A combination therapy of ilixadencel plus sunitinib (Sutent) achieved complete tumor responses in patients with metastatic renal cell carcinoma (RCC), according to new data from a phase 2 clinical study.
Approximately 273,000 new cases of RCC are diagnosed worldwide each year. There is a need for alternative treatment options for these patients, as many of the available targeted therapies offer only a short duration of effect with limited survival gain.
Ilixadencel is an off-the-shelf cancer immune primer developed for the treatment of solid tumors. The MERECA clinical trial evaluated the therapeutic impact of combining ilixadencel with sunitinib in advanced kidney cancer.
For the study, 88 newly-diagnosed, intermediate- and poor-prognosis patients with metastatic RCC were enrolled. Patients received either 2 intratumoral doses of ilixadencel before nephrectomy and subsequent treatment with sunitinib or sunitinib monotherapy post-nephrectomy.
According to the study, a total of 70 patients enrolled in the study were evaluable for overall response. The data demonstrated a complete tumor response in 5 of 45 patients who received ilixadencel (11%) and 1 of 25 patients in the control group (4%). Complete responses were defined as eradication of the cancerous tumor and no further evidence of disease, without ilixadencel adding toxicity. Because of extended patient survival above 60% in both study arms at 18 months, median overall survival has not yet been reached.
Overall, the safety and tolerability results were similar in the 2 treatment groups and in line with previous positive safety data for ilixadencel in clinical trials.
“As a clinical oncologist specialized in treating kidney cancer patients, the prospect of an immune primer that can support the achievement of complete responses in advanced-stage patients with a positive tolerability and safety profile is extremely exciting, especially in an indication in which complete responses are rare,” study investigator Magnus Lindskog, PhD, associate professor at Uppsala University Hospital, said in a statement. “If this response rate can be confirmed in a larger pivotal trial, it would represent a major step forward for the treatment of kidney cancer patients.”
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