REVOLUMAB: A phase II trial of nivolumab in recurrent IDH mutant high-grade gliomas
Novel effective treatments are needed for recurrent IDH mutant high-grade gliomas (IDHm HGGs). The aim of the multicentric, single-arm, phase II REVOLUMAB trial (NCT03925246) was to assess the efficacy and safety of the anti-PD1 Nivolumab in patients with recurrent IDHm HGGs. Adult patients with IDH...
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| Veröffentlicht in: | European journal of cancer (1990) 2024-05, Vol.202, p.114034-114034, Article 114034 |
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| creator | Picca, Alberto Touat, Mehdi Belin, Lisa Gourmelon, Carole Harlay, Vincent Cuzzubbo, Stefania Cohen-Jonathan Moyal, Elizabeth Bronnimann, Charlotte Di Stefano, Anna Luisa Laurent, Isaura Lerond, Julie Carpentier, Catherine Bielle, Franck Ducray, François Dehais, Caroline |
| description | Novel effective treatments are needed for recurrent IDH mutant high-grade gliomas (IDHm HGGs). The aim of the multicentric, single-arm, phase II REVOLUMAB trial (NCT03925246) was to assess the efficacy and safety of the anti-PD1 Nivolumab in patients with recurrent IDHm HGGs.
Adult patients with IDHm WHO grade 3–4 gliomas recurring after radiotherapy and ≥ 1 line of alkylating chemotherapy were treated with intravenous Nivolumab until end of treatment (12 months), progression, unacceptable toxicity, or death. The primary endpoint was the 24-week progression-free survival rate (24w-PFS) according to RANO criteria.
From July 2019 to June 2020, 39 patients with recurrent IDHm HGGs (twenty-one grade 3, thirteen grade 4, five grade 2 with radiological evidence of anaplastic transformation; 39% 1p/19q codeleted) were enrolled. Median time since diagnosis was 5.7 years, and the median number of previous systemic treatments was two. The 24w-PFS was 28.2% (11/39, CI95% 15–44.9%). Median PFS and OS were 1.84 (CI95% 1.81–5.89) and 14.7 months (CI95% 9.18-NR), respectively. Four patients (10.3%) achieved partial response according to RANO criteria. There were no significant differences in clinical or histomolecular features between responders and non-responders. The safety profile of Nivolumab was consistent with prior studies.
We report the results of the first trial of immune checkpoint inhibitors in IDHm gliomas. Nivolumab failed to achieve its primary endpoint. However, treatment was well tolerated, and long-lasting responses were observed in a subset of patients, supporting further evaluation in combination with other agents (e.g. IDH inhibitors).
•REVOLUMAB is the first phase II trial of checkpoint inhibitors in r/r IDHmut gliomas.•The trial did not meet its primary endpoint on the 24-week progression-free survival.•Nivolumab was well tolerated in patients with r/r IDHmut gliomas.•Long-lasting partial responses were observed in a subset of patients. |
| doi_str_mv | 10.1016/j.ejca.2024.114034 |
| format | Article |
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Adult patients with IDHm WHO grade 3–4 gliomas recurring after radiotherapy and ≥ 1 line of alkylating chemotherapy were treated with intravenous Nivolumab until end of treatment (12 months), progression, unacceptable toxicity, or death. The primary endpoint was the 24-week progression-free survival rate (24w-PFS) according to RANO criteria.
From July 2019 to June 2020, 39 patients with recurrent IDHm HGGs (twenty-one grade 3, thirteen grade 4, five grade 2 with radiological evidence of anaplastic transformation; 39% 1p/19q codeleted) were enrolled. Median time since diagnosis was 5.7 years, and the median number of previous systemic treatments was two. The 24w-PFS was 28.2% (11/39, CI95% 15–44.9%). Median PFS and OS were 1.84 (CI95% 1.81–5.89) and 14.7 months (CI95% 9.18-NR), respectively. Four patients (10.3%) achieved partial response according to RANO criteria. There were no significant differences in clinical or histomolecular features between responders and non-responders. The safety profile of Nivolumab was consistent with prior studies.
We report the results of the first trial of immune checkpoint inhibitors in IDHm gliomas. Nivolumab failed to achieve its primary endpoint. However, treatment was well tolerated, and long-lasting responses were observed in a subset of patients, supporting further evaluation in combination with other agents (e.g. IDH inhibitors).
•REVOLUMAB is the first phase II trial of checkpoint inhibitors in r/r IDHmut gliomas.•The trial did not meet its primary endpoint on the 24-week progression-free survival.•Nivolumab was well tolerated in patients with r/r IDHmut gliomas.•Long-lasting partial responses were observed in a subset of patients.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2024.114034</identifier><identifier>PMID: 38537315</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Brain Neoplasms - drug therapy ; Brain Neoplasms - genetics ; Cancer ; Clinical trial ; Cognitive science ; Glioma - drug therapy ; Glioma - genetics ; High-grade gliomas ; Human health and pathology ; Humans ; IDH ; Immunology ; Immunotherapy ; Life Sciences ; Neoplasm Recurrence, Local - drug therapy ; Neuroscience ; Nivolumab ; Nivolumab - therapeutic use ; Progression-Free Survival</subject><ispartof>European journal of cancer (1990), 2024-05, Vol.202, p.114034-114034, Article 114034</ispartof><rights>2024 Elsevier Ltd</rights><rights>Copyright © 2024 Elsevier Ltd. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c390t-27df3b1f6fc04441c4fd03f69c5d7fd1a4bc0554439af0eefe49f0e2934fb1e43</citedby><cites>FETCH-LOGICAL-c390t-27df3b1f6fc04441c4fd03f69c5d7fd1a4bc0554439af0eefe49f0e2934fb1e43</cites><orcidid>0000-0001-6564-6388 ; 0000-0001-8724-2704 ; 0000-0003-2910-4930 ; 0000-0003-0288-4607</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejca.2024.114034$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,315,781,785,886,3551,27929,27930,46000</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38537315$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.sorbonne-universite.fr/hal-04625395$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Picca, Alberto</creatorcontrib><creatorcontrib>Touat, Mehdi</creatorcontrib><creatorcontrib>Belin, Lisa</creatorcontrib><creatorcontrib>Gourmelon, Carole</creatorcontrib><creatorcontrib>Harlay, Vincent</creatorcontrib><creatorcontrib>Cuzzubbo, Stefania</creatorcontrib><creatorcontrib>Cohen-Jonathan Moyal, Elizabeth</creatorcontrib><creatorcontrib>Bronnimann, Charlotte</creatorcontrib><creatorcontrib>Di Stefano, Anna Luisa</creatorcontrib><creatorcontrib>Laurent, Isaura</creatorcontrib><creatorcontrib>Lerond, Julie</creatorcontrib><creatorcontrib>Carpentier, Catherine</creatorcontrib><creatorcontrib>Bielle, Franck</creatorcontrib><creatorcontrib>Ducray, François</creatorcontrib><creatorcontrib>Dehais, Caroline</creatorcontrib><creatorcontrib>POLA Network</creatorcontrib><title>REVOLUMAB: A phase II trial of nivolumab in recurrent IDH mutant high-grade gliomas</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Novel effective treatments are needed for recurrent IDH mutant high-grade gliomas (IDHm HGGs). The aim of the multicentric, single-arm, phase II REVOLUMAB trial (NCT03925246) was to assess the efficacy and safety of the anti-PD1 Nivolumab in patients with recurrent IDHm HGGs.
Adult patients with IDHm WHO grade 3–4 gliomas recurring after radiotherapy and ≥ 1 line of alkylating chemotherapy were treated with intravenous Nivolumab until end of treatment (12 months), progression, unacceptable toxicity, or death. The primary endpoint was the 24-week progression-free survival rate (24w-PFS) according to RANO criteria.
From July 2019 to June 2020, 39 patients with recurrent IDHm HGGs (twenty-one grade 3, thirteen grade 4, five grade 2 with radiological evidence of anaplastic transformation; 39% 1p/19q codeleted) were enrolled. Median time since diagnosis was 5.7 years, and the median number of previous systemic treatments was two. The 24w-PFS was 28.2% (11/39, CI95% 15–44.9%). Median PFS and OS were 1.84 (CI95% 1.81–5.89) and 14.7 months (CI95% 9.18-NR), respectively. Four patients (10.3%) achieved partial response according to RANO criteria. There were no significant differences in clinical or histomolecular features between responders and non-responders. The safety profile of Nivolumab was consistent with prior studies.
We report the results of the first trial of immune checkpoint inhibitors in IDHm gliomas. Nivolumab failed to achieve its primary endpoint. However, treatment was well tolerated, and long-lasting responses were observed in a subset of patients, supporting further evaluation in combination with other agents (e.g. IDH inhibitors).
•REVOLUMAB is the first phase II trial of checkpoint inhibitors in r/r IDHmut gliomas.•The trial did not meet its primary endpoint on the 24-week progression-free survival.•Nivolumab was well tolerated in patients with r/r IDHmut gliomas.•Long-lasting partial responses were observed in a subset of patients.</description><subject>Adult</subject><subject>Brain Neoplasms - drug therapy</subject><subject>Brain Neoplasms - genetics</subject><subject>Cancer</subject><subject>Clinical trial</subject><subject>Cognitive science</subject><subject>Glioma - drug therapy</subject><subject>Glioma - genetics</subject><subject>High-grade gliomas</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>IDH</subject><subject>Immunology</subject><subject>Immunotherapy</subject><subject>Life Sciences</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neuroscience</subject><subject>Nivolumab</subject><subject>Nivolumab - therapeutic use</subject><subject>Progression-Free Survival</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1vEzEURS1UREPhD3RReVkWE57HdmaM2IRSSKSgSi3t1vJ4nhNH8xHsmUj8exxN2yWr-_R07l0cQi4ZzBmwxef9HPfWzHPIxZwxAVy8ITNWFiqDUuZnZAZKqqwEoc7J-xj3AFCUAt6Rc15KXnAmZ-Th_vbpbvP4a_ntC13Sw85EpOs1HYI3De0d7fyxb8bWVNR3NKAdQ8BuoOvvK9qOg0nnzm932TaYGum28X1r4gfy1pkm4sfnvCCPP25_36yyzd3P9c1yk1muYMjyona8Ym7hLAghmBWuBu4Wysq6cDUzorIgpRBcGQeIDoVKmSsuXMVQ8AvyadrdmUYfgm9N-Kt74_VqudGnH4hFLrmSR5bY64k9hP7PiHHQrY8Wm8Z02I9Rc0gCWc5AJTSfUBv6GAO6120G-iRe7_VJvD6J15P4VLp63h-rFuvXyovpBHydAExGjh6DjtZjZ7H2Seug697_b_8fiFuRWw</recordid><startdate>20240501</startdate><enddate>20240501</enddate><creator>Picca, Alberto</creator><creator>Touat, Mehdi</creator><creator>Belin, Lisa</creator><creator>Gourmelon, Carole</creator><creator>Harlay, Vincent</creator><creator>Cuzzubbo, Stefania</creator><creator>Cohen-Jonathan Moyal, Elizabeth</creator><creator>Bronnimann, Charlotte</creator><creator>Di Stefano, Anna Luisa</creator><creator>Laurent, Isaura</creator><creator>Lerond, Julie</creator><creator>Carpentier, Catherine</creator><creator>Bielle, Franck</creator><creator>Ducray, François</creator><creator>Dehais, Caroline</creator><general>Elsevier Ltd</general><general>Elsevier</general><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><scope>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0001-6564-6388</orcidid><orcidid>https://orcid.org/0000-0001-8724-2704</orcidid><orcidid>https://orcid.org/0000-0003-2910-4930</orcidid><orcidid>https://orcid.org/0000-0003-0288-4607</orcidid></search><sort><creationdate>20240501</creationdate><title>REVOLUMAB: A phase II trial of nivolumab in recurrent IDH mutant high-grade gliomas</title><author>Picca, Alberto ; 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The aim of the multicentric, single-arm, phase II REVOLUMAB trial (NCT03925246) was to assess the efficacy and safety of the anti-PD1 Nivolumab in patients with recurrent IDHm HGGs.
Adult patients with IDHm WHO grade 3–4 gliomas recurring after radiotherapy and ≥ 1 line of alkylating chemotherapy were treated with intravenous Nivolumab until end of treatment (12 months), progression, unacceptable toxicity, or death. The primary endpoint was the 24-week progression-free survival rate (24w-PFS) according to RANO criteria.
From July 2019 to June 2020, 39 patients with recurrent IDHm HGGs (twenty-one grade 3, thirteen grade 4, five grade 2 with radiological evidence of anaplastic transformation; 39% 1p/19q codeleted) were enrolled. Median time since diagnosis was 5.7 years, and the median number of previous systemic treatments was two. The 24w-PFS was 28.2% (11/39, CI95% 15–44.9%). Median PFS and OS were 1.84 (CI95% 1.81–5.89) and 14.7 months (CI95% 9.18-NR), respectively. Four patients (10.3%) achieved partial response according to RANO criteria. There were no significant differences in clinical or histomolecular features between responders and non-responders. The safety profile of Nivolumab was consistent with prior studies.
We report the results of the first trial of immune checkpoint inhibitors in IDHm gliomas. Nivolumab failed to achieve its primary endpoint. However, treatment was well tolerated, and long-lasting responses were observed in a subset of patients, supporting further evaluation in combination with other agents (e.g. IDH inhibitors).
•REVOLUMAB is the first phase II trial of checkpoint inhibitors in r/r IDHmut gliomas.•The trial did not meet its primary endpoint on the 24-week progression-free survival.•Nivolumab was well tolerated in patients with r/r IDHmut gliomas.•Long-lasting partial responses were observed in a subset of patients.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>38537315</pmid><doi>10.1016/j.ejca.2024.114034</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-6564-6388</orcidid><orcidid>https://orcid.org/0000-0001-8724-2704</orcidid><orcidid>https://orcid.org/0000-0003-2910-4930</orcidid><orcidid>https://orcid.org/0000-0003-0288-4607</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | European journal of cancer (1990), 2024-05, Vol.202, p.114034-114034, Article 114034 |
| issn | 0959-8049 1879-0852 |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Adult Brain Neoplasms - drug therapy Brain Neoplasms - genetics Cancer Clinical trial Cognitive science Glioma - drug therapy Glioma - genetics High-grade gliomas Human health and pathology Humans IDH Immunology Immunotherapy Life Sciences Neoplasm Recurrence, Local - drug therapy Neuroscience Nivolumab Nivolumab - therapeutic use Progression-Free Survival |
| title | REVOLUMAB: A phase II trial of nivolumab in recurrent IDH mutant high-grade gliomas |
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