Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651
CheckMate 651 (ClinicalTrials.gov identifier: NCT02741570) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil ≤ six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)....
Gespeichert in:
| Veröffentlicht in: | Journal of clinical oncology 2023-04, Vol.41 (12), p.2166-2180 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 2180 |
|---|---|
| container_issue | 12 |
| container_start_page | 2166 |
| container_title | Journal of clinical oncology |
| container_volume | 41 |
| creator | Haddad, Robert I Harrington, Kevin Tahara, Makoto Ferris, Robert L Gillison, Maura Fayette, Jerome Daste, Amaury Koralewski, Piotr Zurawski, Bogdan Taberna, Miren Saba, Nabil F Mak, Milena Kawecki, Andrzej Girotto, Gustavo Alvarez Avitia, Miguel Angel Even, Caroline Toledo, Joaquin Gabriel Reinoso Guminski, Alexander Müller-Richter, Urs Kiyota, Naomi Roberts, Mustimbo Khan, Tariq Aziz Miller-Moslin, Karen Wei, Li Argiris, Athanassios |
| description | CheckMate 651 (ClinicalTrials.gov identifier: NCT02741570) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil ≤ six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Patients without prior systemic therapy for R/M SCCHN were randomly assigned 1:1 to nivolumab plus ipilimumab or EXTREME. Primary end points were overall survival (OS) in the all randomly assigned and programmed death-ligand 1 combined positive score (CPS) ≥ 20 populations. Secondary end points included OS in the programmed death-ligand 1 CPS ≥ 1 population, and progression-free survival, objective response rate, and duration of response in the all randomly assigned and CPS ≥ 20 populations.
Among 947 patients randomly assigned, 38.3% had CPS ≥ 20. There were no statistically significant differences in OS with nivolumab plus ipilimumab versus EXTREME in the all randomly assigned (median: 13.9
13.5 months; hazard ratio [HR], 0.95; 97.9% CI, 0.80 to 1.13;
= .4951) and CPS ≥ 20 (median: 17.6
14.6 months; HR, 0.78; 97.51% CI, 0.59 to 1.03;
= .0469) populations. In patients with CPS ≥ 1, the median OS was 15.7 versus 13.2 months (HR, 0.82; 95% CI, 0.69 to 0.97). Among patients with CPS ≥ 20, the median progression-free survival was 5.4 months (nivolumab plus ipilimumab) versus 7.0 months (EXTREME), objective response rate was 34.1% versus 36.0%, and median duration of response was 32.6 versus 7.0 months. Grade 3/4 treatment-related adverse events occurred in 28.2% of patients treated with nivolumab plus ipilimumab versus 70.7% treated with EXTREME.
CheckMate 651 did not meet its primary end points of OS in the all randomly assigned or CPS ≥ 20 populations. Nivolumab plus ipilimumab showed a favorable safety profile compared with EXTREME. There continues to be a need for new therapies in patients with R/M SCCHN. |
| doi_str_mv | 10.1200/JCO.22.00332 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10115555</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2774347761</sourcerecordid><originalsourceid>FETCH-LOGICAL-c494t-6d77af4d6cfa7de2bd9c00992bd8be2c6c3c5e957b514708d1d901d1cc98600b3</originalsourceid><addsrcrecordid>eNpVkUtv1DAUhS0EokNhxxp5yYJM_UjiCRuEohlaNNOiMqDurBv7pmPIY2o7lfq3-gtxH1TgjX3P_XRs30PIW87mXDB29LU-mwsxZ0xK8YzMeCFUplRRPCczpqTI-EJeHJBXIfxijOcLWbwkB7LMleS5nJHbU3c9dlMPDf3WTYGe7F3n-vv6J_qQlOXF9ny5WdJzvHQ9DhQCXTkfYrZ2A9KtR4hJjrQdfWLM5H2qjjYYIUSIztDvVxP0Y3KqsetoDd64YeyBji2NO6THCJbCYOkpmt8f6TZJKzdAl8zC1MVwx9W71NtARFoW_DV50UIX8M3jfkh-rJbb-jhbn305qT-vM5NXecxKqxS0uS1NC8qiaGxlGKuqdFg0KExppCmwKlRT8FyxheW2YtxyY6pFyVgjD8mnB9_91PRoTfqWh07vvevB3-gRnP6_M7idvhyvNWecF2klh_ePDn68mjBE3btg0hRgwDQQLZTKZa5UyRP64QE1fgzBY_t0D2f6LmedctZC6PucE_7u37c9wX-DlX8AABGlhQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2774347761</pqid></control><display><type>article</type><title>Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651</title><source>MEDLINE</source><source>American Society of Clinical Oncology</source><source>Alma/SFX Local Collection</source><source>EZB Electronic Journals Library</source><creator>Haddad, Robert I ; Harrington, Kevin ; Tahara, Makoto ; Ferris, Robert L ; Gillison, Maura ; Fayette, Jerome ; Daste, Amaury ; Koralewski, Piotr ; Zurawski, Bogdan ; Taberna, Miren ; Saba, Nabil F ; Mak, Milena ; Kawecki, Andrzej ; Girotto, Gustavo ; Alvarez Avitia, Miguel Angel ; Even, Caroline ; Toledo, Joaquin Gabriel Reinoso ; Guminski, Alexander ; Müller-Richter, Urs ; Kiyota, Naomi ; Roberts, Mustimbo ; Khan, Tariq Aziz ; Miller-Moslin, Karen ; Wei, Li ; Argiris, Athanassios</creator><creatorcontrib>Haddad, Robert I ; Harrington, Kevin ; Tahara, Makoto ; Ferris, Robert L ; Gillison, Maura ; Fayette, Jerome ; Daste, Amaury ; Koralewski, Piotr ; Zurawski, Bogdan ; Taberna, Miren ; Saba, Nabil F ; Mak, Milena ; Kawecki, Andrzej ; Girotto, Gustavo ; Alvarez Avitia, Miguel Angel ; Even, Caroline ; Toledo, Joaquin Gabriel Reinoso ; Guminski, Alexander ; Müller-Richter, Urs ; Kiyota, Naomi ; Roberts, Mustimbo ; Khan, Tariq Aziz ; Miller-Moslin, Karen ; Wei, Li ; Argiris, Athanassios</creatorcontrib><description>CheckMate 651 (ClinicalTrials.gov identifier: NCT02741570) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil ≤ six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Patients without prior systemic therapy for R/M SCCHN were randomly assigned 1:1 to nivolumab plus ipilimumab or EXTREME. Primary end points were overall survival (OS) in the all randomly assigned and programmed death-ligand 1 combined positive score (CPS) ≥ 20 populations. Secondary end points included OS in the programmed death-ligand 1 CPS ≥ 1 population, and progression-free survival, objective response rate, and duration of response in the all randomly assigned and CPS ≥ 20 populations.
Among 947 patients randomly assigned, 38.3% had CPS ≥ 20. There were no statistically significant differences in OS with nivolumab plus ipilimumab versus EXTREME in the all randomly assigned (median: 13.9
13.5 months; hazard ratio [HR], 0.95; 97.9% CI, 0.80 to 1.13;
= .4951) and CPS ≥ 20 (median: 17.6
14.6 months; HR, 0.78; 97.51% CI, 0.59 to 1.03;
= .0469) populations. In patients with CPS ≥ 1, the median OS was 15.7 versus 13.2 months (HR, 0.82; 95% CI, 0.69 to 0.97). Among patients with CPS ≥ 20, the median progression-free survival was 5.4 months (nivolumab plus ipilimumab) versus 7.0 months (EXTREME), objective response rate was 34.1% versus 36.0%, and median duration of response was 32.6 versus 7.0 months. Grade 3/4 treatment-related adverse events occurred in 28.2% of patients treated with nivolumab plus ipilimumab versus 70.7% treated with EXTREME.
CheckMate 651 did not meet its primary end points of OS in the all randomly assigned or CPS ≥ 20 populations. Nivolumab plus ipilimumab showed a favorable safety profile compared with EXTREME. There continues to be a need for new therapies in patients with R/M SCCHN.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.22.00332</identifier><identifier>PMID: 36473143</identifier><language>eng</language><publisher>United States: Wolters Kluwer Health</publisher><subject>Antineoplastic Agents, Immunological - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Carcinoma, Squamous Cell - drug therapy ; Cetuximab ; Head and Neck Neoplasms - drug therapy ; Humans ; Ipilimumab - adverse effects ; Neoplasm Recurrence, Local - etiology ; Nivolumab - adverse effects ; ORIGINAL REPORTS ; Squamous Cell Carcinoma of Head and Neck - drug therapy</subject><ispartof>Journal of clinical oncology, 2023-04, Vol.41 (12), p.2166-2180</ispartof><rights>2022 by American Society of Clinical Oncology 2022 American Society of Clinical Oncology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-6d77af4d6cfa7de2bd9c00992bd8be2c6c3c5e957b514708d1d901d1cc98600b3</citedby><cites>FETCH-LOGICAL-c494t-6d77af4d6cfa7de2bd9c00992bd8be2c6c3c5e957b514708d1d901d1cc98600b3</cites><orcidid>0000-0002-6014-348X ; 0000-0003-1413-0079 ; 0000-0002-4098-1320 ; 0000-0001-5876-6533 ; 0000-0001-8021-6116 ; 0000-0003-4075-8812 ; 0000-0001-9035-3106 ; 0000-0003-4972-1477 ; 0000-0003-3681-7015 ; 0000-0001-7869-7686 ; 0000-0001-6605-2071</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,3716,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36473143$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Haddad, Robert I</creatorcontrib><creatorcontrib>Harrington, Kevin</creatorcontrib><creatorcontrib>Tahara, Makoto</creatorcontrib><creatorcontrib>Ferris, Robert L</creatorcontrib><creatorcontrib>Gillison, Maura</creatorcontrib><creatorcontrib>Fayette, Jerome</creatorcontrib><creatorcontrib>Daste, Amaury</creatorcontrib><creatorcontrib>Koralewski, Piotr</creatorcontrib><creatorcontrib>Zurawski, Bogdan</creatorcontrib><creatorcontrib>Taberna, Miren</creatorcontrib><creatorcontrib>Saba, Nabil F</creatorcontrib><creatorcontrib>Mak, Milena</creatorcontrib><creatorcontrib>Kawecki, Andrzej</creatorcontrib><creatorcontrib>Girotto, Gustavo</creatorcontrib><creatorcontrib>Alvarez Avitia, Miguel Angel</creatorcontrib><creatorcontrib>Even, Caroline</creatorcontrib><creatorcontrib>Toledo, Joaquin Gabriel Reinoso</creatorcontrib><creatorcontrib>Guminski, Alexander</creatorcontrib><creatorcontrib>Müller-Richter, Urs</creatorcontrib><creatorcontrib>Kiyota, Naomi</creatorcontrib><creatorcontrib>Roberts, Mustimbo</creatorcontrib><creatorcontrib>Khan, Tariq Aziz</creatorcontrib><creatorcontrib>Miller-Moslin, Karen</creatorcontrib><creatorcontrib>Wei, Li</creatorcontrib><creatorcontrib>Argiris, Athanassios</creatorcontrib><title>Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>CheckMate 651 (ClinicalTrials.gov identifier: NCT02741570) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil ≤ six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Patients without prior systemic therapy for R/M SCCHN were randomly assigned 1:1 to nivolumab plus ipilimumab or EXTREME. Primary end points were overall survival (OS) in the all randomly assigned and programmed death-ligand 1 combined positive score (CPS) ≥ 20 populations. Secondary end points included OS in the programmed death-ligand 1 CPS ≥ 1 population, and progression-free survival, objective response rate, and duration of response in the all randomly assigned and CPS ≥ 20 populations.
Among 947 patients randomly assigned, 38.3% had CPS ≥ 20. There were no statistically significant differences in OS with nivolumab plus ipilimumab versus EXTREME in the all randomly assigned (median: 13.9
13.5 months; hazard ratio [HR], 0.95; 97.9% CI, 0.80 to 1.13;
= .4951) and CPS ≥ 20 (median: 17.6
14.6 months; HR, 0.78; 97.51% CI, 0.59 to 1.03;
= .0469) populations. In patients with CPS ≥ 1, the median OS was 15.7 versus 13.2 months (HR, 0.82; 95% CI, 0.69 to 0.97). Among patients with CPS ≥ 20, the median progression-free survival was 5.4 months (nivolumab plus ipilimumab) versus 7.0 months (EXTREME), objective response rate was 34.1% versus 36.0%, and median duration of response was 32.6 versus 7.0 months. Grade 3/4 treatment-related adverse events occurred in 28.2% of patients treated with nivolumab plus ipilimumab versus 70.7% treated with EXTREME.
CheckMate 651 did not meet its primary end points of OS in the all randomly assigned or CPS ≥ 20 populations. Nivolumab plus ipilimumab showed a favorable safety profile compared with EXTREME. There continues to be a need for new therapies in patients with R/M SCCHN.</description><subject>Antineoplastic Agents, Immunological - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Cetuximab</subject><subject>Head and Neck Neoplasms - drug therapy</subject><subject>Humans</subject><subject>Ipilimumab - adverse effects</subject><subject>Neoplasm Recurrence, Local - etiology</subject><subject>Nivolumab - adverse effects</subject><subject>ORIGINAL REPORTS</subject><subject>Squamous Cell Carcinoma of Head and Neck - drug therapy</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVkUtv1DAUhS0EokNhxxp5yYJM_UjiCRuEohlaNNOiMqDurBv7pmPIY2o7lfq3-gtxH1TgjX3P_XRs30PIW87mXDB29LU-mwsxZ0xK8YzMeCFUplRRPCczpqTI-EJeHJBXIfxijOcLWbwkB7LMleS5nJHbU3c9dlMPDf3WTYGe7F3n-vv6J_qQlOXF9ny5WdJzvHQ9DhQCXTkfYrZ2A9KtR4hJjrQdfWLM5H2qjjYYIUSIztDvVxP0Y3KqsetoDd64YeyBji2NO6THCJbCYOkpmt8f6TZJKzdAl8zC1MVwx9W71NtARFoW_DV50UIX8M3jfkh-rJbb-jhbn305qT-vM5NXecxKqxS0uS1NC8qiaGxlGKuqdFg0KExppCmwKlRT8FyxheW2YtxyY6pFyVgjD8mnB9_91PRoTfqWh07vvevB3-gRnP6_M7idvhyvNWecF2klh_ePDn68mjBE3btg0hRgwDQQLZTKZa5UyRP64QE1fgzBY_t0D2f6LmedctZC6PucE_7u37c9wX-DlX8AABGlhQ</recordid><startdate>20230420</startdate><enddate>20230420</enddate><creator>Haddad, Robert I</creator><creator>Harrington, Kevin</creator><creator>Tahara, Makoto</creator><creator>Ferris, Robert L</creator><creator>Gillison, Maura</creator><creator>Fayette, Jerome</creator><creator>Daste, Amaury</creator><creator>Koralewski, Piotr</creator><creator>Zurawski, Bogdan</creator><creator>Taberna, Miren</creator><creator>Saba, Nabil F</creator><creator>Mak, Milena</creator><creator>Kawecki, Andrzej</creator><creator>Girotto, Gustavo</creator><creator>Alvarez Avitia, Miguel Angel</creator><creator>Even, Caroline</creator><creator>Toledo, Joaquin Gabriel Reinoso</creator><creator>Guminski, Alexander</creator><creator>Müller-Richter, Urs</creator><creator>Kiyota, Naomi</creator><creator>Roberts, Mustimbo</creator><creator>Khan, Tariq Aziz</creator><creator>Miller-Moslin, Karen</creator><creator>Wei, Li</creator><creator>Argiris, Athanassios</creator><general>Wolters Kluwer Health</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>5PM</scope><orcidid>https://orcid.org/0000-0002-6014-348X</orcidid><orcidid>https://orcid.org/0000-0003-1413-0079</orcidid><orcidid>https://orcid.org/0000-0002-4098-1320</orcidid><orcidid>https://orcid.org/0000-0001-5876-6533</orcidid><orcidid>https://orcid.org/0000-0001-8021-6116</orcidid><orcidid>https://orcid.org/0000-0003-4075-8812</orcidid><orcidid>https://orcid.org/0000-0001-9035-3106</orcidid><orcidid>https://orcid.org/0000-0003-4972-1477</orcidid><orcidid>https://orcid.org/0000-0003-3681-7015</orcidid><orcidid>https://orcid.org/0000-0001-7869-7686</orcidid><orcidid>https://orcid.org/0000-0001-6605-2071</orcidid></search><sort><creationdate>20230420</creationdate><title>Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651</title><author>Haddad, Robert I ; Harrington, Kevin ; Tahara, Makoto ; Ferris, Robert L ; Gillison, Maura ; Fayette, Jerome ; Daste, Amaury ; Koralewski, Piotr ; Zurawski, Bogdan ; Taberna, Miren ; Saba, Nabil F ; Mak, Milena ; Kawecki, Andrzej ; Girotto, Gustavo ; Alvarez Avitia, Miguel Angel ; Even, Caroline ; Toledo, Joaquin Gabriel Reinoso ; Guminski, Alexander ; Müller-Richter, Urs ; Kiyota, Naomi ; Roberts, Mustimbo ; Khan, Tariq Aziz ; Miller-Moslin, Karen ; Wei, Li ; Argiris, Athanassios</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c494t-6d77af4d6cfa7de2bd9c00992bd8be2c6c3c5e957b514708d1d901d1cc98600b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antineoplastic Agents, Immunological - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Carcinoma, Squamous Cell - drug therapy</topic><topic>Cetuximab</topic><topic>Head and Neck Neoplasms - drug therapy</topic><topic>Humans</topic><topic>Ipilimumab - adverse effects</topic><topic>Neoplasm Recurrence, Local - etiology</topic><topic>Nivolumab - adverse effects</topic><topic>ORIGINAL REPORTS</topic><topic>Squamous Cell Carcinoma of Head and Neck - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Haddad, Robert I</creatorcontrib><creatorcontrib>Harrington, Kevin</creatorcontrib><creatorcontrib>Tahara, Makoto</creatorcontrib><creatorcontrib>Ferris, Robert L</creatorcontrib><creatorcontrib>Gillison, Maura</creatorcontrib><creatorcontrib>Fayette, Jerome</creatorcontrib><creatorcontrib>Daste, Amaury</creatorcontrib><creatorcontrib>Koralewski, Piotr</creatorcontrib><creatorcontrib>Zurawski, Bogdan</creatorcontrib><creatorcontrib>Taberna, Miren</creatorcontrib><creatorcontrib>Saba, Nabil F</creatorcontrib><creatorcontrib>Mak, Milena</creatorcontrib><creatorcontrib>Kawecki, Andrzej</creatorcontrib><creatorcontrib>Girotto, Gustavo</creatorcontrib><creatorcontrib>Alvarez Avitia, Miguel Angel</creatorcontrib><creatorcontrib>Even, Caroline</creatorcontrib><creatorcontrib>Toledo, Joaquin Gabriel Reinoso</creatorcontrib><creatorcontrib>Guminski, Alexander</creatorcontrib><creatorcontrib>Müller-Richter, Urs</creatorcontrib><creatorcontrib>Kiyota, Naomi</creatorcontrib><creatorcontrib>Roberts, Mustimbo</creatorcontrib><creatorcontrib>Khan, Tariq Aziz</creatorcontrib><creatorcontrib>Miller-Moslin, Karen</creatorcontrib><creatorcontrib>Wei, Li</creatorcontrib><creatorcontrib>Argiris, Athanassios</creatorcontrib><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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Haddad, Robert I</au><au>Harrington, Kevin</au><au>Tahara, Makoto</au><au>Ferris, Robert L</au><au>Gillison, Maura</au><au>Fayette, Jerome</au><au>Daste, Amaury</au><au>Koralewski, Piotr</au><au>Zurawski, Bogdan</au><au>Taberna, Miren</au><au>Saba, Nabil F</au><au>Mak, Milena</au><au>Kawecki, Andrzej</au><au>Girotto, Gustavo</au><au>Alvarez Avitia, Miguel Angel</au><au>Even, Caroline</au><au>Toledo, Joaquin Gabriel Reinoso</au><au>Guminski, Alexander</au><au>Müller-Richter, Urs</au><au>Kiyota, Naomi</au><au>Roberts, Mustimbo</au><au>Khan, Tariq Aziz</au><au>Miller-Moslin, Karen</au><au>Wei, Li</au><au>Argiris, Athanassios</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>2023-04-20</date><risdate>2023</risdate><volume>41</volume><issue>12</issue><spage>2166</spage><epage>2180</epage><pages>2166-2180</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>CheckMate 651 (ClinicalTrials.gov identifier: NCT02741570) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil ≤ six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Patients without prior systemic therapy for R/M SCCHN were randomly assigned 1:1 to nivolumab plus ipilimumab or EXTREME. Primary end points were overall survival (OS) in the all randomly assigned and programmed death-ligand 1 combined positive score (CPS) ≥ 20 populations. Secondary end points included OS in the programmed death-ligand 1 CPS ≥ 1 population, and progression-free survival, objective response rate, and duration of response in the all randomly assigned and CPS ≥ 20 populations.
Among 947 patients randomly assigned, 38.3% had CPS ≥ 20. There were no statistically significant differences in OS with nivolumab plus ipilimumab versus EXTREME in the all randomly assigned (median: 13.9
13.5 months; hazard ratio [HR], 0.95; 97.9% CI, 0.80 to 1.13;
= .4951) and CPS ≥ 20 (median: 17.6
14.6 months; HR, 0.78; 97.51% CI, 0.59 to 1.03;
= .0469) populations. In patients with CPS ≥ 1, the median OS was 15.7 versus 13.2 months (HR, 0.82; 95% CI, 0.69 to 0.97). Among patients with CPS ≥ 20, the median progression-free survival was 5.4 months (nivolumab plus ipilimumab) versus 7.0 months (EXTREME), objective response rate was 34.1% versus 36.0%, and median duration of response was 32.6 versus 7.0 months. Grade 3/4 treatment-related adverse events occurred in 28.2% of patients treated with nivolumab plus ipilimumab versus 70.7% treated with EXTREME.
CheckMate 651 did not meet its primary end points of OS in the all randomly assigned or CPS ≥ 20 populations. Nivolumab plus ipilimumab showed a favorable safety profile compared with EXTREME. There continues to be a need for new therapies in patients with R/M SCCHN.</abstract><cop>United States</cop><pub>Wolters Kluwer Health</pub><pmid>36473143</pmid><doi>10.1200/JCO.22.00332</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0002-6014-348X</orcidid><orcidid>https://orcid.org/0000-0003-1413-0079</orcidid><orcidid>https://orcid.org/0000-0002-4098-1320</orcidid><orcidid>https://orcid.org/0000-0001-5876-6533</orcidid><orcidid>https://orcid.org/0000-0001-8021-6116</orcidid><orcidid>https://orcid.org/0000-0003-4075-8812</orcidid><orcidid>https://orcid.org/0000-0001-9035-3106</orcidid><orcidid>https://orcid.org/0000-0003-4972-1477</orcidid><orcidid>https://orcid.org/0000-0003-3681-7015</orcidid><orcidid>https://orcid.org/0000-0001-7869-7686</orcidid><orcidid>https://orcid.org/0000-0001-6605-2071</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0732-183X |
| ispartof | Journal of clinical oncology, 2023-04, Vol.41 (12), p.2166-2180 |
| issn | 0732-183X 1527-7755 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10115555 |
| source | MEDLINE; American Society of Clinical Oncology; Alma/SFX Local Collection; EZB Electronic Journals Library |
| subjects | Antineoplastic Agents, Immunological - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Carcinoma, Squamous Cell - drug therapy Cetuximab Head and Neck Neoplasms - drug therapy Humans Ipilimumab - adverse effects Neoplasm Recurrence, Local - etiology Nivolumab - adverse effects ORIGINAL REPORTS Squamous Cell Carcinoma of Head and Neck - drug therapy |
| title | Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-01T10%3A57%3A04IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Nivolumab%20Plus%20Ipilimumab%20Versus%20EXTREME%20Regimen%20as%20First-Line%20Treatment%20for%20Recurrent/Metastatic%20Squamous%20Cell%20Carcinoma%20of%20the%20Head%20and%20Neck:%20The%20Final%20Results%20of%20CheckMate%20651&rft.jtitle=Journal%20of%20clinical%20oncology&rft.au=Haddad,%20Robert%20I&rft.date=2023-04-20&rft.volume=41&rft.issue=12&rft.spage=2166&rft.epage=2180&rft.pages=2166-2180&rft.issn=0732-183X&rft.eissn=1527-7755&rft_id=info:doi/10.1200/JCO.22.00332&rft_dat=%3Cproquest_pubme%3E2774347761%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2774347761&rft_id=info:pmid/36473143&rfr_iscdi=true |