Ilixadencel-Sutent Combo Shows Efficacy in Advanced Kidney Cancer, Phase 2 Trial Reports

A combination of ilixadencel plus Sutent (sunitinib) is showing promising efficacy in patients with kidney cancer that has spread to other organs, according to topline data from a Phase 2 trial.

Ilixadencel, Immunicum‘s lead candidate for the treatment of different types of solid tumors, is a cancer vaccine based on the use of dendritic cells — cells that “show” T-cells, a type of white blood cell that fights cancer, their targets. These dendritic cells are collected from healthy donors.

Once isolated, these cells undergo a procedure to become activated and produce substances that trigger a strong immune response. They are then injected directly into the tumor to trigger an inflammatory response, which in turn will promote the recruitment of T-cells that start attacking cancer cells.

The effects of adding ilixadencel to Sutent, a cancer therapy marketed by Pfizer and approved to treat advanced and recurrent kidney cancer, are currently being assessed in the global, open-label and controlled MERECA Phase 2 trial (NCT02432846).

The study enrolled a total of 88 newly diagnosed patients with metastatic kidney cancer who had an intermediate or poor  prognosis.

Study participants were randomly assigned to two different treatment groups: those who were vaccinated with ilixadencel before undergoing nephrectomy (surgery to remove the kidney) and treated with Sutent after surgery; and those who were only treated with Sutent after surgery (control group).

The trial’s primary goal (endpoint) was to assess patients’ overall survival and survival rates at 18 months of follow-up in these intermediate and high-risk patients. Secondary endpoints included evaluations of treatment safety and tolerability, tumor response, and patients’ immunological profile.

Topline data from MERECA, recently announced by Immunicum, shows that:

• Among the 45 people vaccinated with ilixadencel and eligible for evaluations of treatment response, five (11%) achieved a complete response (complete tumor eradication), compared to one out of the 25 (4%) evaluable patients given only Sutent after surgery;
• Median overall survival was not reached in any of the groups, indicating both regimens have a high survival rate;
• Survival rates at 18 months of follow-up were similar in both groups (63% among those vaccinated and 66% among those who were not);
• The median progression-free survival (the time patients lived without their disease worsening), and time to progression were similar in patients from both groups;
• Patients’ immunological profile will require further analyses;
• Overall safety and tolerability findings were identical in both treatment groups, and consistent with what has been reported for ilixadencel in other studies.

According to the company, these findings support the development and use of ilixadencel as an effective therapy for kidney cancer and other types of solid cancers.

“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,” Carlos de Sousa, chief executive office of Immunicum, said in a press release.

“We are eager to conduct the full analysis of the data and use that to refine and accelerate ilixadencel’s clinical development,” Sousa added.

The company is planning to present the full data from MERECA at an upcoming scientific conference, and to publish the trial’s findings in an international peer-reviewed science journal.