Immunicum has announced that in a trial, ilixadencel in combination with Pfizer’s Sutent (sunitinib) achieved complete tumour responses in five out of 45 metastatic kidney cancer patients (11%) in contrast to one out of 25 in the sunitinib monotherapy control arm (4%).
The company said that the number of complete responses and favourable safety profile firmly validate the continued clinical development of ilixadencel as an immune primer in solid tumours.
The overall safety and tolerability results of the global, exploratory, Phase II Metastatic Renal Cell Carcinoma (MERECA) trial were also similar in the two treatment groups and in line with previous positive safety data for ilixadencel in clinical trials.
“As a clinical oncologist specialised 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,” commented Dr. Magnus Lindskog, associate professor at Uppsala University Hospital and MERECA investigator.
He continued to say, “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.”
The most important outcome of the trial was “achieving five complete responses, defined as eradication of the cancerous tumour and no further evidence of disease, without ilixadencel adding toxicity.”
The company added that due to a high rate of overall survival in both study arms, median overall survival has not yet been reached.