PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer

Robert A. Huddart; Arlene O. Siefker-Radtke; Arjun V. Balar; Mehmet A. Bilen; Thomas Powles; Aristotelis Bamias; Daniel Castellano; Maged F. Khalil; Michiel S. Van Der Heijden; Vadim S. Koshkin; David W. Pook; Mustafa Ozguroglu; Linda Santiago; Bob Zhong; David Chien; Wei Lin; Mary A. Tagliaferri; Yohann Loriot

doi:10.2217/fon-2020-0795

PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer

Robert A. Huddart, Arlene O. Siefker-Radtke, Arjun V. Balar, Mehmet A. Bilen, Thomas Powles, Aristotelis Bamias, Daniel Castellano, Maged F. Khalil, Michiel S. Van Der Heijden, Vadim S. Koshkin, David W. Pook, Mustafa Ozguroglu, Linda Santiago, Bob Zhong, David Chien, Wei Lin, Mary A. Tagliaferri, Yohann Loriot

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Résumé

The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and-negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).

langue originale	Anglais
Pages (de - à)	137-149
Nombre de pages	13
journal	Future Oncology
Volume	17
Numéro de publication	2
Les DOIs	https://doi.org/10.2217/fon-2020-0795
état	Publié - 1 janv. 2021

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10.2217/fon-2020-0795

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Huddart, R. A., Siefker-Radtke, A. O., Balar, A. V., Bilen, M. A., Powles, T., Bamias, A., Castellano, D., Khalil, M. F., Van Der Heijden, M. S., Koshkin, V. S., Pook, D. W., Ozguroglu, M., Santiago, L., Zhong, B., Chien, D., Lin, W., Tagliaferri, M. A., & Loriot, Y. (2021). PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer. Future Oncology, 17(2), 137-149. https://doi.org/10.2217/fon-2020-0795

@article{12f326907a764714b33e9bafade59b38,

title = "PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer",

abstract = "The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and-negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).",

keywords = "IL-2 pathway, NKTR-214, PD-L1, PD-L1 negative, bempegaldesleukin, cisplatin-ineligible, immune checkpoint inhibitor combinations, immunotherapy, metastatic urothelial cancer, nivolumab",

author = "Huddart, {Robert A.} and Siefker-Radtke, {Arlene O.} and Balar, {Arjun V.} and Bilen, {Mehmet A.} and Thomas Powles and Aristotelis Bamias and Daniel Castellano and Khalil, {Maged F.} and {Van Der Heijden}, {Michiel S.} and Koshkin, {Vadim S.} and Pook, {David W.} and Mustafa Ozguroglu and Linda Santiago and Bob Zhong and David Chien and Wei Lin and Tagliaferri, {Mary A.} and Yohann Loriot",

note = "Publisher Copyright: {\textcopyright} 2020 Robert A Huddart and co-authors.",

year = "2021",

month = jan,

day = "1",

doi = "10.2217/fon-2020-0795",

language = "English",

volume = "17",

pages = "137--149",

journal = "Future Oncology",

issn = "1479-6694",

number = "2",

}

Huddart, RA, Siefker-Radtke, AO, Balar, AV, Bilen, MA, Powles, T, Bamias, A, Castellano, D, Khalil, MF, Van Der Heijden, MS, Koshkin, VS, Pook, DW, Ozguroglu, M, Santiago, L, Zhong, B, Chien, D, Lin, W, Tagliaferri, MA & Loriot, Y 2021, 'PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer', Future Oncology, VOL. 17, Numéro 2, p. 137-149. https://doi.org/10.2217/fon-2020-0795

TY - JOUR

T1 - PIVOT-10

T2 - Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer

AU - Huddart, Robert A.

AU - Siefker-Radtke, Arlene O.

AU - Balar, Arjun V.

AU - Bilen, Mehmet A.

AU - Powles, Thomas

AU - Bamias, Aristotelis

AU - Castellano, Daniel

AU - Khalil, Maged F.

AU - Van Der Heijden, Michiel S.

AU - Koshkin, Vadim S.

AU - Pook, David W.

AU - Ozguroglu, Mustafa

AU - Santiago, Linda

AU - Zhong, Bob

AU - Chien, David

AU - Lin, Wei

AU - Tagliaferri, Mary A.

AU - Loriot, Yohann

PY - 2021/1/1

Y1 - 2021/1/1

N2 - The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and-negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).

AB - The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and-negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).

KW - IL-2 pathway

KW - NKTR-214

KW - PD-L1

KW - PD-L1 negative

KW - bempegaldesleukin

KW - cisplatin-ineligible

KW - immune checkpoint inhibitor combinations

KW - immunotherapy

KW - metastatic urothelial cancer

KW - nivolumab

UR - http://www.scopus.com/inward/record.url?scp=85099858573&partnerID=8YFLogxK

U2 - 10.2217/fon-2020-0795

DO - 10.2217/fon-2020-0795

M3 - Article

C2 - 32938232

AN - SCOPUS:85099858573

SN - 1479-6694

VL - 17

SP - 137

EP - 149

JO - Future Oncology

JF - Future Oncology

IS - 2

ER -