Phase 2 MERECA Trial Continues to Show Promise for Ilixadencel-Sunitinib Combination for mRCC

Updated survival data from the randomized phase 2 MERECA trial (NCT02432846) evaluating the off-the-shelf immunotherapy ilixadencel in combination with sunitinib (Sutent) versus sunitinib alone for the first-line treatment of newly diagnosed patients with metastatic renal cell carcinoma (mRCC) demonstrated a separation in Kaplan-Meier survival curves in favor of the combination, according to the agent’s developer, Immunicum AB.

“These updated results from the phase 2 MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for [patients with kidney cancer],” Sven Rohmann, MD, PhD, CEO at Immunicum, said in a 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.”

In the exploratory, international, randomized, controlled, open-label trial, a total of 88 patients with newly diagnosed, intermediate- or poor-risk mRCC were enrolled. Participants were randomized 2:1 to receive either 2 intratumoral doses of ilixadencel before nephrectomy and subsequent treatment with sunitinib or sunitinib therapy alone following nephrectomy.

The study’s dual primary end points are median overall survival (OS) and 18-months survival rates. Key secondary end points include safety and tolerability, tumor response, and immunological profiling, including T-cell infiltration.

In August 2020, the co-primary end point of median OS was reached at 25.3 months in the sunitinib control group, while the median OS in the ilixadencel treatment group had not been reached. Updated data as of February 2021 revealed that the median OS for the ilixandencel combination group has now been reached and was 35.6 months.

Overall, 23 out of 56 patients (41%) in the ilixadencel combination treatment group were still alive, compared with 9 out of 30 patients (30%) in the control group. Moreover, all 5 patients with complete tumor response as best response in the ilixadencel combination treatment group are still alive in this follow-up; this compares favorably with only 1 complete response observed in the control group in a patient who has since died during the first follow-up period.

Moving forward, investigators indicated that survival updates for patients in the MERECA study will be announced for each consecutive 12-month follow-up period.

“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, said in the 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.”

To date, ilixadencel has been tested in a range of clinical trials for various solid tumor indications including mRCC, hepatocellular carcinoma (HCC), and gastrointestinal stromal tumors (GIST). Additionally, the immunotherapy has been evaluated in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors sunitinib and regorafenib (Stivarga) as well as the checkpoint inhibitor pembrolizumab (Keytruda).

Reference:

Immunicum announces encouraging signs of survival benefit in phase II MERECA trial of ilixadencel in kidney cancer. News release. Immunicum. Published February 22, 2021. Accessed February 23, 2021. https://www.globenewswire.com/news-release/2021/02/22/2179199/0/en/Immunicum-Announces-Encouraging-Signs-of-Survival-Benefit-in-Phase-II-MERECA-Trial-of-Ilixadencel-in-Kidney-Cancer.html