Adding the off-the-shelf, cell-based immunotherapy ilixadencel to frontline sunitinib was associated with an overall survival benefit in patients with metastatic renal cell carcinoma.
Ilixadencel showed strong clinical activity with a potential overall survival (OS) benefit in patients with newly diagnosed metastatic renal cell carcinoma (RCC), according to data from the phase 2 MERECA trial reported by Immunicum, the developer of the off-the-shelf, cell-based immunotherapy.1
The MERECA trial randomized patients to ilixadencel plus standard frontline sunitinib (Sutent) or sunitinib alone. The findings from the trial showed that the median OS was 35.6 months with the combination compared with 25.3 months with single-agent sunitinib.
“The observed difference of 10 months in median OS for the ilixadencel combination group versus the control group is substantial and clinically meaningful,” Peter Suenaert, MD, PhD, chief medical officer at Immunicum, stated in a press release. “Although the randomized, controlled study was not statistically powered for the OS end point, the data announced today suggests that ilixadencel has the potential to become a promising treatment option for these patients by improving survival outcomes when combined with standard-of-care cancer therapies.”
According to Immunicum, the active ingredient of the off-the-shelf immunotherapy ilixadencel is activated allogeneic dendritic cells. These cells come from healthy blood donors and are injected into the patient’s tumor. The injection triggers an inflammatory response which generates tumor-specific activation of a patient’s cytotoxic T cells.
The open-label, multicenter phase 2 MERECA trial (NCT02432846)2 included 88 patients aged ≥18 years with newly diagnosed metastatic RCC. All patients had to have planned resection of the primary tumor and a tumor size ≥40 mm. Patients enrolling at US trial sites were required to have verified clear-cell tumor histology. Patients were excluded from enrollment if they had a life expectancy ≤4 months or CNS metastases that was either symptomatic, progressing, or required current therapy.
Patients were randomized in a 2:1 ratio to receive ilixadencel prior to nephrectomy followed by post-nephrectomy sunitinib, or nephrectomy followed by sunitinib. Overall survival and 18-month OS rates were the primary end points. Secondary end points included response, safety/tolerability, and immunological profiling including T cell infiltration.
At the time of the evaluation 23 (41%) of 56 patients in the ilixadencel arm were alive. This compared with 9 (30%) of 30 patients in the control group. In the ilixadencel cohort, all 5 patients who achieved a complete response were still alive at the data cutoff. In contrast, the 1 patient with a complete response in the sunitinib-alone arm died during the follow-up period.
“These updated results from the phase 2 MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for kidney cancer patients,” commented Sven Rohmann, MD, PhD, CEO at Immunicum, stated in the press release. “With today’s longer follow-up data, the encouraging signal observed has matured and builds our conviction to bring ilixadencel to patients in need. With our ongoing evaluation of ilixadencel, we are working to provide further clinical evidence supporting our conviction.”
1. Immunicum Announces Encouraging Signs of Survival Benefit in Phase II MERECA Trial of Ilixadencel in Kidney Cancer. Published online February 22, 2021. Accessed February 22, 2021. https://yhoo.it/37AlUmX.
2. NIH ClinicalTrials.gov. Intratumoral Vaccination With Intuvax Pre-nephrectomy Followed by Sunitinib Post-nephrectomy vs Sunitinib Post-nephrectomy in Newly Diagnosed Metastatic Renal Cell Carcinoma (mRCC) (MERECA). Last updated September 4, 2019. Accessed February 22, 2021. https://clinicaltrials.gov/ct2/show/NCT02432846.