Oral Dis. 2026 Mar 9. doi: 10.1111/odi.70259. Online ahead of print.
ABSTRACT
PURPOSE: This study aimed to investigate the real-world efficacy of combining Pembrolizumab with Nimotuzumab in patients with Recurrent/Unresectable/Metastatic HNSCC and to analyze the impact of p16 expression on treatment outcomes.
METHODS: The study included 86 patients: 41 received Pembrolizumab monotherapy, and 45 received Pembrolizumab plus Nimotuzumab. Patients were divided into four groups based on treatment and p16 status, analyzing OS, PFS, and ORR.
RESULTS: With a median follow-up of 30.2 months, the combination therapy showed a significantly higher 6-month ORR, longer 1-year PFS and OS compared to monotherapy. Additionally, the combination therapy group notably improved 6-month ORR, 1-year PFS rate, and 1-year OS rate in p16-negative patients when compared to monotherapy. However, there was no significant improvement in ORR, PFS, or OS in p16-positive patients. Adverse events occurred in 61 patients (70.93%), with incidences of 68.29% in the monotherapy and 73.33% in the combination group, showing no statistically significant difference (p > 0.05).
CONCLUSION: The combination of Pembrolizumab and Nimotuzumab demonstrates a notable enhancement in ORR and OS, maintaining a dependable safety profile. Differential p16 expression in HNSCC patients may influence the efficacy of immune-combined targeted therapy, highlighting the importance of considering p16 in the formulation of therapeutic strategies.
PMID:41802984 | DOI:10.1111/odi.70259
