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Cited by 159Sarcoma Diagnosis and TreatmentCancer Immunotherapy and BiomarkersSarcoidosis and Beryllium Toxicity Research

Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial.

Somaiah, Neeta, Conley, Anthony P, Parra, Edwin Roger, Lin, Heather, Amini, Behrang, Solis Soto, Luisa, Salazar, Ruth, Barreto, Carmelia +24 more·2022·The Lancet Oncology
DOI 10.1016/s1470-2045(22)00392-8
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Abstract

Background Few standard treatment options are available for patients with metastatic sarcomas. We did this trial to evaluate the efficacy, safety, and changes in the tumour microenvironment for durvalumab, an anti-PD-L1 drug, and tremelimumab, an anti-CTLA-4 drug, across multiple sarcoma subtypes.Methods In this single-centre phase 2 trial, done at The University of Texas MD Anderson Cancer Center (Houston, TX USA), patients aged 18 years or older with advanced or metastatic sarcoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 who had received at least one previous line of systemic therapy were enrolled in disease subtype-specific groups (liposarcoma, leiomyosarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, synovial sarcoma, osteosarcoma, alveolar soft-part sarcoma, chordoma, and other sarcomas). Patients received 1500 mg intravenous durvalumab and 75 mg intravenous tremelimumab for four cycles, followed by durvalumab alone every 4 weeks for up to 12 months. The primary endpoint was progression-free survival at 12 weeks in the intention-to-treat population (all patients who received at least one dose of treatment). Safety was also analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02815995, and is completed.Findings Between Aug 17, 2016, and April 9, 2018, 62 patients were enrolled, of whom 57 (92%) received treatment and were included in the intention-to-treat population. With a median follow-up of 37·2 months (IQR 1·8-10·1), progression-free survival at 12 weeks was 49% (95% CI 36-61). 21 grade 3-4 treatment-related adverse events were reported, the most common of which were increased lipase (four [7%] of 57 patients), colitis (three [5%] patients), and pneumonitis (three [5%] patients). Nine (16%) patients had a treatment related serious adverse event. One patient had grade 5 pneumonitis and colitis.Interpretation The combination of durvalumab and tremelimumab is an active treatment regimen for advanced or metastatic sarcoma and merits evaluation in specific subsets in future trials.Funding AstraZeneca.

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Crossref · 10.1016/s1470-2045(22)00392-8

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  • In a study of adult patients with relapsed sarcoma receiving the same durvalumab and tremelimumab regimen, a single partial response was reported and three patients experienced stable disease within the chordoma cohort (n=5) using irRC; no objective responses were reported within the osteosarcoma cohort.

    “Specifically, in a study of adult patients (18 years or older) with relapsed sarcoma receiving the same durvalumab and tremelimumab regimen used in this study, a single partial response was reported and three patients experienced stable disease within the chordoma cohort (n= 5) using immune-related Response Criteria (irRC); however, no objective responses were reported within the osteosarcoma”

    From Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors (2026) · cites this paper as [24]

  • The PFS at 12 weeks was 49% in patients receiving durvalumab and tremelimumab.

    “The PFS at 12 weeks was 49%.”

    From Advances on immunotherapy for osteosarcoma (2024) · cites this paper as [155]

  • Grade 3-4 treatment-related adverse events were reported in 21 patients receiving durvalumab and tremelimumab.

    “Grade 3–4 treatment-related adverse events were reported in 21 patients [155].”

    From Advances on immunotherapy for osteosarcoma (2024) · cites this paper as [155]

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Authors
Somaiah, N., Conley, A. P., Parra, E. R., Lin, H., Amini, B., Solis Soto, L., Salazar, R., Barreto, C., Chen, H., Gite, S., Haymaker, C., Nassif, E. F., Bernatchez, C., Mitra, A., Livingston, J. A., Ravi, V., Araujo, D. M., Benjamin, R., Patel, S., Zarzour, M. A., Sabir, S., Lazar, A. J., Wang, W.-L., Daw, N. C., Zhou, X., Roland, C. L., Cooper, Z. A., Rodriguez-Canales, J., Futreal, A., Soria, J.-C., Wistuba, I. I., & Hwu, P.
Affiliations
  • The University of Texas MD Anderson Cancer Center (US)
  • Scripps Mercy Hospital (US)
  • AstraZeneca (United States) (US)
  • Moffitt Cancer Center (US)
Corresponding author
Somaiah, Neeta
ORCID
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2022-09
Volume
23
Issue
9
Pages
1156-1166
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(22)00392-8
OpenAlex
W4293860952
Cited by
159
References
29
Citations by year
2026: 29 · 2025: 40 · 2024: 46 · 2023: 36 · 2022: 8
FWCI
20.95
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Oncology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Sarcoma Diagnosis and Treatment
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Physiology › Sarcoidosis and Beryllium Toxicity Research
Keywords
durvalumab, tremelimumab, metastatic sarcoma, soft tissue sarcoma, bone sarcoma, PD-L1 blockade, CTLA-4 blockade, immune checkpoint inhibitors, combination immunotherapy, tumor microenvironment, progression-free survival, liposarcoma, osteosarcoma, chordoma, alveolar soft part sarcoma, treatment-related adverse events
MeSH terms
Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Bone Neoplasms, Colitis, Humans, Pneumonia, Osteosarcoma, Soft Tissue Neoplasms, Sarcoma, Alveolar Soft Part, Tumor Microenvironment, Antibodies, Monoclonal, Humanized

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