Therapy Areas: Vaccines
Immunicum reports positive phase II MERECA topline results from MERECA clinical trial
30 August 2019 -

Immunicum AB (STO:IMMU), a biopharmaceutical company developing therapeutic cancer vaccines, reported on Thursday topline results from the global, exploratory, phase II Metastatic Renal Cell Carcinoma (MERECA) clinical trial.

This study's objective was to evaluate the therapeutic impact of combining ilixadencel with Sutent (sunitinib).

Reportedly, the most important outcome was achieving five complete responses, defined as eradication of the cancerous tumour and no further evidence of disease, without ilixadencel adding toxicity.

Due to a high rate of overall survival in both study arms, median overall survival has not yet been reached. According to the company, these results strongly support the continued clinical development of ilixadencel in kidney cancer as well as other solid tumour indications.

MERECA is an exploratory, international, randomised, controlled and open-label phase II clinical trial in which a total of 88 newly diagnosed, intermediate and poor-prognosis metastatic renal cancer patients were enrolled. The primary objectives of the study were to evaluate median overall survival (OS) and 18-month survival rates. Based on a 2-to-1 randomisation, patients received either two intratumoral doses of ilixadencel before nephrectomy (surgical removal of the tumour-affected kidney) and subsequent treatment with sunitinib, or sunitinib therapy alone post-nephrectomy. Secondary objectives included evaluation of safety and tolerability, tumour response and immunological profiling including T cell infiltration.

The overall safety and tolerability results were similar in the two treatment groups and in line with previous positive safety data for ilixadencel in clinical trials, the company added.

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