The company has announced positive Phase II MERECA results, including complete tumor responses in metastatic renal cell carcinoma patients.
The study’s objective was to evaluate the therapeutic impact of combining ilixadencel with Sutent (sunitinib). The most important outcome was achieving five complete responses, defined as eradication of the cancerous tumor 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. The results strongly support the continued clinical development of ilixadencel in kidney cancer as well as other solid tumor indications.
A major step forward
“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,” commented Dr. Magnus Lindskog, Associate Professor at Uppsala University Hospital and MERECA investigator. “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.”
“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,” said Carlos de Sousa, CEO of Immunicum. “We are eager to conduct the full analysis of the data and use that to refine and accelerate ilixadencel’s clinical development.”
MERECA is an exploratory, international, randomized, 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 randomization, patients received either two intratumoral doses of ilixadencel before nephrectomy (surgical removal of the tumor-affected kidney) and subsequent treatment with sunitinib or sunitinib therapy alone post-nephrectomy. Secondary objectives included evaluation of safety and tolerability, tumor response and immunological profiling including T cell infiltration.
Of the 88 patients enrolled, 70 patients were evaluable for overall response as per RECIST v1.1 using a central blinded review (45 patients in the ilixadencel treatment group, 25 patients in the control group). Complete tumor response was seen in 5 out of 45 patients who received ilixadencel (11%) and 1 out of 25 patients in the control group (4%). Median overall survival has not yet been reached in either group. The 18-month survival rates were similar being 63% in the ilixadencel treatment group and 66% in the control group and additional survival data will be collected from these patients. Median Progression Free Survival (PFS) and Time To Progression (TTP) were similar in the two treatment arms. The immunological profiling including T cell infiltration data need further analysis.
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.
Ilixadencel together with sunitinib produced a surprisingly high number of complete responses in this patient population without added toxicity from ilixadencel. The available topline data from the MERECA study provides a solid foundation for further clinical development of ilixadencel as an effective immune primer in solid tumors. Moving forward, the data gathered from this study will be further examined and published in a peer-reviewed journal or presented at a scientific conference.
“Immuno-oncology has changed cancer therapy outcomes by making complete responses more possible and the data seen in the MERECA trial support ilixadencel’s potential for increasing the number of patients who can hope for such an outcome,” added Peter Suenaert, MD, PhD, Chief Medical Officer at Immunicum.
Photo of Carlos de Sousa