Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial
[Background] Herein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS).
| Autores: | , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Consejo Superior de Investigaciones Científicas (CSIC) |
| Repositorio: | DIGITAL.CSIC. Repositorio Institucional del CSIC |
| OAI Identifier: | oai:digital.csic.es:10261/390726 |
| Acceso en línea: | http://hdl.handle.net/10261/390726 https://api.elsevier.com/content/abstract/scopus_id/85208970345 |
| Access Level: | acceso abierto |
| Palabra clave: | Ewing sarcoma PD‐L1 inhibitor Anti‐angiogeninic Bone Dedifferentiated chondrosarcoma Immunotherapya Nivolumab Osteosarcoma Sarcoma Sunitinib |
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Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trialPalmerini, EmanuelaPousa, A. L.Grignani, GiovanniRedondo, AndrésHindi, NadiaProvenzano, SalvatoreSebio, AnaLópez-Martín, José A.Valverde, ClaudiaMartínez-Trufero, JavierCea Gutiérrez, AntonioÁlava, Enrique deAparisi Gómez, María PilarD'Ambrosio, LorenzoCollini, PaolaBazzocchi, AlbertoMoura, David S.Ibrahim, ToniStacchiotti, SilviaBroto, Javier MartinEwing sarcomaPD‐L1 inhibitorAnti‐angiogeninicBoneDedifferentiated chondrosarcomaImmunotherapyaNivolumabOsteosarcomaPD‐L1 inhibitorSarcomaSunitinib[Background] Herein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS).[Methods] Progressing patients with a diagnosis of BS were eligible. Treatment was comprised of sunitinib (37.5 mg/day on days 1–14, 25 mg/day afterword) plus nivolumab (3 mg/kg every 2 weeks). Primary end point was progression-free survival rate (PFSR) at 6 months based on central radiology review. Secondary end points were overall survival (OS), overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and safety.[Results] A total of 46 patients were screened, 40 patients entered the study, and 38 underwent central radiological review and were evaluable for primary end point. Median age was 47 years (range, 21–74). Histologies include 17 (43%) osteosarcoma, 14 chondrosarcoma (35%, 10 conventional, four dedifferentiated [DDCS]), eight (20%) Ewing sarcoma, and one (2%) undifferentiated pleomorphic sarcoma. The PFSR at 6 months was 42% (95% confidence interval [CI], 27–58). With a median follow-up of 39.8 months (95% CI, 37.9–41.7), the median PFS and OS were 3.8 months (95% CI, 2.7–4.8) and 11.9 months (95% CI, 5.6–18.2). ORR by RECIST was 5%, with two of 38 partial responses (one of four DDCS and one of 17 osteosarcoma), 19 of 38 (50%) stable disease, and 17 of 38 (45%) progressions. Grade ≥3 adverse events were neutropenia (six of 40, 15%), anemia (5/40, hypertension (6/40, 15%), 12.5%), ALT/AST elevation (5/40, 12.5%), and pneumonitis (1/40, 2.5%). Seventeen percent of patients discontinued treatment due to toxicity, including a treatment-related grade 5 pneumonitis.[Conclusion] The trial met its primary end point in the BS cohort with >15% of patients progression-free at 6 months. However, the toxicity profile of this regimen was relevant.Bristol-Myers Squibb (BMS) and Pfizer provided drug supply and partial funding for logistics. This work was supported by the CARISBO Foundation Call for Translational and Clinical Medical Research. Open access funding provided by BIBLIOSAN.Peer reviewedWiley-VCHBristol-Myers SquibbPfizerFondazione CarisboBibliosanPalmerini, Emanuela [0000-0003-3406-6705]Martínez-Trufero, Javier [0000-0002-0997-2573]Stacchiotti, Silvia [0000-0002-1742-8666]Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]202520252025info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501application/pdfhttp://hdl.handle.net/10261/390726https://api.elsevier.com/content/abstract/scopus_id/85208970345reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)InglésThe underlying dataset has been published as supplementary material of the article in the publisher platform at DOI http://dx.doi.org/10.1002/cncr.35628http://dx.doi.org/10.1002/cncr.35628Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/3907262026-05-22T06:33:51Z |
| dc.title.none.fl_str_mv |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| title |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| spellingShingle |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial Palmerini, Emanuela Ewing sarcoma PD‐L1 inhibitor Anti‐angiogeninic Bone Dedifferentiated chondrosarcoma Immunotherapya Nivolumab Osteosarcoma PD‐L1 inhibitor Sarcoma Sunitinib |
| title_short |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| title_full |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| title_fullStr |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| title_full_unstemmed |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| title_sort |
Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial |
| dc.creator.none.fl_str_mv |
Palmerini, Emanuela Pousa, A. L. Grignani, Giovanni Redondo, Andrés Hindi, Nadia Provenzano, Salvatore Sebio, Ana López-Martín, José A. Valverde, Claudia Martínez-Trufero, Javier Cea Gutiérrez, Antonio Álava, Enrique de Aparisi Gómez, María Pilar D'Ambrosio, Lorenzo Collini, Paola Bazzocchi, Alberto Moura, David S. Ibrahim, Toni Stacchiotti, Silvia Broto, Javier Martin |
| author |
Palmerini, Emanuela |
| author_facet |
Palmerini, Emanuela Pousa, A. L. Grignani, Giovanni Redondo, Andrés Hindi, Nadia Provenzano, Salvatore Sebio, Ana López-Martín, José A. Valverde, Claudia Martínez-Trufero, Javier Cea Gutiérrez, Antonio Álava, Enrique de Aparisi Gómez, María Pilar D'Ambrosio, Lorenzo Collini, Paola Bazzocchi, Alberto Moura, David S. Ibrahim, Toni Stacchiotti, Silvia Broto, Javier Martin |
| author_role |
author |
| author2 |
Pousa, A. L. Grignani, Giovanni Redondo, Andrés Hindi, Nadia Provenzano, Salvatore Sebio, Ana López-Martín, José A. Valverde, Claudia Martínez-Trufero, Javier Cea Gutiérrez, Antonio Álava, Enrique de Aparisi Gómez, María Pilar D'Ambrosio, Lorenzo Collini, Paola Bazzocchi, Alberto Moura, David S. Ibrahim, Toni Stacchiotti, Silvia Broto, Javier Martin |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Bristol-Myers Squibb Pfizer Fondazione Carisbo Bibliosan Palmerini, Emanuela [0000-0003-3406-6705] Martínez-Trufero, Javier [0000-0002-0997-2573] Stacchiotti, Silvia [0000-0002-1742-8666] Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72] |
| dc.subject.none.fl_str_mv |
Ewing sarcoma PD‐L1 inhibitor Anti‐angiogeninic Bone Dedifferentiated chondrosarcoma Immunotherapya Nivolumab Osteosarcoma PD‐L1 inhibitor Sarcoma Sunitinib |
| topic |
Ewing sarcoma PD‐L1 inhibitor Anti‐angiogeninic Bone Dedifferentiated chondrosarcoma Immunotherapya Nivolumab Osteosarcoma PD‐L1 inhibitor Sarcoma Sunitinib |
| description |
[Background] Herein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS). |
| publishDate |
2025 |
| dc.date.none.fl_str_mv |
2025 2025 2025 |
| dc.type.none.fl_str_mv |
info:eu-repo/semantics/article http://purl.org/coar/resource_type/c_6501 |
| format |
article |
| dc.identifier.none.fl_str_mv |
http://hdl.handle.net/10261/390726 https://api.elsevier.com/content/abstract/scopus_id/85208970345 |
| url |
http://hdl.handle.net/10261/390726 https://api.elsevier.com/content/abstract/scopus_id/85208970345 |
| dc.language.none.fl_str_mv |
Inglés |
| language_invalid_str_mv |
Inglés |
| dc.relation.none.fl_str_mv |
The underlying dataset has been published as supplementary material of the article in the publisher platform at DOI http://dx.doi.org/10.1002/cncr.35628 http://dx.doi.org/10.1002/cncr.35628 Sí |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
| dc.publisher.none.fl_str_mv |
Wiley-VCH |
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Wiley-VCH |
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reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC instname:Consejo Superior de Investigaciones Científicas (CSIC) |
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Consejo Superior de Investigaciones Científicas (CSIC) |
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DIGITAL.CSIC. Repositorio Institucional del CSIC |
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DIGITAL.CSIC. Repositorio Institucional del CSIC |
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