A Phase II Feasibility Study Combining Pembrolizumab and Metformin in Patients with Metastatic Head and Neck Cancer.
Clin Cancer ResSep 15, 2026
Olga Zamulko, Sam Nusbaum, Andrew Osterburg et al.
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In 30 seconds
This Phase II randomized controlled trial evaluated the combination of metformin and pembrolizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Among 18 evaluable patients, the overall response rate (ORR) was 50% (95% CI 29-71), indicating promising activity of the combination therapy.
Key findings
- The overall response rate (ORR) was 50% with four complete and five partial responses.
- Combination therapy was well tolerated, with no unexpected adverse events reported.
- Five grade 3 adverse events occurred, including nausea, diarrhea, fatigue, and weight loss.
- Metformin increased peripheral NK-cell maturation and cytotoxic ability.
Why it matters
The low response rates in R/M HNSCC highlight the need for effective treatment strategies. This study suggests that combining metformin with pembrolizumab may enhance therapeutic outcomes, warranting further exploration.