Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
Elraglusib, a Glycogen Synthase Kinase 3β Inhibitor, plus Chemotherapy with or without Immunotherapy in Patients with Recurrent, Metastatic Salivary Gland Carcinoma.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
purposeGlycogen synthase kinase 3β (GSK-3β) is a known therapeutic target in cancer. Aberrant nuclear GSK-3β (nGSK-3β) expression has been shown in some salivary gland cancers. Elraglusib is a small-molecule GSK-3β inhibitor with immunomodulatory potential. We hypothesized that elraglusib plus platinum-based chemotherapy and immunotherapy priming would be a novel treatment approach for salivary gland cancer. PATIENTS AND
methodsThis phase II, open-label trial enrolled patients with recurrent or metastatic salivary gland cancer [adenoid cystic carcinoma (ACC) vs. other subtypes] with disease progression in the preceding year. Cohort 1 received elraglusib (15 mg/kg i.v. on days 1 and 4) plus carboplatin (AUC = 5) or cisplatin (75 mg/m2) every 21 days. Cohort 2 received two cycles of pembrolizumab (200 mg i.v.) every 21 days prior to the same regimen. The primary endpoint included best overall response rate (ORR) by RECIST v1.1 (>5/32 in response to detect 25% ORR).
resultsThirty-two patients were enrolled, including 15 (47%) with ACC and 17 (53%) with non-ACC. The best ORR was 9.4% [3/32; 95% confidence interval (CI), 2-25; three partial responses, all non-ACC]. Nineteen (59%) patients achieved stable disease. The median duration of response was 6.9 months. Common treatment-related adverse events were anemia (22, 69%), nausea (16, 50%), and neutropenia (14, 44%). At the median follow-up of 18.3 months, the median progression-free survival was 6.4 months (95% CI, 2.3-8.8), and the median overall survival was 18.6 months (95% CI, 9.7-29.4) overall. The median nGSK-3β expression was 50% versus 2% for responders versus nonresponders.
conclusionsThe trial did not meet its primary endpoint, although 18% of patients with non-ACC treated with immune priming followed by cisplatin plus elraglusib achieved a response. Higher nGSK-3β expression was observed in tumor samples obtained from responders.
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