PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence

Alexander Mm Eggermont; Paolo A. Ascierto; Nikhil I. Khushalani; Dirk Schadendorf; Genevieve Boland; Jeffrey Weber; Karl D. Lewis; Daniel Johnson; Gareth Rivalland; Adnan Khattak; Margarita Majem; Helen Gogas; Georgina V. Long; Sue L. Currie; David Chien; Mary A. Tagliaferri; Matteo S. Carlino; Adi Diab

doi:10.2217/fon-2021-1286

PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence

Alexander Mm Eggermont, Paolo A. Ascierto, Nikhil I. Khushalani, Dirk Schadendorf, Genevieve Boland, Jeffrey Weber, Karl D. Lewis, Daniel Johnson, Gareth Rivalland, Adnan Khattak, Margarita Majem, Helen Gogas, Georgina V. Long, Sue L. Currie, David Chien, Mary A. Tagliaferri, Matteo S. Carlino, Adi Diab

Melanoma Medical Oncology

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

Abstract

Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.

Original language	English (US)
Pages (from-to)	903-913
Number of pages	11
Journal	Future oncology (London, England)
Volume	18
Issue number	8
DOIs	https://doi.org/10.2217/fon-2021-1286
State	Published - Mar 1 2022

Keywords

IL-2 pathway
NKTR-214
PD-1
PD-L1
adjuvant
bempegaldesleukin
cutaneous melanoma
immune checkpoint inhibitor combinations
immunotherapy
nivolumab

ASJC Scopus subject areas

Oncology
Cancer Research

Access to Document

10.2217/fon-2021-1286

Cite this

Eggermont, A. M., Ascierto, P. A., Khushalani, N. I., Schadendorf, D., Boland, G., Weber, J., Lewis, K. D., Johnson, D., Rivalland, G., Khattak, A., Majem, M., Gogas, H., Long, G. V., Currie, S. L., Chien, D., Tagliaferri, M. A., Carlino, M. S., & Diab, A. (2022). PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence. Future oncology (London, England), 18(8), 903-913. https://doi.org/10.2217/fon-2021-1286

Eggermont, AM, Ascierto, PA, Khushalani, NI, Schadendorf, D, Boland, G, Weber, J, Lewis, KD, Johnson, D, Rivalland, G, Khattak, A, Majem, M, Gogas, H, Long, GV, Currie, SL, Chien, D, Tagliaferri, MA, Carlino, MS & Diab, A 2022, 'PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence', Future oncology (London, England), vol. 18, no. 8, pp. 903-913. https://doi.org/10.2217/fon-2021-1286

@article{2ffa7ad28b884ba799d7e4e65ac15ab2,

title = "PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence",

abstract = "Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.",

keywords = "IL-2 pathway, NKTR-214, PD-1, PD-L1, adjuvant, bempegaldesleukin, cutaneous melanoma, immune checkpoint inhibitor combinations, immunotherapy, nivolumab",

author = "Eggermont, {Alexander Mm} and Ascierto, {Paolo A.} and Khushalani, {Nikhil I.} and Dirk Schadendorf and Genevieve Boland and Jeffrey Weber and Lewis, {Karl D.} and Daniel Johnson and Gareth Rivalland and Adnan Khattak and Margarita Majem and Helen Gogas and Long, {Georgina V.} and Currie, {Sue L.} and David Chien and Tagliaferri, {Mary A.} and Carlino, {Matteo S.} and Adi Diab",

year = "2022",

month = mar,

day = "1",

doi = "10.2217/fon-2021-1286",

language = "English (US)",

volume = "18",

pages = "903--913",

journal = "Future oncology (London, England)",

issn = "1479-6694",

publisher = "Taylor and Francis Ltd.",

number = "8",

}

TY - JOUR

T1 - PIVOT-12

T2 - a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence

AU - Eggermont, Alexander Mm

AU - Ascierto, Paolo A.

AU - Khushalani, Nikhil I.

AU - Schadendorf, Dirk

AU - Boland, Genevieve

AU - Weber, Jeffrey

AU - Lewis, Karl D.

AU - Johnson, Daniel

AU - Rivalland, Gareth

AU - Khattak, Adnan

AU - Majem, Margarita

AU - Gogas, Helen

AU - Long, Georgina V.

AU - Currie, Sue L.

AU - Chien, David

AU - Tagliaferri, Mary A.

AU - Carlino, Matteo S.

AU - Diab, Adi

PY - 2022/3/1

Y1 - 2022/3/1

N2 - Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.

AB - Bempegaldesleukin (BEMPEG: NKTR-214) is an immunostimulatory IL-2 cytokine prodrug engineered to deliver a controlled, sustained and preferential IL-2 pathway signal. Nivolumab (NIVO), a PD-1 inhibitor, has been shown to prolong survival in patients with advanced melanoma and recurrence-free survival in the adjuvant setting. PIVOT-02 showed that BEMPEG plus NIVO was well-tolerated and demonstrated clinical activity as first-line therapy in metastatic melanoma. PIVOT-12 is a randomized, phase III, global, multicenter, open-label study comparing adjuvant therapy with BEMPEG plus NIVO versus NIVO alone in adult and adolescent patients with completely resected cutaneous stage III/IV melanoma at high risk of recurrence. The primary objective is to compare the efficacy, as measured by recurrence-free survival, of BEMPEG plus NIVO versus NIVO.

KW - IL-2 pathway

KW - NKTR-214

KW - PD-1

KW - PD-L1

KW - adjuvant

KW - bempegaldesleukin

KW - cutaneous melanoma

KW - immune checkpoint inhibitor combinations

KW - immunotherapy

KW - nivolumab

UR - http://www.scopus.com/inward/record.url?scp=85125554158&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85125554158&partnerID=8YFLogxK

U2 - 10.2217/fon-2021-1286

DO - 10.2217/fon-2021-1286

M3 - Article

C2 - 35073733

AN - SCOPUS:85125554158

SN - 1479-6694

VL - 18

SP - 903

EP - 913

JO - Future oncology (London, England)

JF - Future oncology (London, England)

IS - 8

ER -