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Data from a recent phase I study of seleno-L-methionine in combination with axitinib (Inlyta) as treatment for patients with previously treated or relapsed clear cell renal cell carcinoma (ccRCC) were presented at the American Urological Association (AUA) Virtual Experience meeting over the weekend.
There were 15 patients in the study with ccRCC whose disease had progressed on one or more prior lines of treatment. Responses were seen in all patients who received seleno-L-methionine in combination with axitinib. Overall responses were seen in 53% of patients (n = 8). Complete responses were observed in 2 patients and were still ongoing at 31 and 29 months, respectively. Six patients had partial responses, with a disease control rate of about 73%. Some responses lasted for more than 3 years.
There were no dose-limiting toxicities in the study and most adverse events were mild or moderate in severity. The most common adverse events were fatigue, diarrhoea, hypertension, nausea, loss of appetite, cough, protein in the urine, and weight loss. The most common severe or life-threatening/disabling adverse event was hypertension. These adverse events are consistent with the known side effect profile for axitinib.