Setanaxib-pembrolizumab combination extends survival in advanced head and neck cancer
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The addition of setanaxib to pembrolizumab in adults with squamous cell carcinoma of the head and neck conferred significant improvement in both PFS and OS, according to a topline data release from the agent’s manufacturer.
Researchers conducted a randomized phase 2 trial to assess the efficacy of 800 mg setanaxib (Calliditas Therapeutics) — a NADPH oxidase (NOX) enzyme inhibitor — given twice daily in combination with 200 mg pembrolizumab (Keytruda, Merck), a PD-1 inhibitor, administered intravenously every 3 weeks. Study participants eligible for data analysis (n = 55) had to complete 15 weeks of treatment and be diagnosed with recurrent or metastatic squamous cell carcinoma of the head and neck and moderate or high cancer-associated fibroblast (CAF)-density tumors.
Patients treated with the combination regimen showed a statistically significant improvement in median PFS (5 months vs. 2.9 months; HR = 0.58) and OS (OS rate at 6 months, 92% vs. 68%; OS rate at 9 months, 88% vs. 58%; HR = 0.45) compared with patients treated with pembrolizumab plus placebo.
Study results also indicated an improvement in disease-control rate among patients treated with the investigative combination, with 70% of patients in the setanaxib cohort showing a best response of at least stable disease compared with 52% in the placebo arm.
Investigators reported no significant difference in the study’s primary endpoint of best percentage change from baseline in tumor size; however, transcriptomic analysis of tumor biopsy samples showed a statistically significant increase in CD8-positive T cells in tumor tissue from patients in the setanaxib cohort compared with those who received placebo.
The combination regimen resulted in no new safety signals during the study period, according to the release.
“It is very encouraging to see statistical significance on important clinical outcomes in this relatively small study, which provides an excellent basis for advancing setanaxib in this hard-to-treat population,” Kevin Harrington, MD, PhD, professor in biological cancer therapies at The Institute of Cancer Research (ICR) London, consultant clinical oncologist at The Royal Marsden NHS Foundation and investigator on the trial, said in the release.
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