncology. GV Long has acted in a consulting/advisory role to Aduro Biotech, Amgen, Bristol Myers Squibb, Merck/MSD, Novartis, OncoSec Medical, Pierre Fabre, Roche; and has received research funding from Bristol Myers Squibb, Merck (MSD). A Jarkowski, HB Koon, P Statkevich, WJ Geese and M Zhou are employees of Bristol Myers Squibb.A Jarkowski, HB Koon, M Zhou, WJ Geese and P Statkevich own stock in Bristol Myers Squibb. A Jarkowski owns stock in AstraZeneca. P Statkevich owns stock in Merck. M Zhou has patents, royalties or other intellectual property with Bristol Myers Squibb. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Medical writing and editorial supportwere provided by SL Thier, J Kim and M Salernitano of Ashfield Healthcare Communications (NJ, USA), funded by Bristol-Myers Squibb Company.