| Title: |
Nivolumab and sunitinib in patients with advanced bone sarcomas : A multicenter, single-arm, phase 2 trial |
| Authors: |
Palmerini, Emanuela; López Pousa, Antonio; Grignani, Giovanni; Redondo Sánchez, Andrés; Hindi, Nadia; Provenzano, S.; Sebio, Ana; Lopez Martin, J.A.; Valverde, Claudia; Martínez Trufero, Javier; Gutiérrez, Antonio; De Álava, Enrique; Aparisi Gomez, M.P.; D'Ambrosio, L.; Collini, Paola; Bazzocchi, A.; Moura, D.S.; Ibrahim, T.; Stacchiotti, Silvia; Broto, J.M.; Universitat Autònoma de Barcelona |
| Publication Year: |
2025 |
| Collection: |
Universitat Autònoma de Barcelona: Dipòsit Digital de Documents de la UAB |
| Subject Terms: |
Ewing sarcoma; PD-L1 inhibitor; Anti-angiogeninic; Bone; Dedifferentiated chondrosarcoma; Immunotherapy; Nivolumab; Osteosarcoma; 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). 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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
10970142 |
| Relation: |
Cancer; Vol. 131 Núm. 1 (january 2025), p. e35628; https://ddd.uab.cat/record/310163; urn:10.1002/cncr.35628; urn:oai:ddd.uab.cat:310163; urn:scopus_id:85208970345; urn:articleid:10970142v131n1ae35628; urn:pmid:39540661; urn:pmcid:PMC11694334; urn:oai:pubmedcentral.nih.gov:11694334 |
| Availability: |
https://ddd.uab.cat/record/310163 |
| Rights: |
open access ; Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. ; https://creativecommons.org/licenses/by-nc/4.0/ |
| Accession Number: |
edsbas.F819BFE7 |
| Database: |
BASE |