Immunicum has reported positive results from Phase II Metastatic Renal Cell Carcinoma (MERECA) trial, which evaluated the therapeutic impact of combining ilixadencel with sutent (sunitinib).
The combination of ilixadencel and sutent achieved complete tumour responses in five out of 45 evaluable metastatic kidney cancer patients (11%) compared to one out of 25 in the sutent monotherapy control arm (4%).
Immunicum said that the trial did not achieve the median overall survival rate due to extended patient survival of above 60% in both the treatment and control study arms at 18 months.
The exploratory, international, randomised, controlled and open-label Phase II trial MERECA enrolled a total of 88 newly diagnosed, intermediate and poor-prognosis metastatic renal cancer patients.
The trial’s primary objectives were to evaluate median overall survival (OS) and 18-month survival rates.
Evaluation of safety and tolerability, tumour response and immunological profiling, including T-cell infiltration were the secondary objectives of the trial.
Based on these trial results, the company plans to continue further studies on the development of ilixadencel in kidney cancer and other solid tumour indications.
Immunicum CEO Carlos de Sousa said: “Our main objective for MERECA was to explore the therapeutic benefit of ilixadencel in combination with a standard treatment regimen.
“The surprising number of complete responses in advanced-stage cancer patients is particularly encouraging and highly supportive of our vision for ilixadencel as a backbone therapy in modern cancer treatment regimens.”
According to the company, the overall safety and tolerability results were similar in both the treatment groups and are in line with previous clinical trials data for ilixadencel.
MERECA investigator Dr Magnus Lindskog said: “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.”
In August 2017, the company started patient enrolment for Phase II MERECA clinical trial and ended the enrolment last January.