LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy

The first-in-class, small molecule HIF-2α inhibitor, belzutifan, has demonstrated promising antitumor activity in previously treated patients with clear cell renal cell carcinoma (RCC). HIF-2α also regulates VEGF expression and is involved in resistance to anti-VEGF therapy. This study describes the...

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Veröffentlicht in:Future oncology (London, England) England), 2023-01, Vol.19 (2), p.113-121
Hauptverfasser: Motzer, Robert J, Schmidinger, Manuela, Eto, Masatoshi, Suarez, Cristina, Figlin, Robert, Liu, Yanfang, Perini, Rodolfo, Zhang, Yayan, Heng, Daniel Yc
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container_end_page 121
container_issue 2
container_start_page 113
container_title Future oncology (London, England)
container_volume 19
creator Motzer, Robert J
Schmidinger, Manuela
Eto, Masatoshi
Suarez, Cristina
Figlin, Robert
Liu, Yanfang
Perini, Rodolfo
Zhang, Yayan
Heng, Daniel Yc
description The first-in-class, small molecule HIF-2α inhibitor, belzutifan, has demonstrated promising antitumor activity in previously treated patients with clear cell renal cell carcinoma (RCC). HIF-2α also regulates VEGF expression and is involved in resistance to anti-VEGF therapy. This study describes the rationale and design for a randomized, phase III study evaluating efficacy and safety of belzutifan plus the tyrosine kinase inhibitor (TKI) lenvatinib versus the TKI cabozantinib in patients with advanced RCC progressing after anti-PD-1/PD-L1 therapy in the first- or second-line setting or as adjuvant therapy. Considering the unmet need for effective and tolerable treatment of advanced RCC following immune checkpoint inhibitors, belzutifan plus lenvatinib may have a positive benefit/risk profile. ( ) The phase III LITESPARK-011 study will evaluate efficacy and safety of the HIF-2α inhibitor belzutifan plus lenvatinib versus cabozantinib in patients with advanced RCC progressing after anti-PD-1/PD-L1 therapy.
doi_str_mv 10.2217/fon-2022-0802
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subjects B7-H1 Antigen
Basic Helix-Loop-Helix Transcription Factors
Carcinoma, Renal Cell - pathology
clear cell renal cell carcinoma
HIF-2α inhibitor
Humans
immune checkpoint inhibitor
Kidney Neoplasms - pathology
metastatic
PD-1/PD-L1 inhibitor
Protein Kinase Inhibitors - adverse effects
title LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy
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