What is it about?
This multicenter phase II study investigated the efficacy and safety of nivolumab monotherapy in patients with platinum-refractory recurrent or metastatic salivary gland cancer (RM-SGC). Salivary gland cancer is a rare and heterogeneous disease, and the clinical role of immune checkpoint inhibitors in this setting has not been well established. In this open-label, single-arm trial conducted at nine centers in Japan, patients received nivolumab 240 mg intravenously every two weeks. The primary endpoint was objective response rate (ORR), and secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Multiple histological subtypes were included, such as salivary duct carcinoma (SDC), adenoid cystic carcinoma (AdCC), and adenocarcinoma not otherwise specified (ANOS). A total of 24 patients were enrolled. The study did not meet its primary endpoint, with an overall ORR of 8.3%. However, treatment response differed by histological subtype. Partial responses were observed only in patients with SDC, while no objective responses were seen in AdCC or other subtypes. Although most patients experienced early disease progression, durable stable disease was observed in a small number of patients, mainly those with ANOS. Median PFS was 3.0 months and median OS was 25.0 months. Nivolumab was generally well tolerated, and no new safety signals were identified. This study provides prospective evidence that nivolumab has limited overall activity in RM-SGC, while highlighting clear differences in efficacy among histological subtypes.
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Why is it important?
Evidence to guide systemic therapy for platinum-refractory salivary gland cancer is extremely limited. This study is important because it provides prospective, multicenter data on the use of immune checkpoint inhibition in this rare disease. The results clarify that nivolumab monotherapy offers only modest benefit overall, but may be selectively useful in salivary duct carcinoma. At the same time, the lack of efficacy in AdCC and other subtypes underscores the need for alternative therapeutic strategies. These findings help refine patient selection and set realistic expectations for immunotherapy in clinical practice.
Perspectives
The results emphasize the importance of histology-driven treatment strategies in salivary gland cancer. For SDC, combination approaches involving immune checkpoint inhibitors may improve outcomes. In contrast, for AdCC and other subtypes, novel strategies beyond immunotherapy are required. Future studies should focus on understanding the tumor immune microenvironment and identifying biomarkers that can guide treatment selection. International collaboration and translational research will be essential to develop more effective therapies for this rare and heterogeneous group of cancers.
Naomi Kiyota
Kobe University Hospital
Read the Original
This page is a summary of: A phase II trial of nivolumab for patients with platinum-refractory recurrent or metastatic salivary gland cancer, Japanese Journal of Clinical Oncology, December 2025, Oxford University Press (OUP),
DOI: 10.1093/jjco/hyaf192.
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