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 |
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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.
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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 |
format | Article |
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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.</description><identifier>ISSN: 1479-6694</identifier><identifier>EISSN: 1744-8301</identifier><identifier>DOI: 10.2217/fon-2022-0802</identifier><identifier>PMID: 36752726</identifier><language>eng</language><publisher>England: Future Medicine Ltd</publisher><subject>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</subject><ispartof>Future oncology (London, England), 2023-01, Vol.19 (2), p.113-121</ispartof><rights>2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates and Robert J Motzer, Manuela Schmidnger, Masatoshi Eto, Christina Suarez, Robert Figlin, Daniel YC Heng</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c382t-41adf4b09e2da95136e5a031c5f54db2f0483e96464392b32a0c622c8d714c0b3</citedby><cites>FETCH-LOGICAL-c382t-41adf4b09e2da95136e5a031c5f54db2f0483e96464392b32a0c622c8d714c0b3</cites><orcidid>0000-0001-6925-2327</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36752726$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Motzer, Robert J</creatorcontrib><creatorcontrib>Schmidinger, Manuela</creatorcontrib><creatorcontrib>Eto, Masatoshi</creatorcontrib><creatorcontrib>Suarez, Cristina</creatorcontrib><creatorcontrib>Figlin, Robert</creatorcontrib><creatorcontrib>Liu, Yanfang</creatorcontrib><creatorcontrib>Perini, Rodolfo</creatorcontrib><creatorcontrib>Zhang, Yayan</creatorcontrib><creatorcontrib>Heng, Daniel Yc</creatorcontrib><title>LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy</title><title>Future oncology (London, England)</title><addtitle>Future Oncol</addtitle><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.
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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.</description><subject>B7-H1 Antigen</subject><subject>Basic Helix-Loop-Helix Transcription Factors</subject><subject>Carcinoma, Renal Cell - pathology</subject><subject>clear cell renal cell carcinoma</subject><subject>HIF-2α inhibitor</subject><subject>Humans</subject><subject>immune checkpoint inhibitor</subject><subject>Kidney Neoplasms - pathology</subject><subject>metastatic</subject><subject>PD-1/PD-L1 inhibitor</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><issn>1479-6694</issn><issn>1744-8301</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kEtv1TAQRi0EoqVl2W3lJRtTvxIn7Ko-oOJKVLSsrYkzVl3lOhc7uWr763GUwo7NPKQzn0aHkBPBP0spzJkfI5NcSsYbLt-QQ2G0Zo3i4m2ZtWlZXbf6gHzI-ZFzbVTF35MDVZtKGlkfkqfNzf3V3e35z--MC_GFdji8zFPwEOlumDMdMO5hCjF0dJ-pg258gbjuIVLo9xAd9jRhhIE6HEqB5EIct0DBT5jogrPbSybOStkIOj1ggt3zMXnnYcj48bUfkV_XV_cX39jmx9ebi_MNc6qRE9MCeq873qLsoa2EqrECroSrfKX7TnquG4VtrWutWtkpCdzVUrqmN0I73qkj8mnN3aXx94x5stuQl0ch4jhnK00R1prKyIKyFXVpzDmht7sUtpCereB2kW2LbLvItovswp--Rs_dFvt_9F-7BWhXwM_TnDC7gMWWXbdyEYoo_E_4H7XbjJQ</recordid><startdate>20230101</startdate><enddate>20230101</enddate><creator>Motzer, Robert J</creator><creator>Schmidinger, Manuela</creator><creator>Eto, Masatoshi</creator><creator>Suarez, Cristina</creator><creator>Figlin, Robert</creator><creator>Liu, Yanfang</creator><creator>Perini, Rodolfo</creator><creator>Zhang, Yayan</creator><creator>Heng, Daniel Yc</creator><general>Future Medicine Ltd</general><scope>FUMOA</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6925-2327</orcidid></search><sort><creationdate>20230101</creationdate><title>LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy</title><author>Motzer, Robert J ; Schmidinger, Manuela ; Eto, Masatoshi ; Suarez, Cristina ; Figlin, Robert ; Liu, Yanfang ; Perini, Rodolfo ; Zhang, Yayan ; Heng, Daniel Yc</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c382t-41adf4b09e2da95136e5a031c5f54db2f0483e96464392b32a0c622c8d714c0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>B7-H1 Antigen</topic><topic>Basic Helix-Loop-Helix Transcription Factors</topic><topic>Carcinoma, Renal Cell - pathology</topic><topic>clear cell renal cell carcinoma</topic><topic>HIF-2α inhibitor</topic><topic>Humans</topic><topic>immune checkpoint inhibitor</topic><topic>Kidney Neoplasms - pathology</topic><topic>metastatic</topic><topic>PD-1/PD-L1 inhibitor</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Motzer, Robert J</creatorcontrib><creatorcontrib>Schmidinger, Manuela</creatorcontrib><creatorcontrib>Eto, Masatoshi</creatorcontrib><creatorcontrib>Suarez, Cristina</creatorcontrib><creatorcontrib>Figlin, Robert</creatorcontrib><creatorcontrib>Liu, Yanfang</creatorcontrib><creatorcontrib>Perini, Rodolfo</creatorcontrib><creatorcontrib>Zhang, Yayan</creatorcontrib><creatorcontrib>Heng, Daniel Yc</creatorcontrib><collection>Future Medicine (Open Access)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Future oncology (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Motzer, Robert J</au><au>Schmidinger, Manuela</au><au>Eto, Masatoshi</au><au>Suarez, Cristina</au><au>Figlin, Robert</au><au>Liu, Yanfang</au><au>Perini, Rodolfo</au><au>Zhang, Yayan</au><au>Heng, Daniel Yc</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy</atitle><jtitle>Future oncology (London, England)</jtitle><addtitle>Future Oncol</addtitle><date>2023-01-01</date><risdate>2023</risdate><volume>19</volume><issue>2</issue><spage>113</spage><epage>121</epage><pages>113-121</pages><issn>1479-6694</issn><eissn>1744-8301</eissn><abstract>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.
(
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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.</abstract><cop>England</cop><pub>Future Medicine Ltd</pub><pmid>36752726</pmid><doi>10.2217/fon-2022-0802</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-6925-2327</orcidid><oa>free_for_read</oa></addata></record> |
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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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